Senior Manager, Regulatory Affairs
Independently implements and leads Area regulatory strategies and priorities in conjunction with Area regulatory management and collaborates with Global Regulatory Affairs colleagues as appropriate. Identifies and obtains data needed and ensures they are effectively presented for submissions to Health Authorities. Manages Area regulatory submission and approval process. Serve as area point of contact with Health Authorities for routine communications in support of filings. Ensures application of established policies and best practice regulatory standards within Area regulatory for all filings, maintenance of existing product registrations and Health Authority interactions. Position may also include championing and/or coordinating business or operational strategic regulatory projects across GRS therapeutic areas. This will include supporting Regulatory Affairs Leadership needs relating to initiatives and business activities with an aim to increase operational efficiency.
Key Responsibilities Include:
Key Responsibilities Include:
- Assesses Research and Development programs against Area specific regulatory requirements. Responsible for influencing internal customers on Area regulatory issues including commercial, public affairs, clinical development, legal, and others who contribute to regulated communication or communications that could be regulated.
- Represents Area regulatory on subteams as appropriate. Advises on Area-specific requirements and provides strategic input.
- Serves as Health Authority point of contact and interface for meetings, teleconferences, etc. Coordinates preparation of Health Authority meeting briefing packages. Begins developing effective relationships with Health Authorities.
- Manages and leads the preparation and review of regulatory submissions consistent with Area regulatory requirements and guidelines and assures complete and timely responses to Health Authorities during application review.
- Assures the established policies and standard interpretation of regulations are communicated and followed for assigned projects. Provides regulatory direction regarding marketed products and products in development to support the development of compliant and competitive promotional programs.
- Responsible for creating and implementing a strategic approach to regulatory compliance for company communication strategies for drug and biological products.
- Provides support to RA Leadership Team as required for business activities and other strategic initiatives across TAs, as needed.
- Bachelor's or advanced degree in pharmacy, biology, chemistry, pharmacology or related life sciences is required.
- At least 5 years experience required in Regulatory, R&D, or related area with minimum of 3 years experience preferred in pharmaceutical regulatory activities.
- Experience interfacing with government regulatory agencies and proven skill at implementing successful global regulatory strategies.
- Experience working in a complex and matrix environment is required.
Equal Opportunity Employer Minorities/Women/Veterans/Disabled