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Regulatory Affairs Manager

4 months ago

West Midlands, United Kingdom Mosaic Regulatory Solutions Full time

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.