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Senior Broadcast Support Engineer Job at NBA in Paramus

NBA
Paramus, NJ Full Time
POSTED ON 2/12/2025
AVAILABLE BEFORE 5/12/2025

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.

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