Regulatory Affairs Manager

• Anticipate and develop strategies and/or contingency plans for CMC-related scenarios in the areas of biologic/small molecule drug substances, drug products, and drug-device combination products.
• Determine regulatory and scientific/technical requirements for CMC and GMP-related submissions and inquiries.
• Represents CMC RA in project team meetings and provides regulatory guidance and perspective to the cross-functional team in conjunction with global regulatory lead(s).
• Prepare, coordinate and/or review all CMC and GMP-related documents for submission to regulatory authorities to assure compliance with regulatory, company standards and scientific/technical requirements.
• Independently manage the preparation of INDs, BLAs, CTAs, amendments, supplements, and aggregate reports within company timelines and in accordance with regulations and guidelines.
• Provide regulatory assessment in change management.
• Develop and maintain collaborative relationships with other local and/or global functional units [OPCJ CMC RA, Factory, Quality, MPDD, OPDC/OPEL Tech Ops] as well as affiliates, external partner companies, contract manufacturers, packagers and suppliers etc..
• Participate in Health Authority CMC meeting preparations, rehearsals, and/or meetings.
• Assess and develop innovative ideas to optimize local and global CMC RA departmental processes and improve efficiencies, addressing current and future challenges.
• Be proficient in the tools and systems needed for the function including and not limited to CREDO (doc management), ORIOM (regulatory information), Track Wise, Concur (expenses), and PowerPoint.
• Performs other duties as assigned.

Requirements:

• 5-7 years of CMC regulatory experience in the pharmaceutical industry with a history of success in investigational filings and approvals of marketing applications as the CMC Regulatory lead.
• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes, GMP, and related issues.
• Knowledge of CMC regulatory requirements for biologics and small molecules during development and post-approval, including biologic upstream and downstream processes, analytical methods, and drug/device combination products.
• Comprehensive knowledge and experience in preparing CMC (Quality) sections for investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions .
• Comprehensive understanding of the global regulatory environment.