Vice President, Regulatory Affairs

Job Title: Vice President, Regulatory Affairs

Job Number: 83127

Location: , US

Job Description

Exciting opportunity for a Vice President, Regulatory Affairs to join the team. Reporting to the President, R&D, the VP will lead global regulatory strategies, prepare and submit briefing documents, INDs, CTAs, and marketing applications (BLAs/MAAs). Collaboration with Nonclinical, CMC, Quality, Clinical teams, and external partners is key.

Responsibilities

* Lead global regulatory efforts for innovative oncology therapies and manage a high-performing regulatory team. * Develop strategies to advance therapies from IND through pivotal studies and registration, and represent the company in regulatory meetings. * Oversee preparation and submission of global briefing documents and clinical trial applications; interact with health authorities. * Ensure adherence to global regulatory guidelines and collaborate with internal teams to meet deadlines and obtain approvals. * Monitor regulatory trends, adapt strategies, and implement processes suitable for company needs.

Required Skills

* Bachelor’s degree in life sciences or related field; advanced degree preferred. * 15+ years in biopharmaceuticals with 10+ years in Regulatory Affairs, ideally with oncology and precision medicine experience. * Experience with regulatory authorities and CTA/IND, BLA/MAA submissions. * Familiarity with CMC, Pharmacovigilance, and Quality matters in Regulatory Affairs. * Knowledge of drug development regulations (ICH, FDA, EMA) and excellent communication and regulatory writing skills. * Strong leadership, strategic thinking, and collaboration abilities. * Experience with drug development and regulatory requirements in various regions is a plus. * Detail-oriented, with the ability to work independently and in a fast-paced, team-oriented environment.#LI-DNI

Application Deadline: 2024-09-30