about 1 month ago
Role: Associate Director/Director/Senior Director Regulatory Promotion Review/Labeling
Full Time Opportunity
Fully Remote or Office Based in Maryland
Report to Senior Vice President, Regulatory Affairs. Function as Labeling and Promotional Review Lead and oversee regulatory labeling and promotional material review. The offer level will depend on the candidate’s relevant experience.
- Construct Company Core Datasheet, and draft and reviewing labeling for investigational studies, marketing authorization submission collaborating with medical, commercial and other functions
- Responsible for managing vendors as appropriate in drafting labelings and other materials
- Be a core member in Communication Committee and Promotional Review committee. Responsible for reviewing all public disclosed information, including promotional material, scientific exchange, manuscript, conference presentation, press release, non-promotional material; ensure the material comply with FDA and other health authorities’ requirement and company policies and achieve business goals
- Critically review and provide detailed comments and solutions to promotional strategies and tactics to ensure balance of the messages and appropriateness of the content of the materials/activities for regulatory compliance
- Effectively partner with Clinical, Medical Affairs, Legal/Compliance, Marketing and other departments as needed to ensure the thorough, timely and efficient review of all materials
- Be the interface with commercial and Medical Affair team to support global product planning and launch
- Interpret and communicate FDA current guidance to relevant stakeholders and recommend policy and/or process changes enterprise wise as needed Other responsibilities might be assigned according to business need.
- BS in Sciences required; advanced degree highly preferred
- Must have 8+ years of pharmaceutical or biotech industry experience
- Must have 5+ years of hands-on experience functioning as regulatory promotion reviewer
- Must have experience working with medical drug’s labeling
- Must have functioned as a member in Promotional Review Committee;
- Must demonstrates thorough understanding of regulatory review of promotional materials
- Must have a thorough understanding with relevant FDA guidances on labeling and promotion on medical drugs.