Insmed is a biopharmaceutical company dedicated to improving the lives of patients battling serious lung diseases. We are focused on the development and commercialization of novel, targeted inhaled therapies for patients with high unmet needs battling orphan lung diseases. Insmed is a sustainable, patient-centered biopharmaceutical company at the intersection of Pulmonary, Orphan and Infectious Diseases.
Insmed understands that its most valuable resource is its employees. We place great value on the unique skills, talents and qualities that each of our employees brings to our company. We are building a world-class team with a focus on innovation, teamwork and the desire and ability to change the way our patients live.
Insmed is a fast-paced, high-energy organization that seeks talented individuals who are leaders in their respective functional areas of expertise, who are creative problem solvers and who have the desire to make a difference.
Insmed has established three Review Committees (Commercial, Medical and Publications). The Director, Regulatory Affairs will serve as a regulatory reviewer on all 3 committees and chair the Commercial Committee. In this capacity, the Director will be the Regulatory participant working within cross-functional teams with representation from Medical, Legal and Compliance as necessary.
- Represent Regulatory Affairs on Insmed’s 3 Review Committees (Commercial, Medical and Publications) providing regulatory review and direction assuring communications of all aspects of regulations, and risk mitigation strategies
- Chair the Commercial Review Committee (CRC) which will focus on the review and approval of typical Pharmaceutical Advertising & Promotional materials, including but not limited to, Sales Aids, Booth materials, Websites (drug specific, LinkedIn, Corporate), commercial aspects of disease awareness, concepts reviews, commercial training modules
- Provide regulatory review and direction to the Global Publications Review (GPR) committee including focusing on R&D and Medical manuscripts, abstracts, and posters
- Provide regulatory review and direction to the Medical/Clinical Review Committee including focusing on medical slide decks, MSL support documents/tools, medical booth materials and medical standard response letters
- Oversee/prepare the content of US FDA 2253 submissions, assuring compliance and on time filing
- Prepare responses to requests received from FDA regarding drug advertising and promotion for review by Regulatory Affairs product lead and Senior Management in Regulatory; provide support for similar process for ex-US inquiries from Heath Authorities
- Reviews current policies/practices and guidelines issued by Federal regulatory agencies and update management as needed
- Maintains a thorough understanding of FDA’s OPDP requirements, as well as a keen awareness of enforcement trends
The ideal candidate will possess a Bachelor’s degree in scientific discipline (advanced degree is a plus) and a minimum of 7 years relevant work experience in Regulatory Affairs aspects of promotional materials review. He/She must have experience with all aspects of a Promotional Review Committee process as well as experience interfacing with multiple departments to provide regulatory review and product label assessment as it relates to risk mitigation specifically related to product promotional aspects. The incumbent must have detailed expertise in global and especially FDA’s OPDP requirements, as well as a keen awareness of enforcement trends. Excellent communication (verbal and written), negotiation, and organization skills and a strong attention to detail, clarity, accuracy and conciseness are key for this role.