Description: Our client is currently seeking a Director-Sr. Director Regulatory Affairs
The individual will have accountability for review and approval of promotional and medical communications of assigned brand(s). The Director of RA is responsible for leading interactions with the FDA Office of Product and Drug Promotion pertinent to assigned brand(s). The individual will be responsible for all submission types made to OPDP/FDA. The applicant's responsibility includes functioning as a leader during review meetings to assure compliance with and evolution of the Promotional Review Committee process enabling business needs to be met efficiently and effectively. Medical communications will be reviewed and approved at MRC in a similar process to PRC.
KEY ROLES AND RESPONSIBILITIES
Promotional Material Compliance and Strategy:
• Develop and execute regulatory strategies for the review and approval of promotional materials, including advertising and labeling materials for prescription drug products, to ensure alignment with FDA regulations and guidelines.
• Provide expert guidance on promotional labeling and advertising requirements, review processes, and potential risks associated with promotional claims.
Regulatory Submissions and Interactions:
• Oversee the preparation, review, and submission of promotional materials to the FDA OPDP, ensuring timely and accurate submissions.
• Act as the primary point of contact for FDA interactions related to promotional materials, including pre-submission meetings, advisory comment requests, and response to regulatory inquiries
Collaborate with marketing, medical affairs, legal, and compliance teams to ensure promotional materials are compliant with FDA regulations and company policies.
Provide training and guidance to internal stakeholders on FDA promotional material requirements and best practices.
Regulatory Compliance Oversight:
• Implement a robust monitoring and auditing program to ensure ongoing compliance with FDA regulations for promotional materials.
• Stay abreast of evolving FDA guidance and regulations related to promotional labeling and advertising and implement necessary changes to maintain compliance.
Regulatory Intelligence and Advocacy:
• Stay informed about industry trends, competitor activities, and FDA enforcement actions related to promotional materials, and communicate potential impact to senior management.
• Represent the company in relevant industry forums and participate in advocacy efforts to influence regulatory policies related to promotional materials.
Leadership and Team Management:
Lead a team of regulatory affairs professionals, providing guidance, coaching, and mentoring to facilitate their professional growth and success.
Foster a culture of compliance, accountability, and continuous improvement within the regulatory affairs team.
At least 10 years of progressively responsible experience in pharmaceutical regulatory affairs with a focus on FDA promotional material approval, preferably including experience in leading and managing regulatory affairs teams. In experience in biosimilars, immunology and oncology is a plus.
Strong understanding of pharmaceutical product development and commercialization, including clinical trial protocols, labeling requirements, and product lifecycle management.
Excellent communication and interpersonal skills, with the ability to effectively interact with internal stakeholders, regulatory authorities, and industry peers.
Strong leadership and team-building capabilities, with the ability to motivate and develop team members.
This job and many more are available through The Judge Group. Find us on the web at www.judge.com