|Location: Maidenhead, Berkshire||Salary: £60 - £68 per hour|
|Sector: Regulatory Affairs||Type: Contract|
|Contact: Sam Davies||Job Published: 22 days ago|
Regulatory Affairs Consultant
Regulatory Affairs Consultant needed for a multinational Pharmaceutical organisation based in Maidenhead who are looking to employ a Regulatory Affairs Consultant with an in-depth knowledge of Global compliance and the Pharma industry.
The successful Regulatory Affairs Consultant will want to work for this client not just because it's a great opportunity but also because they will give you will receive a pay rate of up to £68.00 per hour.
Some of the main duties of the Regulatory Affairs Consultant will include:
* 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
This really is a fantastic opportunity for a Regulatory Affairs Consultant to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!
This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for interview.