Associate Director - Regulatory CMC

4 days ago

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Apellis Pharmaceuticals

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

501 - 1000

Description

• Responsible for developing and executing CMC regulatory strategies to support international market expansion. • Manage assigned regulatory projects and collaborate with Regulatory Operations and external vendors. • Provide regulatory CMC expertise to cross-functional teams and manage global regulatory intelligence. • Manage submission documents and coordinate team review and approval. • Liaise and negotiate with global regulatory authorities, ensuring compliance with standards. • 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.