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Regulatory Affairs Strategist (Pharmaceuticals)

Title: Regulatory Strategist

Location: New Jersey

Duration: 12 Months (Contract-to-Hire)

Start Date: ASAP

Overview:

The position is to provide Regulatory Affairs strategic support for the company's novel drug development programs. The individual will work with the lead Regulatory Strategist and extended development teams for executing the overall regulatory strategy, which includes handling all regulatory submissions, document preparation and team meeting minutes.

Responsibilities:

  • Support Regulatory Strategist for assigned investigations and approved small molecule and/or biologics.
  • Work with Regulatory team to insure supported development programs are compliant with ICH regulatory requirements and all local country regulatory requirements.
  • Strong project management skills and strong interpersonal skills to handle complex distributed programs.
  • Experience in authoring clear and concise regulatory documents, including cover letters, regulatory forms, dossier components and other regulatory documents.
  • Work closely with Regulatory CMC Lead and overall development team to insure overall regulatory strategy and regulatory CMC strategy are aligned.

Mandatory Requirements:

  • Bachelor's degree in Chemistry, Biochemistry, Pharmacy, Bio-medical Engineering OR Chemical Engineering.
  • 3-5 years within Regulatory Affairs
  • 5 years within the industry

Required Skills:

  • Understanding of ICH and US CFR requirements and regulations
  • Regulatory document submissions authoring experience (INDs, IMPDs, NDAs, BLAs and briefing books)
  • Supported Regulatory Agency interactions, either through attendance, leadership or preparation
  • Strong communication skills

Sthree US is acting as an Employment Business in relation to this vacancy.