• Full Time (Salaried)
  • ,

Company:  Confidential

Job Title: Dir./Sr. Dir. of Regulatory Affairs

Job Number: 34385

Location:

Job Description

An exciting new opportunity is available to join a growing regulatory team as a Director/Senior Director of Regulatory Affairs, reporting directly to the Chief Regulatory Officer. This individual will hold a crucial role within the organization, developing and overseeing regulatory strategies and compliance to ensure the successful development, registration, and commercialization of products.

Responsibilities

  • Develop regulatory strategies for product development.
  • Offer expertise in clinical research and compliance.
  • Collaborate with teams for global filings.
  • Support development management in strategy planning.
  • Provide regulatory advice in project meetings.
  • Ensure compliance with local and international regulations.
  • Advise project teams on regulatory matters.
  • Fulfill additional duties as needed.

Required Skills

  • Bachelor’s degree in Biological Sciences, Pharmacy, or related field required; Advanced degree/certificate in regulatory affairs preferred.
  • 8-10+ years regulatory experience in pharmaceutical or biotech industry required.
  • Oncology experience preferred.
  • Strong knowledge of US drug development and regulatory requirements.
  • Proficiency with regulatory tools and databases.
  • Excellent time management and project coordination skills.
  • Support health authority inspections and readiness.
  • Effective communication skills for collaboration and representation.

 

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