Title: Associate Manager/Manager, Regulatory Affairs CMC
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.
- 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.
- 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.