Contract Position – Associate Director Regulatory Advertising & Promotion Consultant

Consulting Position – Remote – Long Term

Our client is one of the world’s premier biopharmaceutical companies. With a commitment to science, medicine, research, and development focused on patients’ needs and unmet challenges. In this role, you will lead Regulatory Affairs initiatives to ensure all promotional items are prepared and executed in accordance with applicable regulations and guidelines and company policy. This is a 6-month engagement, 40 hours a week.

Job Summary:

• Oversees regulatory guidance provided by team to ensure compliance with promotional regulations.
• Responsible for Global Processes and applications of codes and regulations for Global review of products.
• Oversight/Accountable for all submissions within group.
• Approve enforcement responses.
• Manages personnel within group to ensure coverage for brand and therapeutic area responsibilities.
• Understand and interpret complex scientific issues related to regulatory requirements and promotional strategy. Able to mentor and develop skills of staff.
• Understands broad concepts within regulatory affairs and implications across organization.
• Offers creative solutions and strategies, including risk mitigation strategies.
• Develops strategy for efficient and appropriate OPDP review and play a key role in life cycle management strategy.
• Reviews competitive materials and interacts with FDA to urge enforcement activity as necessary.
• Responsible for development and training of global review processes.
• Works closely with Medical, Legal, OEC, Marketing, Marketing Operations, Sales, and Sales Training departments as well as external advertising agencies and consultants in the successful development of promotional and applicable training materials.
• Support development and maintenance of product labeling with Regulatory Affairs Labeling and Strategy groups.
• Lead for Promotion and Advertising Regulatory Review for licensing opportunities

Qualifications:

• BS/BSc preferred; BA accepted, PharmD preferred.
• 8 years industry with 6 years regulatory or related experience.
• Previous experience in Regulatory Affairs promotion and advertising; experience in managing major regulatory filing(s) e.g. Launch Advisory Materials or responses to enforcement letters.
• Prior people management experience not required but preferred.
• Extensive knowledge of applicable FDA regulations.
• Able to provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for the development of marketing materials.
• Understands regulatory, quality, and safety systems impacting drug development and marketed product support.
• Functions independently as a decision-maker on regulatory issues.

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