Regulatory Affairs Manager - Next step for a specialist Generics experience need - - HOME BASED role
- Employer
- Mosaic Regulatory Solutions
- Location
- Home Based
- Salary
- Flexible
- Start date
- 21 Sep 2020
- Closing date
- 21 Oct 2020
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
Role: Regulatory Affairs Manager
Location: Home Based
Salary- Negotiable
This innovative company is a private, family owned, independent UK based generic company, wishes to recruit a Regulatory Affairs Manager to join their team, on a permanent full-time basis. Reporting to the Head of Regulatory Affairs, key responsibilities will include:
• Submission of UK and European Marketing Authorisation Applications, via all routes, managing deficiency responses and national phase requirements, in accordance with agency assessment timetables.
• Submission of Technical/Site Transfer Applications.
• Submission of post-approval applications, including, but not limited to, Type IA, Type IB, Type II, BSVs, Renewals and MAH Transfers/COAs.
• Dossier due-diligence and In-licensing project management.
• Provision of regulatory strategy, for a wide range of dosage forms, in line with current guidance/legislation, proving ability to implement strategies effectively and manage complex regulatory issues.
• Maintaining up-to-date knowledge of national and European guidelines/legislation, rectifying issues of non-compliance where required.
• Close liaison with various other departments, such as Technical/Quality, Medical Information and Pharmacovigilance, with a focus on anticipating and mitigating regulatory risks.
• Close liaison with commercial and launch management teams, to ensure prompt product launches and to maximize sales/market opportunities.
• Ensuring compliance with all internal regulatory processes, in readiness for both internal and external audits.
• Performance of other tasks or assignments, as delegated by the Head of Regulatory Affairs.
• A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget.
Ideally, the candidate will have a minimum of 7 years’ experience in Regulatory Affairs. Project Management experience is essential and experience in eCTD publishing would be an advantage.
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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.
- Website
- http://www.mosaicreg.co.uk/
- Telephone
- 07951 082482
- Location
-
Blackheath
London
SE3
GB
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