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Job Details

Global CMC Regulatory Affairs Manager - Midlands

Company: Mosaic Regulatory Solutions
Location: Midlands
Reference: 773372
Closing Date: 08 Jul 18
Type: Permanent
Salary (£): On Application
Benefits: Excellent

Job Summary:

To apply for this CMC Regulatory Affairs Manager please call Julie Cooper on 07951 082482 to discuss this role. Alternatively please send your CV to:


Role- Global CMC Regulatory Affairs Manager - will consider project managers

Location- Midlands

Salary - On application

The RoleThis is a fantastic opportunity to join our growing Regulatory Affairs team as a CMC Manager, Regulatory Affairs. In this role you will be responsible for providing CMC regulatory leadership and strategy across the organisation and to our global customer base across EU and US territories.Responsibilities Include

Responsible for line management and potential global growth of the CMC Regulatory Group.

Provide expert advice, strategy and guidance to functional groups and sponsors as required on regulatory CMC aspects of programmes.

Develop excellent relationships with internal global functional groups and sponsors.

Author and review CMC content of dossiers to ensure it is complete, well-written, and meets all relevant regulatory requirements.

Proactively manage CMC aspects of multiple programmes including overseeing preparation and submission of CMC dossiers, in conjunction with other Quotient Regulatory functions.

Work with Quotient Sciences functional groups and sponsors to resolve often complex CMC issues.

Support CMC interactions and response to questions with EU agencies and FDA to ensure acceptance, and approval of regulatory CMC packages in support of clinical trials, marketing applications, variations, and other submissions which present CMC information.

Keep abreast of changes in the CMC regulatory environment, by researching and interpreting regulations to provide regulatory guidance to, Manufacturing, Analytical and other relevant functional groups.

Ensure continued management, development and process improvement of CMC related activities within the organisation in response to agency feedback or changes in the regulatory environment.

The CandidateThe successful candidate must have B.Sc life sciences degree in pharmaceutical science, chemistry, or similar, as well as a minimum of 5 years CMC focused regulatory affairs experience within the pharmaceutical industry or CMO.Other Essential Skills And Experiences Required

Sound knowledge, understanding, interpretation and utilisation of EU and US CMC regulatory framework. A good working knowledge of other territories such as Japan, China and India would also be an advantage.

Experience within drug development and in the authoring/review of CMC related documentation such as IMPD, IND and MAA/NDA.

Experience of analysing and interpreting global regulations and scientific publications and using this information to solve complex CMC Regulatory issues.

Experience of technical writing and review of CMC documentation.

Ability to convey and present complex information to others clearly and logically.

Demonstrate strong project management skills including planning, prioritisation, problem solving, decision making and adherence to strict deadlines.

Ability to work independently and manage their own workload.

Ability to work effectively on a number of projects simultaneously.

Ability to work to a high quality standard and possess a high level of attention to detail.

Be a good team player with ability to build strong and constructive relationships both throughout the company and externally.

Possess a strong customer focus.

Possess excellent written and verbal communication skills.

Have a working knowledge of GMP.

Have previous experience of line management.

Be willing to travel within the UK and US.

Applicants must have the right to work in the UK upon being offered employment.Company BenefitsIn return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.

Key words /key word:

regulatry affairs, reg affairs , regulatory . regulatory manager , CMC , Midlands

Apply for this job: Global CMC Regulatory Affairs Manager - Midlands

Contact Information:

Address:  Mosaic Regulatory Solutions Ltd
Tel:  0208 305 9733
Website:  Visit Our Web Site

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