Stallergenes Greer U.S.
Senior Regulatory Affairs Specialist
Stallergenes Greer U.S., Lenoir, North Carolina, United States, 28645
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.
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.
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.
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.
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.