Associate Director, Regulatory Affairs, CMC

Role Overview

• 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

Requirements

• 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
• 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

Benefits

• medical, dental, vision
• paid time off
• a 401(k) plan with employee and company contribution opportunities
• life, disability, and accident insurance
• tuition reimbursement