Associate Director, Regulatory Affairs, CMC

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Develop or contribute to submission strategy documents by specifying the type of supplement, data necessary for support, and the documentation needed for the submission package.

• Advise the project team during the planning phase to ensure the correct data (and level of detail) is gathered and submitted to meet the requirements of all markets.

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

• Offer consistent expert guidance to the organization, determining viable regulatory strategies and identifying potential options to maximize business value or address compliance issues.

• Maintain registration tracking data and aid in establishing robust document management practices.

• Collaborate closely with global RA and regional RAs to respond to inquiries from regulatory authorities.

⛳️ Requirements

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

• 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 requirements for radiolabeled compounds.

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

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

• Strong problem-solving and negotiation abilities.

• Proven experience in a highly regulated environment.

• Capable of utilizing analytical skills within a CMC regulatory context.

• Experience working in a matrix organization, possessing strong interpersonal and influencing skills to collaborate across disciplines.

• Ability to influence managers and aid in decision-making at the project level.

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

• Strong proficiency in written and spoken English for effectively communicating information to the relevant audience.

• Background in pharmaceutical CMC regulatory or QA environments, especially with injectable diagnostic or pharmaceutical products.

• Capability to interpret global regulations and convey them to the broader organization.

• Familiarity with electronic document management and quality management systems.

• Ability to actively promote projects and mentor team members.

• Understanding of international CMC regulatory requirements.

• Excellent interpersonal skills to engage effectively with colleagues at all levels.

• Previous regulatory agency interaction experience (e.g., responding to queries, providing scientific advice, addressing deficiency letters).

• Experience in global regulatory affairs within the pharmaceutical and/or healthcare industries.

• Background in regulatory project management and interactions with regulatory agencies.

• 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 various business entities in a fast-paced environment.

🏝️ Benefits

• Medical

• Dental

• Vision

• Paid time off

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

• Life insurance

• Disability insurance

• Accident insurance

• Tuition reimbursement