Manager, Regulatory Affairs CMC
The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) combines scientific, regulatory & business issues to enable products that are developed, manufactured or distributed to meet required legislation. Provides support for the regulatory department to ensure efficient & compliant business processes & environment. Develops & manages content strategy for regulatory submissions, including new market applications, supplements & variations. Prepares CMC regulatory strategies that enable first pass approvals under management supervision; builds & maintains relationships within the regulatory affairs functional areas, Operations & Research & Development (R&D). Manages products & change control in compliance with regulations, company policies & procedures. Serves as liaison with FDA. Represents CMC regulatory affairs on teams such as the product development & Operations brand teams to negotiate, influence & provide strategic advice.
Key Responsibilities Include :
Key Responsibilities Include :
- Identifies and collects data needed and prepares CMC regulatory product strategies under limited supervision. Seeks expert advice and technical support as required for strategies and submissions.
- Prepares regulatory applications, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision.
- Manages products and change control in compliance with regulations and company policies and procedures. Analyzes and approves manufacturing change requests.
- Develops strategies for CMC meetings, manage preparation for agency meetings and manages content of pre-meeting submissions.
- Regularly informs regulatory management of important timely issues.
- Trains, develops and mentors individuals; may include formal supervisory responsibilities.
- Develops and implements policies and procedures within the regulatory affairs department.
- Analyzes legislation, regulation and guidance and provides analysis to the organization.
- Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions.
- Supports combination products and medical devices including design control and change management activities
- Required Education: Bachelor's degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject.
- Preferred Education: Relevant advanced degree preferred.
- Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management.
- Experience working in a complex and matrix environment.
- Strong communication skills, both oral and written.
- Preferred Experience: 5 years' experience in Discovery, R&D, or Manufacturing. 5 years' experience in Regulatory Affairs (pharmaceutical/medical device/combination product).
- Note: Higher education may compensate for years of experience
Equal Opportunity Employer Minorities/Women/Veterans/Disabled