Vice President/Senior Vice President Regulatory Affairs in New Jersey

Global Life Science Hub is partnered with an innovative biopharmaceutical company specializing in difficult-to-formulate biologics in the Oncology and Infectious Disease fields. Recently, the company has achieved 2 FDA approvals and is now transitioning from R&D to a full-scale commercial organization. With a highly robust pipeline of advanced assets and expected approvals lined up until 2030, the company is positioned for significant growth.

As the new SVP of Regulatory Affairs, the successful candidate will lead the regulatory team in developing and implementing global regulatory strategies for the company's pipeline products as they expand beyond the USA. The ideal applicant should have a successful record in registering biologics and biosimilars and be able to commute to New Jersey on a 25% basis.

Responsibilities

• Develop global regulatory strategies to gain earliest possible regulatory approval in US and other international markets...