The Associate Director, supports all CMC regulatory affairs activities for the company's products, summarizes regulatory requirements, provides CMC regulatory input for Health Authority submissions, and manages the compilation and review of CMC sections of all submissions for completeness and quality.
Provide strategic and tactical support for the timely preparation, editing and review of CMC sections, including regulatory agency meeting materials, IND/CTA amendments, original marketing applications and their respective amendments/supplements.
Manage assigned regulatory projects and closely collaborate with personnel from Regulatory Affairs, Regulatory Operations, Technical Operations, other scientific departments and external vendors to coordinate and implement submission strategy.
Provide updates on strategic global regulatory intelligence, such as new regulations, guidance, competitive product applications and approvals, etc. Apply to project specific regulatory CMC strategies, identifying scenarios for the earliest regulatory approvals possible and performing assessment of risk for each scenario.
Manage the quality, accuracy, compliance with internal and external standards, and the timely production of submission documents using manual and electronic document management systems, as appropriate.
Work with Regulatory Operations or publishing vendors to compile and review regulatory submissions for completeness and quality, ensuring that Apellis practices are in conformance with the latest health authority and industry submission standards.
Assist with logging, tracking and filing of correspondence with regulatory authorities and ensuring that all commitments are tracked and response timelines are met
Review documents in change control in order to ensure that they meet regulatory requirements.
Perform other related duties as assigned.
Bachelor's degree in a pharmaceutical (Biology, Chemistry, Pharmacy or related science, Engineering) and/or technical discipline.
10 plus 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 8 of those years directly in regulatory affairs.
Extensive knowledge of CMC regulatory requirements.
Proficient in pertinent software & tools.
Must be knowledgeable in industry trends for report and dossier preparation (e.g., IND/CTA/NDA/MAA, including electronic document submissions (i.e., eCTD).
Strong communication skills (e.g., clear and concise), team player, proven negotiation skills.
Ability to manage and motivate staff.
Strong understanding of pharmaceutical development.
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.
Able to take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance, as necessary.
Able to understand and interpret data/information and its practical application.
Apellis Pharmaceuticals, Inc.