Responsibilities
- Represents Regulatory Affairs as a member of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials
- Maintain a deep and current awareness of evolving US and global regulations, Codes and guidelines, enforcement actions and policy issues affecting the pharmaceutical/biotech Industry as it pertains to labeling and promotion
- Effectively partner and collaborates with Medical Affairs, Legal, Compliance, Commercial, and other stakeholders as needed to ensure that promotional and non-promotional materials are reviewed in a timely fashion throughout the product life cycle
- Primary Liaison with OPDP and effectively manages relationships with FDA contacts
- Provide strategic regulatory advice for labeling taking into consideration marketing use post-approval
- Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management
- Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities
Requirements
- Doctorate, Master's, or Bachelor's degree in a relevant/scientific discipline (graduate degree preferred)
- Minimum of eight years working in the pharmaceutical or biotech industry with a minimum of 10-15 years in Regulatory Affairs
- Experience working with OPDP
- Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion
- Ability to work in a fast-paced environment where drive is critical to success
- Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions in order to reach resolution
- Strong writing, project management and communication skills
- Ability to travel as needed (2x a month) to our New Haven, CT office
Nice to Have
- Knowledge of global drug/biologic regulations and standards particularly related to promotion including but not limited to EU and international Requirements is a plus
Work Arrangement
Hybrid
Additional Information
- Ability to travel as needed (2x a month) to our New Haven, CT office
