Senior Regulatory Affairs Manager, Chemistry Manufacturing and Controls
About The Position
The Senior Regulatory Manager provides chemistry, manufacturing, and controls (CMC) regulatory input and strategies to support development projects and marketed products within Pharmaceutical Diagnostics. The role develops and maintains the Quality sections of product dossiers throughout the product life cycle, including Module 2.3 and Module 3. The position provides strategic CMC regulatory guidance, supports submission planning and preparation, and works with project teams and global and regional regulatory affairs colleagues to address regulatory authority questions. It also supports quality assurance during audits and inspections and keeps current with CMC-related guidelines.
Requirements
- Bachelor's degree and at least 6 years of experience.
- Experience in the diagnostic, pharmaceutical, or medical device industry.
- Ability to prioritize, plan, and evaluate deliverables against established strategic goals.
- Demonstrated experience working in a highly regulated environment and applying analytical skills in a CMC regulatory environment.
- Demonstrated knowledge and experience in a scientifically related field, such as pharmaceutical sciences, chemistry, or analytical sciences.
- Experience with electronic document management and Quality Management Systems.
- Knowledge of international CMC regulatory requirements.
Nice To Haves
- Master's degree.
- Experience in pharmaceutical CMC regulatory affairs or a Quality Assurance environment, particularly with injectable diagnostic or pharmaceutical products.
- Experience working in a matrix organization, with strong interpersonal and influencing skills across disciplines and the ability to influence managers and drive project-level decisions.
- Experience with Veeva RIM or other registration tracking tools.
- Demonstrated ability to prioritize conflicting demands from multiple business entities in a fast-paced environment.
- Strong problem-solving and negotiation skills.
Responsibilities
- Provide CMC-related strategic regulatory input for assigned projects and products.
- Build or contribute to submission strategy documents by defining variation type, supporting data requirements, and required submission documents; review and approve published output.
- Work with the Global Regulatory Lead to guide project planning and ensure the appropriate data and level of detail are collected and submitted for all markets.
- Review, write, and edit CMC submission documents and dossier sections as needed.
- Maintain registration tracking information and assist in developing good document management practice standards.
- Work with global and regional Regulatory Affairs teams to address questions from regulatory authorities.
- Provide proactive CMC regulatory advice and assess the impact of key brand CMC variations on product dossiers; advise project teams accordingly.
- Support Quality Assurance during audits and inspections as required.
- Stay updated on CMC-related guidelines.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Paid time off
- 401(k) plan with employee and company contribution opportunities
- Life insurance
- Disability insurance
- Accident insurance
- Tuition reimbursement
- Professional development
- Performance-based incentive compensation, which may include cash bonuses and/or long-term incentives
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What This Job Offers
Job Type
Full-time
Career Level
Senior
