Associate Director, Regulatory Affairs, CMC

Job Description

Summary We are seeking a highly motivated and detail-oriented Regulatory Affairs – CMC professional with a strong background in radiopharmacy or radiopharmaceutical development. The successful candidate will support global regulatory strategy and execution for both marketed and development-stage radiopharmaceutical products involving PET and SPECT tracers. This is a cross-functional role requiring close collaboration with CMC, QA, manufacturing, and supply chain teams to ensure continued regulatory compliance and support for post-approval changes across global markets.

Job Description

Roles and Responsibilities

• To be the regulatory CMC strategy point of contact for project teams and to provide CMC related regulatory input for the assigned projects/products.
• Build, or provide input to, submission strategy documents by defining supplement type, data required to support submission, and submission documents required for the submission package.
• Guide the project team in the project planning phase so that the correct data (and level of detail) to suit the needs of all markets is collected and submitted.
• Author and review individual CMC submission documents/CMC dossier sections to support regulatory submissions.
• Provide consistent expert advice to the organization, determining feasible regulatory strategies and identify potential options, to assist in delivering optimal business value or mitigate compliance issues.
• Maintain registration tracking information and assist in the development of good document management practice standards.
• Work closely with global RA and, regional RA’s to address questions from regulatory authorities.

Required Qualifications

• Advanced degree in pharmacy, radiopharmacy, pharmaceutical sciences, chemistry, or related discipline (Doctor of Pharmacy (PharmD) or MSc in radiopharmacy preferred).
• Minimum 3 years of experience in Regulatory Affairs or Quality, with a track record of supporting marketed products and/or clinical development of radiopharmaceuticals.

Desired Characteristics

• Familiarity with PET production, automated synthesis (cassette-based systems), and GMP requirements for radiolabeled compounds.
• Experience with regulatory submissions for post-approval changes, including FDA supplements and EU variations.
• Ability to prioritize, plan & evaluate deliverables to established strategic goals for complex projects, including scientific discussions on how best to present information.