Regulatory Affairs Director

1 week ago

United PA USA, United States Fairway Consulting Group Full time

At Fairway Consulting Group, we are seeking a highly skilled Regulatory Affairs Director to join our team. This key role will be responsible for leading the development and implementation of regulatory strategies for our clients' pharmaceutical and medical device combination products.

Key Responsibilities:

  • Develop and execute regulatory strategies to ensure compliance with local, regional, national, and international regulations.
  • Lead planning, organization, and conduct of formal meetings/teleconferences with regulatory agencies.
  • Oversee the organization and compilation of regulatory submissions and other correspondence.
  • Ensure compliance with internal SOPs and regulatory laws, standards, and regulations.
  • Collaborate with cross-functional departments to drive meetings and meet each program's critical regulatory milestones.

Requirements:

  • A bachelor's degree in life science or a related discipline is required; an advanced degree is preferred.
  • Minimum of 8 years of prior pharmaceutical/biotechnology industry experience, including at least 6 years in regulatory affairs.
  • Experience in vaccine and/or oncology development is strongly preferred.
  • Must have expertise in US regulations with direct experience in successfully interacting with the FDA with global regulatory expertise preferred.
  • Proven experience preparing INDs, CTAs, BLAs, NDAs, MAAs, and health authority meeting briefing documents.

What We Offer:

  • Opportunity to work with a leading life sciences search firm.
  • Collaborative and dynamic work environment.
  • Competitive compensation and benefits package.

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