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Regulatory Affairs Manager

Central London   •  £55 - 75 per hour  •  Permanent, Full time

Regulatory Affairs Manager

Pay rate - 55-75

12 Month Contract

Remote work

Main Accountabilities

Preparation and submission of the following:

- MA variation and renewal applications

- Change of ownership applications

Update of SmPCs and associated product labelling in line with local and regional requirements.

Creation, assessment and approval of artwork texts and mock-ups.

Management of Company and third party own label supplier compliance

Management of allocated workload and completion of monthly status reporting.

Provision of regulatory support for strategic commercial opportunities, technical projects and lifecycle maintenance activities.

Assessment of CMC regulatory data requirements and development of regulatory submission strategies considering both compliance and commercial needs.

Regulatory lead in the raising and assessment of local change controls.

Provision of regulatory support for business development opportunities.

Conduct of MA cancellations.

Sunset Clause monitoring and reporting.

Working in accordance with Global and local Working Instructions and SOPs.

Maintenance of Manufacturing, Import and Wholesale Dealers authorisations.

Maintenance of Active Substance authorisations required under the Falsified Medicines Directive.

Maintenance of regulatory archives

The processing and clear communication of regulatory approvals to internal and external stakeholders.

Provision of regulatory support for internal and external audits.

Carrying out other activities that contribute to the effective performance of the Regulatory Affairs Department.

Key Performance indicators

Ability to manage workload whilst maintaining quality and compliance in a fast paced environment

Consistent maintenance of system files in accordance with local and global operating procedures to ensure compliance

Efficient and clear communication with internal and external stakeholders

Proactive participation in other activities which contribute to the effective performance of the Regulatory Affairs Department

On-time, accurate filing of variation submissions and subsequent approvals

Development of regulatory strategies considering compliance requirements and commercial impact

Maintenance of high quality registration files resulting in no recalls due to non-compliance

100% compliance with KPIs set within objectives

Successful outcomes in internal and external audits

If you think this role is the role for you, please apply within or send your CV to mark.bathe@cpl.com

  • Agency: Cpl Life Sciences
  • Contact: Mark Bathe
  • Reference: JO-2111-480535
  • Posted: 19th November 2021
  • Expires: 17th December 2021

Cpl Life Sciences

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