My client is a global clinical stage biopharmaceutical company founded by pediatricians and entrepreneurs who are dedicated to improving lives of patients with food allergies and other immunological diseases. They are seeking a Regulatory Advertising and Promotion Director or Sr. Director to lead the regulatory review for the launch of the company’s first product while supporting other regulatory functions. This is an exciting opportunity to get in at the ground floor of a company and make an immediate impact on their growth.
- Provide regulatory leadership and guidance to the marketing teams during the development, review and approval of advertising materials and product labeling.
- Assist in regulatory oversight related to advertising and promotional activities, working directly with the marketing teams from concept through review and approval, including submission to FDA.
- Serve as the FDA Liaison for matters related to Advertising and Promotion.
- Collaborate with the Vice President, Regulatory Affairs to execute US regulatory strategies ensuring that product development and are approvals consistent with corporate objectives and applicable regulations and guidelines.
- Support planning and execution of US submissions and responses to regulatory authorities related to INDs, amendments, aggregate reports, BLAs and supplements within company timelines and in accordance with regulations and guidelines.
- Interact and manage internal/external functional stakeholders effectively to gather data and develop documentation required for on-time submissions.
- Ensure that submission documents are accurate, compliant, and high-quality.
- Develop and maintain relationships with FDA review staff, and assist with the management/conduct of regulatory interactions with FDA.
- Monitor the regulatory landscape for competitive products and apply this knowledge to the development of products.
- BS in biochemistry, chemistry, biology, or related pharmaceutical fields required; advanced degree (PhD, PharmD, MS) strongly preferred.
- 10+ years of industry experience in pharmaceuticals, biotech and/or medical devices
- 5+ years regulatory affairs experience involving the direct implementation of Advertising, Promotions and Labeling
- Experience providing regulatory input and evaluation as part of a promotional review committee required.
- Experience working on a product launch highly desired.
- A proven track record of effective collaboration with the FDA including the OPDP.
- Excellent verbal and written communication skills.
- Experience in leading cross functional teams and working with peers, seniors and subordinates across different functional areas of the business required.
- Current knowledge of FDA guidelines and regulations with an emphasis on product promotional activities is essential.