Job Description
Position Summary
The Senior Regulatory Affairs Specialist (Advertising & Promotional Review) leads the end-to-end review process for promotional and non-promotional content across Stallergenes Greer portfolio of products. This role is also responsible for supporting product submissions, license renewals, and periodic updates to regulatory agencies across North America.
Position Responsibilities
- Oversee the review and approval process for advertising, promotional, sales training, and promotional labeling materials, ensuring compliance with all regulatory requirements.
- Ensures all materials comply with Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and Office of Prescription Drug Promotion (OPDP), and other regulatory requirements while fostering a culture of collaboration and compliance.
- Assist Regulatory Affairs team with submission to CBER upon Medical, Legal, and Regulatory (MLR) Committee approval.
- 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.
- Supports content for regulatory submissions for US FDA, USDA and Health Canada.
- Supports development of strategies and responses to government agency inquiries.
- Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions with other members of Regulatory Affairs and related teams.
- Interprets applicable regulations and policies and works with cross-functional teams and management to ensure compliance.
- Identifies the need for new or modified regulatory procedures and participates in their development and implementation.
- Monitors regulations and policies and communicates them to the company.
- Other tasks, as required.
Education
- Bachelor’s degree in physical/biological sciences preferred.
Experience and Knowledge
- 3 - 5 years’ experience in biopharmaceutical and/or medical device Regulatory Affairs, with specifically 1+ year in advertising and promotional review.
- In-depth knowledge of pharmaceutical, biologics, and/or medical device regulations.
- Must have supported, authored, or reviewed regulatory submissions in the U.S. and/or Canada.
- Proven experience working with Veeva PromoMats and supporting submissions to CBER/OPDP.
- Ability to actively seek out relevant legislation and competitive information on product lines.
- Demonstrated ability to collaborate and think innovatively.
- Ability to prioritize and manage several projects and deadlines concurrently.
- Must be self-motivated and have the ability to take ownership of her/his responsibilities.
- Excellent written and verbal communication skills.
Certificates, Licenses, Registrations
- Regulatory Affairs Certification (RAC) preferred.
Job Tags
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