Apellis Pharmaceuticals · 1 day ago
Associate Director, Regulatory CMC (International)
United States
Internship
Remote
Intern, Senior Level, Lead/Staff
8+ years exp
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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.
Qualification
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Required
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.
Company
Apellis Pharmaceuticals
Apellis Pharmaceuticals focuses on developing novel therapeutics and drug delivery technologies to address chronic inflammatory diseases.
501-1,000 employees
H1B Sponsorship
Apellis Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (5)
2022 (6)
2021 (9)
2020 (2)
Funding
Current Stage
Public CompanyTotal Funding
$643.53MKey Investors
Sixth StreetSectoral Asset ManagementCormorant Asset Management
2024-05-14Post Ipo Debt· $475M
2020-01-01Post Ipo Equity· undefined
2017-11-09IPO· undefined
Leadership Team
Cedric Francois
Co-founder, Chief Executive Officer , and President
Adam Townsend
COO
Recent News
Company data provided by crunchbase
