Sr. Regulatory Affairs Specialist (Advertising & Promotional Material Review)
Sr. Regulatory Affairs Specialist (Advertising & Promotional Material Review)
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Job Description
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race color creed religion ancestry age sex marital status national origin disability or veteran status.
Why youll love working atAxogen:
- Friendly openandfunteam culturethat values uniqueperspectives
- Company-wide dedicationto profoundly impacting patients lives
- Comprehensive high-quality benefitspackage effective on date of hire
- Educationalassistanceavailable for all employees
- Matching 401(k)retirementplan
- Paid holidaysincluding floating holidaysto be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions we will guide and expect the market and design requirement specifications underlying our engineering business development and clinical research activities objectively target advancements in standards of care.
Job Summary of the Sr. Regulatory Affairs Specialist
The Sr. Regulatory Affairs Specialist (Advertising & Promotional Material Review) leads the end-to-end review process for promotional and non-promotional content across Axogens portfolio of brands with a specific focus on the Avance Nerve Graft product line. This role is pivotal in ensuring an efficient and compliant review of all advertising and promotional material while adhering to regulatory standards company policies and legal requirements. The incumbent will ensure that all materials comply with Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) and Office of Prescription Drug Promotion (OPDP) and internal regulatory requirements while fostering a culture of collaboration and compliance.
Requirements of the Sr. Regulatory Affairs Specialist
- 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 of the Sr. Regulatory Affairs Specialist
The specific duties of the Sr. Regulatory Affairs Specialist include but are not limited to:
- 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 andStandard 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.
Location
111 West Oak Ave. Tampa FL 33602
OR
13631 Progress Blvd. Alachua FL 32615
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Benefits/Compensation
This position is eligible for an annual bonus.
Benefits offered for this position include Health Dental Vision Matching 401K Paid Time Off 9 Paid Holidays 3 Floating Holidays Dependent Care Flexible Spending Accounts Medical Flexible Spending Accounts Tuition Reimbursement Paid Parental Leave Paid Caregiver Leave Basic Life Insurance Supplemental Life Insurance Employee Stock Purchase Plan and Disability Insurance as described in more detail in summary plan descriptions.
Axogen follows healthcare system guidelines with respect to credentialing vaccinations and other employment/compliance related requirements as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.
Required Experience:
Senior IC
Employment Type
Full Time
