Sr. Regulatory Affairs Specialist – Advertising & Promotional Material Review
| Company | Axogen |
|---|---|
| Location | Tampa, FL, USA, Alachua, FL, USA |
| Salary | $89604 – $112006 |
| Type | Full-Time |
| Degrees | Master’s |
| Experience Level | Senior |
Requirements
- Advanced degree in life sciences, regulatory affairs or a related field preferred.
- 1+ years’ experience in Regulatory Affairs, specifically in advertising and promotion within the pharmaceutical or biologics industry.
- Proven experience working with Veeva PromoMats and supporting submissions to CBER/OPDP.
- Working knowledge of regulatory compliance requirements (FDA regulations and OPDP/CBER guidelines).
- Strong understanding of the advertising and promotional regulatory landscape.
- Excellent communication and interpersonal skills, with an ability to build relationships across various stakeholders.
- Demonstrated problem-solving skills and the ability to develop creative solutions while managing regulatory risks.
- Experience in working with cross-functional teams and projects.
- Strong organizational skills with the ability to prioritize tasks effectively.
Responsibilities
- Oversee the review and approval process for advertising, promotional, sales training, and promotional labeling materials, ensuring compliance with all regulatory requirements.
- Assist Regulatory Affairs team with submission to CBER upon Medical, Legal, and Regulatory (MLR) Committee approval.
- Serve as a Subject Matter Expert (SME) on Veeva PromoMats, providing technical guidance and best practices to colleagues regarding material submission and compliance.
- Manage end-to-end workflows within Veeva PromoMats, including metadata validation, reviewer assignment, tier classification, and final sign-off processes.
- Schedule and facilitate live MLR review meetings, summarizing discussions, aligning stakeholders, and ensuring timely reviews, including agenda planning and management of expedited reviews.
- Track and follow up on reviewer feedback, outstanding action items, and next steps to ensure timely resolution.
- Communicate material status updates to relevant stakeholders regularly.
- Support and participate in brand and tactical planning meetings to anticipate upcoming review needs and ensure alignment with business objectives.
- Continuously assess, enhance, and maintain the Ad Promo Review process and Standard Operating Procedures (SOPs) to improve efficiency, effectiveness, and compliance with regulatory guidelines.
- Train employees on the promotional material review process.
- Identify bottlenecks and inefficiencies in the review workflow, streamlining operations, and minimizing material rejections.
- Track key performance indicators (KPIs) such as review turnaround times and submission quality, implementing improvements as needed.
- Act as a mentor and coach to cross-functional team members, providing guidance on regulatory requirements and best practices.
- Serve as a neutral facilitator in review discussions, fostering solutions-based problem-solving to address challenges.
- Collaborate with cross-functional teams to identify and resolve any issues in the review process.
- Perform other duties and responsibilities as requested or assigned to support the overall success of the team and the business.
Preferred Qualifications
- Advanced degree in life sciences, regulatory affairs or a related field preferred.