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Regulatory Affairs Manager - Consumer / Generics / Post approval / CMC / UK / Ireland Licence work

Employer
Mosaic Regulatory Solutions
Location
West Midlands
Salary
Flexible
Start date
30 May 2024
Closing date
29 Jun 2024

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Role- Regulatory Affairs Manager

 

Location West Midlands and Remote working

 

Salary - On Application

 

Management, review and submission of all post-approval applications required to support the portfolio – including, but not limited to, Type IA, IB & II Variations, BSVs, Renewals, MAH Transfers/COAs, Sunset Clause Notifications/exemptions and MA withdrawals.

 

Management, review and submission of Site Transfer Applications.

 

Where necessary, submission of UK Marketing Authorisation Applications and managing deficiency responses, in accordance with agency assessment timetables.

 

Provision of regulatory strategy for projects, in line with current guidance/legislation, implementing strategies effectively and managing complex regulatory issues.

 

Maintenance of up-to-date knowledge of UK guidelines/legislation, rectifying issues of non-compliance where required.

 

Close liaison with various other departments such as Quality, 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.

 

Management and support of projects for the out-licensing of  products, ensuring all regulatory information is provided and support is provided throughout the ongoing MAAs.

 

Liaison, where required, with regulatory authorities, in order to progress relevant  MAAs, variation procedures and all other applications.

 

Compilation / update of departmental Standard Operating Procedures (SOPs).

 

Creation / input into change controls which have a regulatory impact.

 

Managing, mentoring and training of any junior Regulatory direct reports, including the setting of annual KPIs and performance.

 

Liaison with external service providers/consultants related to Regulatory activity.

 

To manage product specific communication with drug safety provider, to ensure PV & MI reporting requirements are maintained.

 

Management of all internal departmental databases/trackers.

 

Performance of other tasks or assignments as delegated by the Head of Regulatory Affairs.

 

Ability to multi-task and demonstrate diplomacy.

 

Proficient (excellent) in English verbal and written communication skills to convey and receive ideas and instructions to/from others within and outside the organisation

 

Ability to effectively present information and respond to questions from peers, management, suppliers and customers

 

Team work

 

Strong organizational skills

 

Proficient skills in Microsoft Office applications (Word, Excel, PowerPoint, Access)

 

Ability to work effectively under pressure to meet deadlines

 

Minimum of 5 years working in a Regulatory Affairs function.

 

Life science degree.

 

Wide ranging and up to date technical/quality knowledge and experience within the pharmaceutical industry.

 

A good track record with the MHRA or EU agencies.

 

Substantial previous experience within a GMP environment.

 

Project management experience.

 

Excellent scientific and technical knowledge.

 

 

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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