Senior Manager, Regulatory Affairs

ProclinicalNew Jersey, USA

9 days ago

Job type

Permanent

Job description

Senior Manager, Regulatory Affairs - Permanent - New Jersey (REMOTE)

Proclinical is working alongside a biotech company seeking a Senior Manager to join their team.

Primary Responsibilities :

The successful candidate will lead global and regional regulatory strategies for late-stage development programs. This pivotal role involves shaping innovative therapies and navigating the complexities of global healthcare.

Skills & Requirements :

Bachelor's degree in a life sciences field (Biology, Chemistry, Pharmacy) required; advanced degrees are a plus.
Experience in regulatory affairs within the pharmaceutical or biotech industry, with a strong understanding of global and regional frameworks.
Ability to analyze complex scientific and regulatory data.
Strong organizational and multitasking abilities in a fast-paced setting.
Clear and concise communication skills to build alignment across teams.
Proactive, detail-oriented mindset, capable of thriving in both independent and team environments.

The Senior Manager, Regulatory Affairs' responsibilities will be :

Oversee the preparation and submission of regulatory applications such as INDs, CTAs, NDA / BLA, and MAA, ensuring compliance with global standards.

Develop and execute regulatory strategies that align with development and approval pathways.

Collaborate with clinical, safety, quality, and legal teams to achieve key program milestones.

Engage with regulatory agencies to support the advancement of innovative therapies.

Identify regulatory risks, propose solutions, and ensure seamless communication with senior management.

Contribute to continuous improvement initiatives, ensuring operational excellence and adherence to regulatory frameworks.