Associate Director, Regulatory Affairs, CMC

📋 Description

• Serve as the regulatory CMC strategy liaison for project teams, providing CMC-related regulatory input for assigned projects/products.

• Develop or contribute to submission strategy documents by specifying supplement types, necessary data to support submissions, and documentation required for the submission package.

• Assist the project team during the planning phase to ensure the correct data (and detail level) is collected and submitted to meet the needs of all markets.

• Draft and review individual CMC submission documents/CMC dossier sections to facilitate regulatory submissions.

• Offer consistent expert guidance to the organization, assessing feasible regulatory strategies and identifying potential options to enhance business value or alleviate compliance issues.

• Maintain registration tracking information and support the establishment of effective document management practice standards.

• Collaborate closely with global Regulatory Affairs and regional Regulatory Affairs teams to address inquiries from regulatory authorities.

⛳️ Requirements

• Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or a related field (Doctor of Pharmacy (PharmD) or MSc in radiopharmacy preferred).

• At least 3 years of experience in Regulatory Affairs or Quality, with a proven history of supporting marketed products and/or the clinical development of radiopharmaceuticals.

• Knowledge of PET production, automated synthesis (cassette-based systems), and GMP standards for radiolabeled compounds.

• Experience with regulatory submissions for post-approval changes, including FDA supplements and EU variations.

• Proficiency in prioritizing, planning, and evaluating deliverables to meet established strategic goals for complex projects, including scientific discussions on optimal information presentation.

• Strong problem-solving and negotiation skills.

• Proven experience operating within a highly regulated environment.

• Ability to apply analytical skills in a CMC regulatory context.

• Experience working in a matrix organization with strong interpersonal and influencing capabilities to collaborate across disciplines.

• Ability to influence managers and drive decisions at the project level.

• Demonstrated knowledge and experience in scientifically related fields such as pharmaceutical sciences, chemistry, and analytical sciences.

• Excellent written and oral English skills to effectively present information to relevant audiences.

• Experience in pharmaceutical CMC regulatory or QA environments, particularly with injectable diagnostic or pharmaceutical products.

• Capability to interpret global regulations and communicate findings to the wider business.

• Familiarity with electronic document management and Quality management systems.

• Proactive in championing projects and experienced in mentoring team members.

• Understanding of international CMC regulatory requirements.

• Strong interpersonal abilities with the capacity to engage effectively with colleagues at all organizational levels.

• Prior experience interacting with regulatory agencies (e.g., responding to queries, scientific advice, and deficiency letters).

• Background in global regulatory affairs within the pharmaceutical and/or healthcare sectors.

• Experience in regulatory project management and regulatory agency interactions.

• Familiarity with Veeva RIM or other registration tracking tools.

• Ability to work across diverse cultures, countries, and sites.

• Proven experience in prioritizing conflicting demands from multiple business entities in a highly dynamic environment.

🏝️ Benefits

• Medical

• Dental

• Vision

• Paid time off

• A 401(k) plan with employee and company contribution opportunities

• Life, disability, and accident insurance

• Tuition reimbursement