Working with a unique platform our client is dedicated to bringing forward new therapeutic approaches for patients with rare and complex diseases.
You will play a crucial role in US and ROW Regulatory strategy, reporting into an extremely experienced GRL. There is huge opportunity for learning and development in this position. The goal for this person is to move into a GRL role as soon as possible.
You will be working with a unique platform across a range of therapeutic areas, including programs for Covid-19.
Strategic Leadership & External Interactions - 85%
• In partnership with others and under the direction of the GRL, develops and implements innovative regulatory strategies in close collaboration with relevant business units and Commercial functions to obtain, maintain and extend product registrations in the United States. This includes establishment and maintenance of regulatory strategy plans in close coordination with the the BU CMC Regulatory Affairs and EU Regulatory Strategy functions and the Payer Value and Patient Access function.
• Serves as a US and International regulatory strategy subject matter expert for assigned projects. Serves as a US and International regulatory strategy subject matter expert for assigned projects. Provides proactive guidance to BU and R&D internal functions based on technical and regulatory knowledge. Proactively identifies, assesses and mitigates regulatory risks associated with product development and maintenance for assigned projects.
• Participates in Global Regulatory Team and represents BU regulatory affairs function on select internal program teams.
• Assists in the coordination of cross-functional group of regulatory professionals as part of the Global Regulatory Team, including but not limited to RA CMC, RA Operations, Labeling, EU RA, Device RA, Advertising/Promotion and RA Intel/Policy to drive global regulatory strategies.
• Drives the tactical implementation of strategic regulatory plans for the creation and submission of regulatory documents, e.g., INDs, NDAs/BLAs, supplemental NDAs/BLAs, CTAs, Marketing Applications, and other relevant regulatory filings.
• Develops and implements US regulatory strategies to obtain and maintain INDs and NDAs/BLAs, and to extend product registrations.
• Coordinates and supports the design and implementation of international regulatory strategies to obtain, maintain and to extend product registrations internationally.
• Drives the creation of high quality, compliant regulatory documents within defined timelines as per BU objectives.
• May serve as direct liaison to the US FDA. Provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities, including Japan, Canada, EEA and growth and emerging markets (GEM).
• Acts as a point of contact and interface with key BU R&D functions in the preparation, review and approval of regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved Therapies in the US and internationally.
• Remains knowledgeable about current regulations and guidances and interprets the regulatory environment to provide proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical regulatory plans. Proactively identifies and assesses regulatory and compliance risks associated with product development and life-cycle management activities.
• Proactively develops and fosters appropriate relationships with regulatory agencies, especially the US Food and Drug Administration, to develop effective, professional relationships and advance a positive company image.
• In partnership with other relevant functions, assists in the conduct of regulatory agency inspections and compliance audits. Helps ensure compliance in all GRA BU activities.
• Acts as an ambassador for the BU Regulatory Affairs organization to influence and shape the external regulatory and policy environment.
BU R&D Leadership - 10%
• Serves as an active member of the BU Regulatory Affairs team to help influence the operations and future strategy of the BU R&D and Global Regulatory Affairs organization.
• Works in a highly matrixed, GPT-oriented environment and ensures close collaboration with other BU functions and relevant R&D functions to provide an effective, common approach and partnership centrally, regionally, and locally.
• Supports International Regulatory Affairs activities as directed.
Culture and People Leadership - 5%
• Actively contributes to a culture of transparency, innovation and teamwork. Is approachable to colleagues across the organization and is open to the ideas of others.
Education and Experience Requirements
• Minimum of 3 years of experience in drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities with at least 1 year of experience in a Regulatory Affairs role.
• Experience in plasma-derived therapies, biologics, drug safety, pharmacovigilance and/or risk management preferred.
• US and International regulatory affairs and global regulatory or health policy experience preferable.
• Bachelor’s or Master’s degree required. Advanced scientific or health sciences degree or equivalent relevant experience preferred.