CMC Regulatory Affairs Manager

We are seeking a skilled and experienced CMC Regulatory Affairs Manager to join our dynamic team. In this pivotal role, you will oversee the regulatory strategy and submissions related to Chemistry, Manufacturing, and Controls (CMC) for our biopharmaceutical products. Your expertise will ensure compliance with regulatory requirements and support the successf…

Join AbbVie as an Associate Director in Regulatory Affairs with a focus on Chemistry, Manufacturing, and Controls (CMC). In this pivotal role, you will lead cross-functional teams to ensure compliance with regulatory requirements while advancing our innovative therapies. As a leader, you will drive the development of CMC submission strategies, collaborate with internal and external stakeholders, and support the overall regulatory strategy for our product pipeline.

Zenas Bio is at the forefront of biopharmaceutical innovation, dedicated to transforming the lives of patients with autoimmune diseases through the development and commercialization of groundbreaking therapies. Our strategic approach leverages a seasoned leadership team and a meticulous product acquisition strategy to identify, acquire, and develop promising therapies worldwide. We are currently advancing two late-stage candidates: obexelimab and orelabrutinib. Obexelimab, our leading candidate, is a unique bifunctional monoclonal antibody targeting both CD19 and FcγRIIb to inhibit the pathological activity of B cells involved in autoimmune diseases, while preserving their presence. This innovative therapy is designed for self-administration via subcutaneous injection, offering a potentially effective solution for chronic autoimmune conditions. Meanwhile, orelabrutinib is a highly selective, oral Bruton’s Tyrosine Kinase (BTK) inhibitor with the potential to manage compartmentalized inflammation in Multiple Sclerosis (MS). Our earlier-stage pipeline includes a preclinical, oral IL-17AA/AF inhibitor and a brain-penetrant TYK2 inhibitor, both of which hold promise for advancing patient care.We are on the lookout for exceptional talent who share our passion for patient care and have a proven record in product development and commercialization on a global scale. At Zenas, you will thrive in a dynamic learning environment, contributing to our mission of becoming a global leader in immunology and autoimmune disease treatment while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – TRUE Innovation!Position Summary:The Senior Director of Regulatory Affairs (RA) will act as the Global Regulatory Lead for a multi-indication late-phase investigational product, overseeing global regulatory submissions in the US and EU, and contributing to the advancement of Phase 2 indications through clinical development planning. This role will also involve managing regulatory strategies for at least one early-phase investigational product, including the preparation and submission of IND/CTA/amendments and future marketing applications. The Senior Director will provide strategic guidance on regulatory submissions, responses, and essential regulatory intelligence, while collaborating with a diverse cross-functional team and key internal and external stakeholders.

About Oruka Therapeutics Oruka Therapeutics (Nasdaq: ORKA) develops biologics for chronic skin conditions, with a focus on achieving strong disease clearance through infrequent dosing, sometimes as little as once or twice per year. The company’s pipeline includes antibodies engineered by Paragon Therapeutics that target the underlying mechanisms of plaque psoriasis and other dermatological and inflammatory diseases. Learn more at www.orukatx.com. Role Overview Title: Director / Senior Director, Regulatory Affairs Strategy Location: Hybrid preferred (Menlo Park, CA or Waltham, MA). Remote considered. This position serves as Global Regulatory Lead for one or more development programs and reports directly to the Vice President of Regulatory Affairs. The Director/Senior Director will define and execute regulatory strategies to support the global advancement of Oruka’s biologics, with a focus on immunology and dermatology programs. What You Will Do Lead regulatory strategy for assigned programs, translating product goals into actionable development and registration plans. Drive key regulatory milestones and oversee major submissions. Represent Oruka in interactions with health authorities. Identify regulatory risks and opportunities in alignment with company objectives. Collaborate across functions to ensure high-quality, timely global development of the portfolio. What Sets This Role Apart This is a visible leadership role with influence over the regulatory direction of programs aiming for infrequent dosing, strong efficacy, and lasting results in psoriasis and related conditions. The position offers the chance to shape strategies for a pipeline of engineered antibodies intended to change how chronic skin diseases are treated.

Join Our Mission:Oruka Therapeutics (Nasdaq: ORKA) is at the forefront of developing cutting-edge biologics aimed at revolutionizing the treatment of chronic skin diseases. Our commitment is to provide patients afflicted by conditions such as plaque psoriasis with unprecedented freedom by achieving significant disease clearance with infrequent dosing—sometimes as little as once or twice a year. We are advancing a proprietary pipeline of potentially best-in-class antibodies that target the fundamental mechanisms of plaque psoriasis and other dermatological and inflammatory ailments. Discover more about us at www.orukatx.com.As we expand our core team, we are looking for exceptional individuals who are not just seeking employment but are passionate about contributing to a broader cause. We value candidates who are eager to foster an inclusive and dynamic company culture.Position Overview:We are in search of a seasoned and motivated leader in regulatory CMC to shape our strategy and execution across various stages of biologics programs. In this role, you will be responsible for the development of high-quality regulatory CMC submissions and will provide guidance to cross-functional teams on global regulatory expectations appropriate for different phases. Ideal candidates will bring extensive expertise in biologics development and manufacturing, particularly in drug substance and product CMC submissions. You will play a crucial role in influencing program strategies, facilitating collaboration across CMC, QA, RA, Supply Chain, and external partners, and driving pivotal decisions that support our expanding biologics pipeline. This highly visible role involves ensuring compliance with FDA, EMA, ICH, and WHO guidelines while meeting corporate and program-level objectives.

Zenas Bio is a pioneering clinical-stage global biopharmaceutical organization dedicated to becoming a frontrunner in the development and commercialization of groundbreaking therapies for patients suffering from autoimmune diseases. Our strategic vision combines an accomplished leadership team with a meticulous approach to product candidate acquisition, enabling us to identify, acquire, and develop innovative products worldwide that offer significant clinical benefits to patients living with autoimmune conditions. Zenas is advancing two late-stage potential franchise molecules: obexelimab and orelabrutinib. Obexelimab, our flagship product candidate, is a bifunctional monoclonal antibody designed to bind both CD19 and FcγRIIb, prevalent across B cell lineages, to inhibit the activity of cells implicated in various autoimmune diseases without depleting them. We are confident that obexelimab’s unique mechanism of action and its self-administered, subcutaneous injection regimen can effectively address the pathogenic role of B cell lineages in chronic autoimmune diseases. Orelabrutinib represents a potentially best-in-class, highly selective CNS-penetrant, oral small molecule Bruton’s Tyrosine Kinase (BTK) inhibitor, promising to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Our earlier-stage programs also include a preclinical, potentially best-in-class, oral IL-17AA/AF inhibitor and a preclinical, brain-penetrant, oral TYK2 inhibitor.We are on the lookout for exceptional talent who share our dedication to patients and possess a proven track record in acquiring, developing, and commercializing products on a global scale. Our team members enjoy a dynamic learning environment where they can achieve both individual and organizational success as we strive to become a global leader in immunology and autoimmune disease, while embodying our core values of Transparency, Relationships, Urgency, Excellence, and Innovation – the essence of TRUE Innovation!Position Summary:The Director of Regulatory Affairs will lead the daily regulatory activities of early and late-phase investigational products, steering the writing and submission of IND/CTA/amendments and future marketing applications. This role will provide essential guidance to the team on regulatory filings and responses while delivering critical regulatory intelligence back to the team. The Director will collaborate within a cross-functional team, partnering with key internal and external stakeholders, and work alongside Regulatory CMC, Medical Writing, and Regulatory Operations to ensure that scientific data and submissions meet agency expectations in a compliant manner. This position will report directly to the Executive Director of Global Regulatory Affairs.

Role Overview Sobi is hiring a US Regulatory Strategy Lead in Waltham. This role shapes regulatory strategies for the company’s therapies and works closely with teams across the organization. The position focuses on ensuring compliance and guiding products through approval processes. What You Will Do Develop and refine regulatory strategies for therapies in the US market Collaborate with cross-functional teams to support product submissions and approvals Help maintain compliance with relevant regulations throughout the development process Contribute to efforts that aim to improve patient outcomes through successful product launches

Join Sobi as the Director of Global Regulatory Advertising and Promotion, where you will lead the development and execution of regulatory strategies for advertising and promotional materials across global markets. Your expertise will ensure compliance with regulatory standards while driving innovative marketing initiatives that resonate with healthcare professionals and patients alike.

As the Director of Regulatory Advertising and Promotion for North America at Sobi, you will spearhead the strategic direction and oversight of all regulatory aspects related to advertising and promotional activities. This role is pivotal in ensuring compliance with all relevant regulations while promoting our innovative products within the market.

Join AbbVie as an Associate Director in our CMC-Pharma Product Group, where you will play a pivotal role in leading cross-functional teams to drive the development and manufacturing of high-quality pharmaceutical products. Your expertise will be crucial in ensuring compliance with regulatory standards and enhancing our product portfolio.

Sobi is seeking a Senior Medical Director of Rheumatology to join the Medical Affairs team in Waltham. This role centers on setting direction for rheumatology initiatives and collaborating with leading experts in the field. Key responsibilities Shape the medical strategy for rheumatology within Medical Affairs Guide research efforts to support new and ongoing projects Work closely with top professionals in rheumatology to advance patient care Impact The Senior Medical Director will play a central role in improving patient outcomes and supporting the development of new treatments in rheumatology. Location This position is based in Waltham.

Zenas is a pioneering biopharmaceutical organization at the forefront of developing and commercializing innovative therapies for individuals suffering from autoimmune diseases. Our strategic approach integrates a seasoned leadership team with a focused acquisition strategy aimed at identifying and cultivating product candidates on a global scale, ensuring they deliver exceptional clinical benefits to patients. Currently, Zenas is advancing two promising late-stage molecules: obexelimab and orelabrutinib. Obexelimab, our flagship candidate, is a bifunctional monoclonal antibody tailored to bind both CD19 and FcγRIIb, effectively inhibiting the activity of B cell lineage cells implicated in various autoimmune conditions, all while sparing their depletion. We believe obexelimab’s unique mechanism of action and self-administered subcutaneous injection could significantly influence the treatment landscape of chronic autoimmune diseases. Orelabrutinib is a potentially leading, selective CNS-penetrant, oral Bruton’s Tyrosine Kinase (BTK) inhibitor, designed to tackle compartmentalized inflammation and disease progression in Multiple Sclerosis (MS). Our early-stage initiatives include groundbreaking preclinical candidates targeting IL-17AA/AF and TYK2.We invite driven professionals who share our passion for patient care and possess a proven track record in product acquisition, development, and commercialization on a global scale. At Zenas, team members are immersed in a dynamic learning environment, paving the way for both personal and organizational success as we strive to become leaders in immunology and autoimmune disease treatment, all while adhering to our core values of Transparency, Relationships, Urgency, Excellence, and TRUE Innovation!Position Summary:The Director of Advertising and Promotion will spearhead the regulatory strategy and oversight for Zenas’ product labeling and promotional activities. This role will establish the company’s expertise in FDA regulations, guidance, and enforcement trends regarding advertising, promotion, and labeling. The Director will ensure that all promotional and non-promotional materials comply with regulatory standards and will work collaboratively with cross-functional teams to support both developmental and commercial goals. This position reports directly to the Executive Director of Global Regulatory Affairs.

AbbVie is seeking a highly skilled and experienced Scientific Director or Medical Director to lead our Medical Affairs team specializing in Oncology, specifically focusing on Ovarian Solid Tumor. In this pivotal role, you will be responsible for driving strategic initiatives, providing medical insights, and collaborating with cross-functional teams to enhance patient outcomes through innovative therapies.

Join Deciphera Pharmaceuticals as a Medical Science Liaison II, where you will play a pivotal role in bridging the gap between our innovative research and the medical community. Your expertise will help communicate the value of our products and support healthcare professionals in enhancing patient care.In this role, you will engage with healthcare providers, deliver scientific presentations, and provide educational support, all while collaborating with cross-functional teams to ensure alignment with our strategic objectives.

We are seeking a dedicated and dynamic Program Manager to join our team at Integrated Resources, Inc. in Waltham, Massachusetts. As a Program Manager, you will play a crucial role in leading and coordinating various projects, ensuring they are executed efficiently and effectively. Your expertise will help drive our initiatives forward, fostering collaboration across teams and stakeholders.

ElevateBio is a pioneering technology firm that accelerates the advancement of the biotechnology sector by enabling partners to unlock the full potential of their therapies, from conception through to market launch. Our unique combination of cutting-edge technologies, comprehensive services, and top-tier manufacturing expertise allows us to develop advanced therapies more efficiently and effectively.The Role:We are seeking a detail-oriented and analytics-driven CRM Manager to take charge of our HubSpot platform, enhancing both marketing and sales effectiveness. This pivotal role will involve managing marketing automation efforts, ensuring data integrity, and delivering actionable insights that promote revenue growth. The ideal candidate will possess strong technical skills along with a strategic mindset, coupled with a fervent commitment to optimizing processes and empowering teams through proficient CRM utilization.Key Responsibilities:Act as the primary system administrator and expert for the HubSpot platform, overseeing user roles, system configurations, and daily operations to guarantee peak performance.Design, implement, and manage multi-step lead nurturing campaigns and marketing automation workflows in HubSpot, effectively guiding prospects through the buying journey and providing marketing-qualified leads to the sales team.Proactively oversee the health and integrity of the HubSpot database, conducting regular data cleansing, deduplication, and enrichment to maintain the accuracy of all commercial data.Create and manage dashboards and reports to meticulously track and analyze campaign performance, delivering clear insights on open rates, click-through rates, conversion, and pipeline influence to the Director of Commercial Excellence.Develop dynamic and static contact lists to facilitate precise audience segmentation for targeted email campaigns, sales outreach, and event invitations.Collaborate closely with the sales team to develop and refine HubSpot assets that enhance efficiency, including email templates, sales sequences, and lead scoring models that prioritize outreach efforts.Generate comprehensive documentation for HubSpot processes and provide ongoing support and training to sales and marketing teams, ensuring adherence to best practices and fostering platform adoption.

As a Senior Manager of Clinical Data Management at Deciphera Pharmaceuticals, you will lead and oversee the clinical data management function, ensuring high-quality data collection and management practices. You will play a pivotal role in supporting clinical trials through the oversight of data management processes, and collaborate with cross-functional teams to ensure timely and accurate delivery of data for analysis.

Xometry (NASDAQ: XMTR) is at the forefront of transforming industries by bridging innovative minds with manufacturers capable of realizing their visions. Our cutting-edge digital marketplace equips manufacturers with essential resources to expand their businesses, while enabling Fortune 1000 buyers to leverage global manufacturing capabilities effortlessly.We are seeking a dynamic Senior Category Manager based in Boston, Maryland, DC, or Northern Virginia to strategically drive the growth of our Additive business. In this role, you will define and implement comprehensive category strategies, tackle complex challenges, execute tactical initiatives, and monitor key performance indicators. Successful Category Managers will possess exceptional negotiation skills and excel in cross-functional project management.

Role Overview Crescent Biopharma is seeking a Senior Manager or Associate Director of Clinical Data Management based in Waltham, MA. This position leads data management activities for clinical trials, guiding teams to uphold data integrity and meet regulatory requirements. What You Will Do Direct and oversee data management operations for clinical studies. Ensure all processes align with regulatory standards and internal protocols. Work closely with cross-functional partners to improve data collection and analysis methods. Support the development of new therapies by maintaining high-quality clinical data. What Crescent Biopharma Looks For Strategic mindset with strong leadership abilities. Experience managing data in clinical trial settings. Commitment to data accuracy and regulatory compliance. Effective collaboration with diverse project teams.

Join Xometry, a leader in on-demand manufacturing, as a Talent Management Program Manager. In this pivotal role, you will spearhead initiatives to enhance our talent acquisition and development strategies, ensuring we attract and retain top talent in the industry. You will collaborate with various departments to design and implement innovative talent management programs that align with our organizational goals.