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.  Strong problem solving and negotiation skills.                       
• Demonstrated experience of operating in a highly regulated environment. Capable of applying analytical skills in a CMC regulatory environment.
• Has experience working within a matrix organization and has strong interpersonal and influencing skills to work across disciplines. Has the capability to influence managers and help drive decisions at a project level.
• Demonstrated knowledge & experience in scientifically related field e.g. pharmaceutical sciences, chemistry and analytical sciences.
• Demonstrated strong ability in written and oral English in order to clearly and concisely  present information targeted to the relevant audience.
• Experience in pharmaceutical CMC regulatory or QA environment particularly with experience with injectable diagnostic or pharmaceutical products.  Ability to interpret global regulations and present to the wider business.
• Experience in electronic document management and Quality management systems.
• Ability to proactively champion projects & experienced in mentoring team members.
• Knowledge of international CMC regulatory requirements.
• Strong interpersonal skills and ability to engage effectively with colleagues at all levels.
• Prior regulatory agency interaction experience (e.g., query responses, scientific advice, deficiency letters).
• Experience of global regulatory affairs from the pharmaceutical and/or healthcare industry .
• Experience of regulatory project management and regulatory agency interactions.
• Experience with Veeva RIM or other registration tracking tools.
• Ability to work across cultures/countries/sites.
• Demonstrated experience of prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $132,000.00-$198,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions a