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About the role
Key responsibilities & impact- Develop and implement Chemistry, Manufacturing and Control regulatory strategies for assigned pharmaceutical products
- Prepare and review information for regulatory CMC dossiers for commercial products
- Lead global product and project regulatory strategies by identifying requirements and evaluating supporting documentation
- Lead development, authoring, and review of CMC submission components for approval supplements/variations, Drug Master Files, NDA/BLA/MAA submissions, Annual Reports, Commitments, and responses to health authority questions
- Liaise with global CMC teams, Manufacturing Division, and Contract Manufacturing Organizations
- Support compliant change management execution
- Assess and communicate regulatory risks and propose mitigation strategies
- Deliver regulatory milestones across the product lifecycle
- Collaborate with regulatory agencies and global stakeholders to support compliant medical products
Requirements
What you’ll need- Bachelor's in science, Engineering, or a related field; advanced degree preferred but not required
- At least 5 years pharmaceutical industry experience preferred, or up to 3 years' experience managing Chemistry, Manufacturing and Control Regulatory submissions for small molecules, vaccines, or biologics
- Experience in Veeva preferred
- Experience reviewing scientific information and assessing technical merits and scientific rationale
- Understanding of manufacturing, analytical testing, and quality assurance
- Proficient computer skills and experience operating electronic document-based GMP systems, including Veeva
- Oral and written communication skills
- Ability to generate innovative solutions and work with key stakeholders
- Ability to respond flexibly to changing priorities and unexpected events
- Ability to handle multiple priorities and achieve business goals
- Effective leadership, communication, and interpersonal skills
- Knowledge of BLA, eCTD, international regulatory compliance, pharmaceutical process development, regulatory affairs management, regulatory CMC, regulatory strategy development, regulatory submissions, regulatory writing, and technical writing
- US and Puerto Rico residency required
- No visa sponsorship
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement