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Regulatory Affairs Consultant - Part remote role / Buckinghamshire - European full MAA work

Employer
Mosaic Regulatory Solutions
Location
Buckinghamshire
Salary
Flexible
Start date
9 Feb 2021
Closing date
11 Mar 2021

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Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Senior / Consultant - Regulatory Affairs - Global Consultancy- Friendly environment- Perm role - Buckinghamshire / Part remote working

Key duties

You are a source of expertise in the registration and post-licensing activities of pharmaceutical products or other health products.

Registration (e.g. coordination of EU procedures, responses to questions, experience with export countries)

Post MAA (e.g. preparation and submission of variations, advice on classification and documentation required, MA holder transfers, renewals, PSUSA)

Supports the regulatory local launch activities at global level and early access program (set up the regulatory launch strategy, coordinates local partners, compiles local requirements).

Global regulatory promotional materials review & validation: reviews and validates promotional materials from a regulatory point of view as per EFPIA/IFPIA guidelines, coordinates partners

Writing of regulatory documents

Interaction with agencies and partners

Conducts due diligence on the regulatory part of dossier/company

If possible, you are also experienced in development and regulatory strategy (e.g. scientific Advice, ODD, PIP, CTA)

You ensure high quality and on time delivery to clients to maintain client satisfaction.

Education and experience

• A least 7 to 10 years’ experience in the pharmaceutical industry, broadly based Regulatory Affairs experience, including a successful track record in the registration and maintenance of pharmaceutical products within Europe and/or at export.

 

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Company

Mosaic Regulatory Solutions is a specialist recruitment consultancy founded in 2002. Set up to meet the ever increasing demand for regulatory professionals in a market place with a growing skills gap.

Our expertise lies solely in regulatory affairs recruitment. And as such we have a real understanding of this sector. As this is our technical specialty we remain industry leading and preferred supplier of choice to a number of clients and first port of call for many regulatory affairs professionals.

We understand team / environmental “fit” is vital so continue to find the right career and environment to suit all candidates.

Listening to client needs, we respond with a professional, seamless and pro-active style of recruitment.

Mosaic work with an ever growing client base with the UK and Europe. We are dedicated to providing long term relationships with clients and candidates. We are proud that a high percentage of our business is repeat business.

Company info
Website
Telephone
07951 082482
Location
Blackheath
London
SE3
GB

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