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Job Details

Head of CMC Regulatory Affairs

Company: Advanced Clinical Recruitment Ltd
Location:
Reference: CMC- YK1
Closing Date: 31 Aug 17
Type: Full Time
Salary (£): 60,000 - 80,000
Benefits:

Job Summary:

The head of Chemistry, Manufacturing, and Controls (CMC ) Regulatory Affairs(RA) will play a pivotal role in the development, licensure, manufacturing, and ongoing marketing of pharmaceutical products at the company.

Requirements:

Job Summary:

The head of Chemistry, Manufacturing, and Controls (CMC ) Regulatory Affairs(RA) will play a pivotal role in the development, licensure, manufacturing, and ongoing marketing of pharmaceutical products at the company.

Requirements:

In this role, the head of CMC RA will work closely with other senior members of the business to ensure that pharmaceutical products are consistently effective, safe and of high quality for patients and consumers.
The head of CMC RA will ensure that an adaptive, regulatory strategy is created for each new chemical entity (NCE), that continuously and prospectively details the progressive, regulatory requirements from the initial FTIM clinical trial, throughout the pre-registration, registration, post-approval, and life cycle management of that compound.

Responsibilities will include but not be limited to:

• Managing all of the CMC Regulatory Affairs activities and requirements to achieve the
preparation of robust, regulatory submissions.
• Writing regulatory documents and serving as in-house regulatory expert to internal and external parties.
• Collaborates closely with multiple scientific, technical, quality, and commercial areas within the business and/or with external contract manufacturing organizations (CMOs), to help companies effectively and efficiently achieve regulatory approvals.
• Overseeing the development and formulation processes both internally and at CMO/CDMO manufacturing sites and providing relevant guidance and advice to expedite the manufacturing process while ensuring conditions for meeting regulatory requirements are maintained.
• Provides knowledge, understanding, interpretation and utilization of regulatory guidance’s and regulations, as well as industry and government agency best practices and trends.
• Responsible for obtaining FDA and EMA approval of new batches of ImmTAC in order to initiate clinical trials.
• Serve as a liaison between the business and regulatory agencies.

 

Apply for this job: Head of CMC Regulatory Affairs

Contact Information:

Address:  Head Office
Regus 2nd Floor
The Portergate
Eccleshall Road
Sheffield
S11 8NX
England
Tel:  0114 270 1741
Website:  Visit Our Web Site

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