Regulatory Affairs Manager IV

Role Description

Provide CMC regulatory strategy input and expertise in the area of investigational, new and marketed biologic and small molecule drug products to assigned project teams, to ensure products are developed/maintained in compliance with global regulatory requirements and guidance. Primary regions/markets of responsibility include US and secondarily EU and Canada for smooth, timely approvals or continued marketing.

Responsibilities Include:

• 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), TrackWise, Concur (expenses), and PowerPoint.
• Performs other duties as assigned.

Qualifications & Experience:

• 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 for Europe and Canada
• Comprehensive understanding of the global regulatory environment.

Education:

• Bachelors in Pharmaceutical Sciences or Chemistry or Pharm.D., Masters and Ph.D. preferably majoring in Pharmaceutics, Biochemistry, Molecular Biology, Biotechnology or Biology
• RAC certification is a plus

Term:

• 12 month contract, option to extend
• Remote
• Healthcare Benefits available
• 401k