Associate Director - Regulatory CMC

November 1

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Apellis Pharmaceuticals

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Targeted C3 Therapies • Complement System • Hematology • Ophthalmology • Nephrology

501 - 1000

Description

• We are looking for an Associate Director, Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC) to join our team. • This position will be responsible for developing and executing CMC regulatory strategies to support the expansion into international markets. • The Associate Director, primarily supports Rest of World (RoW) Regulatory CMC submissions for Apellis’s products, summarizes and applies international regulatory requirements, provides CMC regulatory input for Health Authority submissions. • Manage assigned regulatory projects and closely collaborate with personnel from Regulatory Operations, other scientific departments and external vendors to coordinate and implement submission strategy. • Planning, submission, and approval of applications and/or post-approval activities in collaboration with global partners. • Provide regulatory CMC expertise to cross-functional teams such as the Global Regulatory Project Teams, CMC Teams, Product Teams, etc. • Provide updates on strategic global regulatory intelligence, such as new CMC regulations, guidance, competitive product applications and approvals, etc. • Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents. • Coordinate team review and approval of submission document deliverables and attend review meetings. • Driving and coordinating preparation of meeting packages and response strategies to Health Authorities. • Work with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality. • Assist with logging, tracking and filing of correspondence with regulatory authorities. • Manage the regulatory assessments for all CMC control changes. • Perform other related duties as assigned.

Requirements

• Bachelor’s degree or equivalent in pharmaceutical (Biology, Chemistry, Pharmacy or related science, Engineering) and/or technical discipline. • Approximately 8 years of related pharmaceutical or biopharmaceutical industry experience with relevant technical experience (e.g. QA, Technical Services, Operations, Manufacturing or R&D), with at least 5 of those years directly in regulatory affairs. • Extensive knowledge of CMC regulatory requirements in international markets for both new and post approval (experience in LATAM, EU and GCC highly desirable). • Strong communication skills (e.g., clear and concise), team player, proven negotiation skills. • Strong time and project management skills • Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution. • Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. High energy, enthusiasm, and passion for the work. • Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.