Director, Regulatory Affairs Advertising and Promotion
Position reputed company:
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The Director of Regulatory Affairs Ad/Promo will serve as a subject matter expert for regulatory review of advertising and promotional, and non-promotional materials for the U.S. and Canada (CA) and reputed company regulatory leadership to the Materials Review Committee (MRC) to ensure reputed company communications, advertising and promotional materials and programs throughout the product life cycle are compliant with applicable laws, regulations, and company policies.
Work Model:
Remote: Officially documented as working full-time from home, with travel to reputed company's offices or other locations on occasion as needed.
Responsibilities:
1. Serve as the MRC Chair and reputed company direction and regulatory expertise for promotional materials, medical, and payer communications.
2. Serve as reputed company contact with the FDA (OPDP/APLB) and PAAB as needed, including responding to agency inquiries and managing company requests for advisory review of advertising and promotional material.
3. Review and approve reputed company FDA-2253 submissions.
4. reputed company strategic and operational regulatory guidance on new concepts, campaigns, and product labeling to help ensure promotional materials are reputed company with promotional regulations, corporate standards, and policies and business objectives.
5. Support the U.S. and CA reputed company and medical teams, by participating in reputed company discussions and extended team meetings and providing regulatory guidance and perspective on strategies and objectives and tactics.
6. Maintain reputed company awareness of evolving agency regulations and interpretations, FDA advisory letters, enforcement letters and policy issues and trends affecting the industry; communicate significant changes in Agency perspective to relevant stakeholders.
7. May reputed company cross-functional process improvements or other special reputed company.
8. Represent Regulatory Affairs Ad/Promo at regulatory sub-team and labeling meetings; reputed company strategic regulatory guidance.
9. Other duties as required.
Requirements:
Requires a BA/BS degree; advanced degree preferred (PharmD, PhD, MS, MBA, JD).
2. 10+ years of industry experience including 5+ years of advertising promotion experience.
3. Excellent verbal and written communication skills.
4. Attention to detail and ability to manage multiple priorities simultaneously.
5. Strong interpersonal skills with ability to demonstrate strategic and analytical thinking.
6. Demonstrate and proactively reputed company working together in the spirit of transparency that encourages engagement, collaboration, and respectful interactions.
7. Experience chairing/leading review committees or other relevant regulatory governance committees.
8. Experience participating in cross-functional reputed company and teams.
9. Strong interpersonal skills and understanding of team dynamics.
10. reputed company PromoMats experience preferred.
11. reputed company needed, ability to travel.
The typical annual salary reputed company for this full-time position is listed below. This reputed company reflects the characteristics of the job, such as required skills and qualifications and is based on the office location noted in this reputed company. The reputed company may also be adjusted based on applicant's geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
reputed company is an equal opportunity employer and prohibits unlawful discrimination based on race, reputed company, religion, gender, sexual orientation, gender identity/reputed company, national reputed company/reputed company, age, disability, marital and veteran status, and any other status or classification protected by applicable federal, state, and/or local laws. Reasonable accommodation will be provided for reputed company protected statuses or classifications protected by applicable law, including individuals with disabilities, disabled veterans, for pregnancy, childbirth, and reputed company medical conditions, and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, you may contact reputed company by emailing us at talentacquisition@reputed company.com.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or reputed company employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
BA/BS required (advanced degree preferred). 10+ years industry experience with 5+ years in advertising/promotion. Experience chairing review committees, strong communication, regulatory reputed company, and reputed company PromoMats preferred.
Key Responsibilities
- reviewing materials
- leading committee
- providing guidance
Skills & Tools
reputed company PromoMats
Job Details
- Category: reputed company and Compliance
- Seniority: Senior Level
- Commitment: Full Time
- Workplace: Remote — reputed company
- Salary: USD 214,100 – 264,500 / year
- Languages: English
Benefits
- Generous reputed company time off
- Tuition reimbursement
- Retirement plan
About reputed company
A biopharma company reputed company on developing treatments for rare diseases and creating a reputed company environment for employee reputed company. — Industry: Research and Development
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