Qualifications
Proven experience in regulatory writing, with a deep understanding of FDA regulations and guidelines. Strong leadership skills with the ability to mentor and develop team members. Excellent communication and interpersonal skills, capable of working cross-functionally. Master’s degree in a relevant field is preferred. Minimum of 5 years of experience in regulatory affairs or related fields.
About the job
Join AbbVie as an Associate Director of Regulatory Strategic Writing, where your expertise will guide the development of regulatory documents that meet high-quality standards. You will lead a team of skilled writers who craft critical submissions, ensuring compliance with regulatory requirements while advocating for innovative solutions.
This role demands a strategic mindset, exceptional writing skills, and the ability to collaborate across departments. You will oversee the preparation of regulatory submissions, including but not limited to INDs, NDAs, and BLAs, ensuring clarity and compliance throughout the process.
About AbbVie Inc.
AbbVie Inc. is a global, research-based biopharmaceutical company that creates innovative medicines to treat complex health issues. Committed to improving patient outcomes, AbbVie invests in scientific research and collaborates with healthcare professionals to deliver transformative therapies.