Director of Global Regulatory Strategy

AbbVie is seeking a strategic and visionary leader for the role of Director of Global Regulatory Strategy. In this position, you will be responsible for developing and implementing innovative regulatory strategies that support AbbVie's global product portfolio. You will lead a team of regulatory professionals and collaborate with cross-functional teams to en…

AbbVie is seeking a dynamic and experienced Director of Global Regulatory Strategy to lead our regulatory team in Boston. This pivotal role involves developing and implementing comprehensive regulatory strategies that ensure the successful approval of our innovative therapies. As a key member of our leadership team, you will collaborate with cross-functional partners to navigate the complexities of global regulatory landscapes.

We are seeking an experienced Associate Director of Global Regulatory Strategy to drive our international regulatory initiatives. This pivotal role will involve developing and executing regulatory strategies for our innovative therapies aimed at treating serious diseases. You will collaborate closely with cross-functional teams to ensure compliance and facilitate the successful progression of our clinical programs.

At Olema Oncology, we are committed to pioneering advanced therapies for breast cancer and beyond. Our flagship program, palazestrant (OP-1250), is an innovative complete estrogen receptor antagonist (CERAN) currently undergoing development for metastatic breast cancer, showing significant promise as both a monotherapy and in combination therapy for ER+/HER2- metastatic breast cancer. Additionally, our next candidate, OP-3136, is a leading KAT6 inhibitor with potential to set new standards in treatment.Our scientific advancements are driven by an environment that encourages fearless support, motivation, and collaboration. At Olema, we believe that prioritizing our team leads to exceptional outcomes. If you are prepared to be part of something transformative, let’s collaborate to create meaningful impacts for our patients, your career, and the future of medicine.For more insights, view our latest corporate presentations here.About the Role: Senior Director, Global Regulatory Strategy Lead - Regulatory AffairsIn the position of Senior Director, Global Regulatory Strategy Lead - Regulatory Affairs, reporting to the Senior Vice President of Regulatory Affairs, your key responsibilities will include:Leading the development of the New Drug Application (NDA).Creating and implementing innovative regulatory strategies that support Olema's product portfolio.Acting as the subject matter expert for Regulatory Affairs on cross-functional teams, providing guidance to global project teams, Study Execution Teams, and the Executive Committee.Offering strategic and tactical oversight for the development of regulatory submissions, including INDs, CTx, briefing documents, IB, NDA, BLA, DMF, IMPD, etc.This role is based in either our Boston, MA or San Francisco, CA office and will involve domestic and international travel of up to 20%.This role will primarily involve:Leading the NDA development and submission for our lead programFormulating innovative global regulatory strategies for the Olema product suite, addressing both clinical development and lifecycle management as required.Representing Regulatory Affairs on cross-functional teams as the SME, delivering regulatory guidance and oversight to global project teams, Study Execution Teams, and the Executive Committee.

As the Director of Global Regulatory Strategy at AbbVie, you will lead and drive the development of regulatory strategies for our innovative products. You will collaborate cross-functionally with various teams to ensure compliance with regulatory requirements, facilitating successful product launches globally.

At Veeva Systems, we are dedicated to revolutionizing the life sciences industry through innovative cloud-based solutions. Our mission is to accelerate the delivery of therapies to patients, and we've established ourselves as a leader in this space, achieving over $3 billion in revenue last fiscal year. As a rapidly expanding SaaS company, we are poised for significant growth in the years to come. Our core values drive us: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), ensuring a commitment to balancing the needs of our customers, employees, society, and investors. As a Work Anywhere organization, we value flexibility, allowing you to choose whether to work from home or in the office to maximize your productivity and comfort. Join us as we transform the life sciences landscape and make a meaningful impact on our customers, employees, and communities.About the Role In the capacity of Director of Regulatory Market Strategy, you will serve as the leading authority on Regulatory Information Management (RIM) at Veeva. This is a prestigious, non-managerial role, focusing on mastering the complexities of regulatory requirements and aligning them with cutting-edge software solutions. Your primary responsibility will be to enhance Veeva’s market share in regulatory products. What Makes This Role Stand OutStrategic Influence: Instead of managing a team, you will shape the strategies that enable biotech companies to navigate critical health authority submissions.Expertise Matters: Leveraging your dual expertise as an Operator and Consultant, you will provide insightful guidance that resonates with clients. Your experience will empower you to demonstrate how strategies can be applied effectively in global submissions.Commercial Significance: You will be more than a support role; you will be a key player in identifying market opportunities and collaborating with Product teams to ensure Veeva maintains its position as an industry leader. What This Role Is NOTNo People Management: You will be an elite individual contributor, with success evaluated based on market impact rather than team size.Not Regulatory Affairs or Science: This role is about designing systems to enhance product delivery to market, not developing regulatory strategies for sponsors.Transformative Technology Solutions: Your focus will be on delivering effective technology solutions that drive change.

About EyebotEyebot is a visionary technology firm dedicated to revolutionizing vision care accessibility for all. Based in the vibrant North End of Boston and supported by esteemed investors and the National Science Foundation, our innovative vision test kiosk is transforming the delivery of vision care.If you are driven by the passion to tackle significant challenges while helping to shape the future of vision care, we eagerly invite you to connect with us.About the RoleWe are seeking a dynamic Head of Regulatory Strategy & Clinical Development to chart our market approach. In this pivotal role, you will craft and implement the FDA regulatory strategy for our cutting-edge AI-powered ophthalmic diagnostic platform, managing 510(k) submissions, Pre-Submissions, and CE marking compliance under the EU MDR. This leadership position offers direct visibility to executives and significant influence over product outcomes.Your Responsibilities:U.S. FDA StrategyEstablish and execute comprehensive FDA regulatory strategies, including predicate selection, intended use definition, and risk assessment.Lead the drafting and submission of Pre-Submission and 510(k) applications from inception to clearance.Act as the primary liaison for all FDA interactions, including meetings, Q-Submissions, and formal communications.Ensure risk management, labeling, and software documentation align with FDA guidelines.EU CE MarkingDirect the EU MDR regulatory strategy and manage the CE marking process comprehensively.Create and uphold the Technical File; facilitate interactions and audits with Notified Bodies.Monitor post-market surveillance and vigilance, ensuring consistency between U.S. and EU regulatory perspectives.Clinical Strategy & ExecutionIdentify when clinical evidence is necessary and specify the required evidence scope.Design and implement clinical study protocols and statistical analysis plans.Oversee IRB submissions, site coordination, study execution, data integrity, and final reporting.Program & Cross-Functional LeadershipManage regulatory program timelines across hardware, software, clinical, and labeling workflows.

At Real Chemistry, our mission is to create a healthier world every day. We leverage our profound scientific knowledge, human-centered creativity, and AI-driven insights to foster a dynamic environment where innovation flourishes and our team is dedicated to making a meaningful impact. As a global agency, we offer comprehensive healthcare communication and marketing services to our clients, including leading companies in the pharmaceutical and biotech sectors.Our #LifeatRealChem culture emphasizes the importance of our people—we believe in collaboration and strive for excellence for our clients and colleagues. Whether you are an experienced professional or starting your career journey, if you share our enthusiasm for healthcare and connection, we encourage you to explore our opportunities.Discover your purpose. Embrace innovation. Experience #LifeatRealChem.Real Chemistry is excited to invite a strategic and dynamic individual to join our team as the Director of Strategy! 21GRAMS, part of Real Chemistry, adopts a unique approach to advertising with a focus on humanizing healthcare. This philosophy extends beyond our work, influencing how we build client relationships and interact with each other. We embody the saying, “Be good to each other, but hard on the work.” This is a place where individuals are motivated not just by financial rewards, but by the desire to make a significant difference. Does this resonate with you?In this pivotal role, you will guide the strategic direction of our company, collaborating closely with senior leadership to identify, develop, and implement initiatives that align with our long-term growth objectives. You will work alongside various teams to develop and execute strategies, and you will be responsible for analyzing information related to proposals and presenting them to executives or clients.This is a hybrid position, allowing you to work from any of our US offices, including Boston, Chicago, Carmel, Lambertville, San Francisco, or New York City, or remotely within the US, based on team and business needs.

Join Veeva Systems, a trailblazer in industry cloud, dedicated to accelerating the delivery of therapies to patients worldwide. As one of the fastest-growing SaaS companies in history, we've achieved over $3 billion in revenue in our last fiscal year, with even greater growth potential on the horizon. Our core values drive us: Do the Right Thing, Customer Success, Employee Success, and Speed. In a groundbreaking move, we became a public benefit corporation in 2021, ensuring we balance the interests of our customers, employees, society, and investors. As a Work Anywhere organization, we offer flexible work arrangements, empowering you to thrive in your preferred setting. Be part of our mission to transform the life sciences industry while making a positive impact on our customers, employees, and communities.Role OverviewAs the Global Network MDM Strategy Lead, you will take on a CEO-like role for the Network MDM business, responsible for the product's overall success. This encompasses developing the Network MDM product strategy, go-to-market initiatives, and ensuring customer success. You will engage directly with customers at the senior level, fostering key relationships and guiding senior discussions. Additionally, you will oversee the information flow to sales teams and contribute to the planning and execution of our customer events.

At Real Chemistry, our commitment to making the world a healthier place is more than a goal – it’s our daily reality. We harness a unique blend of scientific expertise, human-centered creativity, and AI-driven insights to drive innovation in healthcare. As a leading global agency, we offer a comprehensive range of services in healthcare communications and marketing to esteemed clients in the pharmaceutical and biotech sectors.Our vibrant culture at #LifeatRealChem is built around our people; we thrive in collaboration and strive for excellence, both for our clients and our colleagues. Whether you are an experienced professional or just beginning your career journey, if you share our dedication to healthcare and meaningful connections, we encourage you to explore our opportunities.Find your purpose. Embrace innovation. Experience #LifeatRealChem.Job Summary:Real Chemistry is excited to invite an Associate Director of Strategy to our expanding team!21GRAMS, a division of Real Chemistry, approaches advertising with a focus on humanizing healthcare. We believe in fostering positive relationships, both internally and externally, and adhere to the principle of 'Be good to each other, but hard on the work.' If you’re looking to make a meaningful impact, this is the place for you.This hybrid role may be based in any of our US offices—including New York City, Boston, Chicago, Carmel, Lambertville, or San Francisco—or can be performed remotely, depending on team and business needs.Responsibilities:Lead the creation of brand positioning, messaging, and creative briefs that effectively relay our brand narrative.Collaborate closely with cross-functional teams, including Account Management, Creative, and Project Management, to design integrated omnichannel campaigns that yield measurable outcomes.Stay updated on industry trends, emerging technologies, and best practices in omnichannel strategy.

Veeva Systems is a pioneering, mission-driven organization at the forefront of cloud technology for the life sciences sector, dedicated to accelerating the delivery of therapies to patients. As one of the fastest-growing SaaS companies in history, we achieved over $3 billion in revenue last year, with significant opportunities for continued growth. At Veeva, our core values drive us: Do the Right Thing, Customer Success, Employee Success, and Speed. We made history in 2021 by becoming a public benefit corporation (PBC), committed to balancing the interests of our customers, employees, society, and investors. As a Work Anywhere company, we offer the flexibility to work either from home or in the office, allowing you to excel in your preferred environment. Join us in transforming the life sciences industry and making a positive impact on our customers, employees, and communities.The Role As the Director of HCP Access Strategy, you will serve as the “market owner” or “CEO” of Veeva’s HCP Access data product in the United States. This product delivers unique access metrics derived from Veeva's CRM activities, offering revolutionary Wisdom of the Crowd data crucial for our customers' HCP segmentation, targeting, and AI initiatives.Your role will be highly visible within Veeva Data Cloud, where you will drive the long-term growth of HCP Access in the US market.

Veeva Systems is a visionary company dedicated to transforming the life sciences industry by enabling companies to expedite the delivery of therapies to patients. As one of the most rapidly expanding SaaS companies, we achieved over $2 billion in revenue in our last fiscal year, with immense growth potential on the horizon.Our core values—Do the Right Thing, Customer Success, Employee Success, and Speed—are fundamental to our identity. In 2021, we made history by becoming a public benefit corporation (PBC), which legally commits us to balancing the interests of our customers, employees, society, and investors.As a Work Anywhere organization, we empower our employees with the flexibility to choose their work environment, whether from home or in the office, to maximize their productivity and comfort.Join us in transforming the life sciences industry while making a significant impact on our customers, employees, and communities.

Veeva Systems is hiring a Senior Director of Global Migration Services based in Boston, Massachusetts. This leadership role guides migration initiatives worldwide, setting direction and ensuring projects meet both business objectives and client standards. Role overview The Senior Director will shape the strategy, planning, and delivery of migration projects on a global scale. The position calls for close collaboration with teams from different departments to strengthen service offerings and improve operational results. What you will do Lead and manage global migration projects from strategy through execution Align migration work with company goals and client requirements Work with cross-functional teams to refine and expand migration services Promote operational excellence throughout all stages of migration Requirements Extensive experience managing large-scale migration projects Proven ability to develop and execute strategic plans Strong collaboration skills with cross-functional teams Track record of driving improvements in service delivery

Join Klaviyo as a Senior Director of Digital Strategy, where you will spearhead innovative digital initiatives and drive our marketing efforts to new heights. This leadership role requires a visionary who can harness data-driven insights to craft compelling digital experiences that resonate with our customers.

Join our dynamic team as a Sales Strategy Analyst/Associate within our Global Client Solutions division. In this pivotal role, you will be responsible for analyzing market trends, supporting strategic initiatives, and collaborating with cross-functional teams to drive sales performance. Your analytical skills will be essential in crafting data-driven insights that inform our sales strategies and enhance client engagement.

Join Veeva Systems, a pioneering mission-driven organization that is revolutionizing the life sciences sector by enabling companies to deliver therapies to patients more swiftly. As one of the fastest-growing SaaS companies in history, we proudly achieved over $2 billion in revenue last year, with an exciting trajectory of further growth.At the core of Veeva are our guiding principles: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), committed to balancing the needs of our customers, employees, society, and investors.As a Work Anywhere company, we embrace the flexibility of working from home or in the office, allowing you to thrive in your preferred environment.Join us in transforming the life sciences industry and making a meaningful impact on our customers, employees, and communities.The RoleVeeva Link is dedicated to enhancing engagement with Key Opinion Leaders in Healthcare. Our applications vary in maturity, with some being industry standards while others are in their early stages. There’s a wealth of knowledge to absorb and ample opportunities for professional growth. Our Strategy team is pivotal to the market success of our products, overseeing everything from product development to client satisfaction. We are seeking a candidate who embodies our relentless drive to transform the industry, possesses expertise in biopharma and technology, and is genuinely passionate about building relationships.

About SimpliSafeAt SimpliSafe, we are dedicated to a straightforward mission: ensuring that every home is secure. We believe that safety should be accessible, intelligent, and effortless for all. Over the past decade, we have transformed home security through innovative hardware, professional monitoring, and a customer-centric philosophy. As we continue to expand our subscription services, enhancing customer engagement, retention, and sustainable revenue growth is pivotal to our long-term success.We promote a hybrid work environment that allows our teams to balance their time effectively between the office and home. Our hybrid model encourages collaboration in our modern office on two core days, usually Tuesday, Wednesday, or Thursday, with the flexibility to work remotely the rest of the week. This approach allows us to maximize productivity while enjoying the best of both worlds.Why Join Us?We are experiencing tremendous growth and success, which is why we are seeking intelligent, talented, and humble individuals who align with our values to help us revolutionize the home security industry and tirelessly pursue our mission of safeguarding every home.Role OverviewWe are looking for a Director of Product to spearhead Experience Strategy—a critical function responsible for shaping SimpliSafe's long-term product vision and delivering significant new features within our integrated product and customer marketing lifecycle organization. This role focuses on a 12-month-plus horizon, envisioning the future of the SimpliSafe protection experience, developing a strategic roadmap, and overseeing the successful launch of new capabilities. Once a new feature is implemented—be it a new service, a revamped experience, or an advanced intelligence feature—the Director will collaborate with the Revenue & Retention team to enhance and optimize it in alignment with subscriber value objectives.You will not only be tasked with strategic planning but also with executing the vision. Your contributions will manifest as tangible product features that the Activation & Adoption and Revenue & Retention teams can market, rather than mere presentations or frameworks. Success in this role means establishing a clear long-term direction for the organization, ensuring timely delivery of major capabilities, and achieving the customer lifetime value outcomes these capabilities are designed to support.Collaboration will be key as you work closely with the Director of Revenue & Retention, who manages in-market performance, and the Director of Activation & Adoption, who focuses on the initial subscriber experience, ensuring that all three areas contribute to a cohesive and differentiated protection experience.

Veeva Systems is a purpose-driven leader in industry cloud solutions, dedicated to helping life sciences companies accelerate the delivery of therapies to patients. Recognized as one of the fastest-growing SaaS companies in history, we achieved over $2 billion in revenue last year and are poised for continued growth.Veeva's core values are integral to our culture: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), committed to balancing the needs of our customers, employees, society, and investors.As a Work Anywhere organization, we empower you to work flexibly, whether from home or in the office, supporting your optimal work environment.Join us in transforming the life sciences industry, as we strive to make a meaningful difference for our customers, employees, and communities.The RoleAs part of Veeva Link, you will play a crucial role in redefining how the life sciences sector engages with the healthcare community to improve patient outcomes.Our offerings cover the entire product lifecycle, including our leading KOL platform and innovative tools that revolutionize how pharmaceutical companies gather and utilize real-world insights. As a member of the Link Strategy Team, you will act as a vital connector between Product, Sales, and Services, not only supporting the business but also crafting a market-facing vision that guarantees our products provide substantial value to the industry.In this rapidly evolving landscape, we seek individuals who demonstrate ownership and embody our core principles:• Lead Intentionally: Define a clear vision and inspire others to join you.• Execute Flexibly: Adapt and excel in a dynamic market.• Own Enthusiastically: Take comprehensive responsibility for the success of our platforms.This role presents a unique opportunity to influence the go-to-market strategy for cutting-edge platforms in a high-growth and flexible environment, where your contributions directly impact patient lives.

At Veeva Systems, we are a pioneering force in industry cloud solutions, dedicated to expediting the delivery of therapies to patients in the life sciences sector. As one of the fastest-growing SaaS companies globally, we achieved over $2 billion in revenue in our last fiscal year, with an exciting trajectory ahead.Our core values drive us: Do the Right Thing, Customer Success, Employee Success, and Speed. We are more than just a publicly traded company; in 2021, we made history by becoming a public benefit corporation (PBC), which legally binds us to consider the interests of customers, employees, society, and investors alike.As a Work Anywhere organization, we embrace your flexibility to work from home or in the office, allowing you to thrive in your preferred environment.Join us to revolutionize the life sciences industry and make a positive impact on our customers, employees, and communities.Position OverviewVeeva Link is committed to transforming relationships with Key Opinion Leaders in Healthcare. We have multiple applications at varying levels of maturity, some setting the industry standard while others are emerging solutions. There is ample opportunity for learning and growth within our team. Our Strategy team is integral to the market success of our products, guiding them from inception to client success. We are in search of a driven individual who shares our relentless passion for industry transformation, possesses expertise in biopharma and technology, and is enthusiastic about fostering relationships.

Veeva Systems is a pioneering organization dedicated to transforming the life sciences sector through innovative industry cloud solutions. Our mission is to expedite the delivery of therapies to patients, and our impressive growth trajectory reflects our commitment, having surpassed $3 billion in revenue in the last fiscal year. At Veeva, our core values are paramount: Do the Right Thing, Customer Success, Employee Success, and Speed. In 2021, we made history by becoming a public benefit corporation (PBC), ensuring a balanced approach to serving the interests of our customers, employees, society, and investors. As a Work Anywhere company, we empower you to choose your ideal work environment, whether at home or in the office, to maximize your potential. Join us in revolutionizing the life sciences landscape, with a commitment to making a meaningful impact on our customers, employees, and the communities we serve.