CMC Regulatory Manager

Regulatory CMC Manager

Location: East Anglia- commutable from Essex, Hertfordshire, Sussex

Salary: Competitive - dependant on experience

Role:

* Team of CMC product development and regulatory experts in global drug development with API and drug product expertise in the synthesis of both drugs, biologics and vaccines for development into finished dosage forms
* * Team of regulatory experts highly experienced in development of product milestone dossiers, excellence in navigating regulatory environment, requirements, Agency interactions, processes and submissions for successful regulatory review outcomes
* * Knowledgeable about strategic approaches to fast track a product into Phase I trials and also development of

commercial image registration ready dosage forms for NDA and MAA filings

1. Advise clients on strategic regulatory considerations for CMC product development, provide scientific product development services (API, formulation, analytical, clinical manufacturing and CMC program management); contribute to efforts directed at product competitive benchmarking, i.e. review of relevant regulatory precedents for evolving products and new molecule types and their likely basis of CMC approval.

2. Author and critically review CMC portions of regulatory dossiers.

3. Mentor Lab customer facing teams on product development and regulatory requirements for successful approvals,

4. Active engagement in Business Development activities with GMP labs BD reps and lead scientists to offer full CMC product development capabilities, RFP/ Bid defense to win business - Alliance and comprehensive product development projects, Collaborative and Stand-alone Projects. Assist labs in winning higher value specialized CMC work (biosimilars, vaccines, comparators, etc).

Duties and Responsibilities:
* * Prepare regulatory submissions
* * Review and provide technical advice to prepare regulatory submissions
* * Provide regulatory strategy advice to internal and external clients
* * Provide project specific GRA strategy, technical expertise and co-ordination oversight for key client's projects
* * Ensure quality performance for key/managed projects

If you are interested in finding out more infomation cotnact or call 02077587311 and ask for Natalie Hopkins

To find out more about Real Staffing please visit www.realstaffing.com