Senior Regulatory Consultant, CMC

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,--West London,West London,

Key Skills :

regulatory, CMC, contractor, contract, OTC, consumer, regulatory affairs, module 3

Salary :

£45 - £68 per hour

Date Posted :

07 Apr, 2018

Company Name :

Key People

Location1 :

West London

Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



An excellent opportunity has become available for an experienced CMC professional to join an OTC team within a global pharmaceutical company on an initial 12 month contract basis.

- Partner with R&D, QA, Operations, Business Units and others to develop regulatory strategies for submissions and product related activities.
- Identify and negotiate delivery of documentation for CMC submissions.
- Write high-quality CMC documents during development and product registration, contribute to CMC regulatory strategies, assure technical congruency and regulatory compliance by meeting agreed submission deadlines.
- Preparation, review, submission, approval and maintenance of CMC sections for regulatory filings (MAA's, variations, renewals, etc.)
- Review post-approval changes (change controls) and assess the regulatory impact on affected registrations. Develop regulatory strategies and coordinate filings (e.g. Variations, Responses to Questions), as appropriate.
- Work collaboratively with global CMC colleagues and, as required, provide leadership to and supervision of CMC support colleagues.
- Work with R&D leaders to refine/develop processes relating to regulatory submissions and regulatory aspects of product development and maintenance.
- Train and educate colleagues with respect to regulatory requirements.
- Assess compliance of product (formulations, manufacturing processes, packaging, specifications, etc.) with filings and propose CMC mitigation strategies.
- Keep knowledge up to date with regard to quality guidelines and technical trends

For further details, please contact Tim Barratt on +44(0)1727 817 626 or send a copy of your CV to

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit

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