Director, Regulatory Affairs Advertising and Promotion
Crinetics Pharmaceuticals
10 hours ago
Remote friendly (United States)
United States
$200,000 - $240,000 USD yearly
Marketing
Position Summary
- Director, Regulatory Affairs Advertising and Promotion: Review and approve advertising, promotional, and medical communications for regulatory compliance. Regulatory reviewer for MLR and/or MRC teams supporting commercialization and marketed products.
Responsibilities
- Review medical education and commercial advertising/promotional materials (including disease-state and training/education programs) for compliance with applicable regulations/laws/guidelines.
- Serve as regulatory reviewer on MLR/MRC and other promotional review committees.
- Back-up contact for FDA Office of Prescription Drug Promotion (OPDP).
- Support 2253 submissions with Regulatory Operations.
- Monitor competitor advertising/promotion.
- Provide strategic input for compliant campaign communications aligned to program/corporate objectives.
- Identify MLR/MRC process/system improvements (e.g., Veeva).
- Communicate complex regulatory issues to project teams and external stakeholders.
- Implement strategies to keep programs within published guidance; identify risk areas.
- Assist with functional area budget management.
- Translate business needs into strategic initiatives and drive quantifiable outcomes (<2-year horizon).
- Develop external relationships (e.g., CROs/consultants), stay current on industry trends.
- Set high standards for deliverables; manage risks/timelines; train staff.
Required
- Bachelor’s or MS/PhD in a scientific area.
- 12+ years (BS) or 10+ years (MS/PhD) relevant Regulatory Affairs experience in biotech/pharma; 8+ years supervisory experience.
- FDA advertising/promotion regulations and guidance knowledge; MLR/promotional review committee experience.
- ICH and FDA regulations understanding.
- Strong negotiation, written/oral communication, organizational skills, ability to meet deadlines; Windows/MS Office; advanced MS Word and Adobe PDF knowledge.
Preferred
- Experience applying local regulations from early R&D through commercialization.
- Electronic document management (e.g., Veeva PromoMats) and eCTD/publishing knowledge (e.g., Lorenz, GlobalSubmit, eCTDExpress).
Benefits (as stated)
- Discretionary annual target bonus; stock options; ESPP; 401(k) match.
- Medical, dental, vision, basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.
- Director, Regulatory Affairs Advertising and Promotion: Review and approve advertising, promotional, and medical communications for regulatory compliance. Regulatory reviewer for MLR and/or MRC teams supporting commercialization and marketed products.
Responsibilities
- Review medical education and commercial advertising/promotional materials (including disease-state and training/education programs) for compliance with applicable regulations/laws/guidelines.
- Serve as regulatory reviewer on MLR/MRC and other promotional review committees.
- Back-up contact for FDA Office of Prescription Drug Promotion (OPDP).
- Support 2253 submissions with Regulatory Operations.
- Monitor competitor advertising/promotion.
- Provide strategic input for compliant campaign communications aligned to program/corporate objectives.
- Identify MLR/MRC process/system improvements (e.g., Veeva).
- Communicate complex regulatory issues to project teams and external stakeholders.
- Implement strategies to keep programs within published guidance; identify risk areas.
- Assist with functional area budget management.
- Translate business needs into strategic initiatives and drive quantifiable outcomes (<2-year horizon).
- Develop external relationships (e.g., CROs/consultants), stay current on industry trends.
- Set high standards for deliverables; manage risks/timelines; train staff.
Required
- Bachelor’s or MS/PhD in a scientific area.
- 12+ years (BS) or 10+ years (MS/PhD) relevant Regulatory Affairs experience in biotech/pharma; 8+ years supervisory experience.
- FDA advertising/promotion regulations and guidance knowledge; MLR/promotional review committee experience.
- ICH and FDA regulations understanding.
- Strong negotiation, written/oral communication, organizational skills, ability to meet deadlines; Windows/MS Office; advanced MS Word and Adobe PDF knowledge.
Preferred
- Experience applying local regulations from early R&D through commercialization.
- Electronic document management (e.g., Veeva PromoMats) and eCTD/publishing knowledge (e.g., Lorenz, GlobalSubmit, eCTDExpress).
Benefits (as stated)
- Discretionary annual target bonus; stock options; ESPP; 401(k) match.
- Medical, dental, vision, basic life insurance; 20 days PTO; 10 paid holidays; winter company shutdown.