POSITION SUMMARY:

We are looking for an Associate Director, Regulatory Affairs CMC to join our team. We are expanding our existing group of exceptionally talented and well-motivated colleagues to develop and commercialize
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, summarize and apply international regulatory requirements, provides CMC regulatory input for Health Authority submissions, manages the compilation and review of CMC M3 sections for completeness and quality. Manage post approval changes for ROW countries.

QUALIFICATIONS

• 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.

PRIMARY RESPONSIBILITIES:

• 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.
• Provide regulatory intelligence to project specific regulatory CMC strategies, including scenarios for the earliest regulatory approvals possible as well as an assessment of risk for each of the various scenarios.
• 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.
• 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, and for liaising and negotiating with global regulatory authorities.
• 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 no commitment remains unduly outstanding.
• Manges the regulatory assessments for all CMC control changes.
• Perform other related duties as assigned.

OTHER DUTIES:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

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