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Associate Manager/Manager, Regulatory Affairs CMC

Location: Whippany, New Jersey Salary: competitive
Sector: Pharma & Biotech Type: Contract

Title: Associate Manager/Manager, Regulatory Affairs CMC

Type: Contract

Duration: 6 Months (extendable)

Location: North Jersey

Rate: To be discussed....

My client, one of the top 5 pharmaceutical companies globally, is seeking a qualified Associate Manager OR Manager, Regulatory Affairs CMC, to join their GRA-CMC team. You will be responsible for providing strategic and some operational global Regulatory CMC direction, and documentation for projects/products covering development, registration and approval/post-approval activities.

Responsibilities:

  • Formulate and drive global CMC regulatory strategy for development projects or marketed products, conduct risk assessments and develop mitigation strategies.
  • Represent Global Regulatory Affairs CMC on interdisciplinary project teams and maintain sound working relationships with partners and customers.
  • Lead global CMC submission activities including change request evaluation, identifying required content to ensure compliance in meeting global regulatory requirements.
  • Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approval technical source documents in accordance with project time-lines.
  • Author and/or review CMC documentation for Health Authority submissions.
  • Possess knowledge on current regulatory guidelines and requirements in all global regions.

Requirements:

  • Degree in Science (Chemistry, Pharmacy, Biochemistry, Biology, Biotechnology) or equivalent required
  • 3 years of pharmaceutical industry experience in CMC drug development
  • 2-6 years of regulatory CMC experience
  • Working knowledge of global regulatory requirements

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