Director Regulatory Affairs, Advertising & Promotion - Pharmaceutical - San Francisco
Job Summary Leading biopharmaceutical company is looking for a REGULATORY AFFAIRS DIRECTOR, ADVERTISING & PROMOTION. This position is integral to assuring the Company’s commercial regulatory requirements and compliance with all applicable regulations and guidances. This position is responsible for decision-making, direction and oversight of commercial regulatory issues to meet internal and external customer needs.
Job Overview Company Overview
A leading biopharmaceutical company employing over 2,500 dedicated professionals covering all key markets around the world – including Europe, the US, Japan, China, Russia and Mexico. They are searching for breakthrough medicines for high unmet medical needs and this inspires and motivates all of us to work towards achieving our overriding mission: to treat more patients with groundbreaking therapies.
Essential Duties and Job Functions
• Provide commercial regulatory knowledge, consultation, advice and risk assessments to the US organization, including senior leadership, that are aligned with corporate commercialization efforts.
• Collaborate with SSF cross functional teams, Field Sales team, as well as global teams in creating and reviewing promotional materials to ensure compliance with related corporate and regulatory requirements while meeting strategic promotional objectives.
• Provide regulatory oversight and advice regarding advertisement and promotion materials (e.g. marketing materials, education materials, institutional promotion, disease education, press releases, websites, speaker presentations).
• Identify potential areas of regulatory compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provide general guidance on how to avoid or deal with similar situations in the future.
• Work with Regulatory Management Team in development of Commercial.
• Regulatory strategies, policies, cross-functional projects, and interdepartmental decision-making.
Skills Required • Bachelor's degree with at least 8 years biopharmaceutical industry experience, including at least 6 years in Regulatory Affairs; equivalent combination of advanced degree and less experience will be considered.
• Pharm D highly preferred
• Advanced scientific degree is desirable
• In-depth knowledge of advertising & promotion regulations, guidances, and enforcement actions.
• Demonstrated leadership, interpersonal and collaboration skills.
• Ability to resolve conflicts and interact effectively with management.
• Possess strong negotiation and decision making skills.
• Ability to develop creative solutions to complex problems.
Contact Details To discuss this opportunity further please contact Jack Keller at 628-225-1200 or by email at email@example.com Everything is 100% Confidential