Senior/Vice President, Global Regulatory Affairs – Remote, US East Coast
Global Life Science Hub is partnered with an innovative biopharmaceutical company dedicated to developing novel medicines to address unmet medical needs. With multiple FDA approvals and a focus on various therapeutic areas, including oncology, and infectious diseases, this company has made significant strides in developing both small molecule and biological drug candidates.
As the company transitions into a full commercial organization, they seek a Vice President of Regulatory Affairs to take the reins from its retiring predecessor. The ideal candidate for this critical leadership position will have a strong background in regulatory affairs and a proven track record of success in developing and registering biologics and biosimilars, with experience in both small and large molecules.
As the new SVP of Regulatory Affairs, the successful candidate will be able to lead the regulatory team in developing and implementing global regulatory strategies for the company’s pipeline products. They will work closely with regulatory agencies, build and manage a high-performing team, and ensure compliance with all regulatory requirements and guidelines. This is an exciting opportunity to join a growing organization and make a meaningful impact on developing life-saving medicines.
- Develop and implement global regulatory strategies for the company’s pipeline products
- Lead interactions with regulatory agencies (e.g., FDA, EMA) to ensure successful development and registration of pipeline products
- Build and manage a high-performing regulatory affairs team
- Manage regulatory submissions, including INDs, BLAs, NDAs, and MAAs, specifically related to the company’s pipeline products
- Ensure compliance with all regulatory requirements, guidelines, and standards related to the company’s pipeline products
- Stay abreast of regulatory developments and assess their impact on the company’s pipeline products and business
- Work cross-functionally with other departments to ensure alignment on regulatory strategy and timelines for the company’s pipeline products
- Represent the company at industry meetings and conferences related to the company’s pipeline products
- Bachelor’s degree in life sciences or related field, advanced degree preferred
- 15+ years of regulatory affairs experience, with a focus on biologics and biosimilars is highly preferable
- Experience leading and managing regulatory affairs teams
- In-depth knowledge of global regulatory requirements and guidelines for drug development and registration, specifically related to the company’s pipeline products
- Proven track record of successfully developing and registering biologics and biosimilars, specifically related to the company’s pipeline products
- Excellent communication and interpersonal skills, with the ability to work effectively with internal and external stakeholders
- Strong leadership and management skills
The Global Life Science Hub are a niche Life Science headhunting firm. We place professionals across Europe and the US for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations.
If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies – www.glshub.com