Global global specialty-driven biotech/pharma company, focused on innovation and specialty care. A workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across many therapeutic diseases areas. Empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.
The Vice President, Regulatory Affairs will have oversight of all regulatory and quality assurance activities to support company’s marketed products in the US and North America (incl. Canada) and for leading the team involved in such activities.
- Primary responsibilities to ensure efficient and compliant functioning of all promotional review for company marketed products, and to insure all regulatory reporting requirements such as expedited safety reports and PSURs, are completed and filed on time.
- Responsible for managing and evolving the Promotional Review Committee and Medical Review committee processes to ensure that the business needs are met efficiently and effectively. In addition, this individual is responsible for regulatory support of Phase IV studies being conducted the US affiliate.
- Requires interaction with Global Regulatory Affairs, North American Safety, US Medical Affairs, US Legal Affairs and Compliance and commercial functions for the purpose of providing regulatory insight during promotional plan development and implementation to ensure conformity with FDA expectations and requirements.
- Responsible for leading all interactions with the FDA Office of Product and Drug Promotion and coordinating as necessary with the FDA therapeutic divisions.
- Works with cross-functional areas to determine the appropriate strategy for labels for regulatory authority review and approval and, after approval, for maintaining labeling documents.
- Provide expert input into promotional regulatory strategies to ensure compliance with FDA guidance’s on advertising and promotion while meeting business needs.
- Collaborate with company physicians and cross-functional project teams to design and implement high quality regulatory strategies.
- Participate in the development of US affiliate clinical plans to ensure protocol design, endpoint are consistent with US quality and clinical trials requirements.
- Build strong relationship with FDA (OPDP) and act either individually or through a delegate as the primary FDA OPDP regulatory on matters related to advertising and promotion.
- Communicate regulatory status to executive management.
- Create or develop SOPs or working instructions to ensure consistent high quality regulatory affairs function.
- Develop team members to grow to meet company business needs in a best-in-class way.
- Complies with all laws, regulations and policies that govern the conduct of U.S. staff.
- Manage a team of employees and contractors from Regulatory Affairs Associate level to Director/Senior Director level.
- BS, MS and/or Advanced degree in a scientific discipline
- Minimum 15 years experience in the biotech/pharmaceutical industry
- Minimum of 10 years in Regulatory Affairs
- Management and supervisory experience with at least 5 years in the pharmaceutical industry managing a group
- Proven biologics or specialty pharmaceuticals experience
- Experience with peptides or proteins and toxins plus
- Experience in Oncology a plus
- Expert current knowledge of regulations and drug development guidelines with some technical experience in aspects of drug development
- Solid experience with promotional review, working with Division in FDA responsible for advertising and promotion
- Recognized as leader, yet team player, with cross-functional collaborative skill sets.
- The ability to manage multiple activities or projects
up to $360K+ plus Annual Bonus + LTI (Long Term Incentive)
Greater Boston, MA