Senior Regulatory Consultant, CMC

Key People


Job ID :

11050


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


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 :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

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.

Responsibilities:
- 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 tbarratt@keypeople.co.uk


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

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 www.keypeople.co.uk.

View all Key People Jobs



© 2018 Jobsinpharma - 4ward Technologies Ltd All rights reserved.