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Senior Associate, Regulatory Affairs

Berkshire   •  Negotiable  •  Permanent, Full time


Job Title: Senior Associate, Regulatory Affairs

Location: Reading

Salary: 45,000 - 55,000 plus package

This is an exciting opportunity for a Senior Associate, Regulatory Affairs to join one of the worlds leadings healthcare companies, who have a strong global presence and a broad innovative product portfolio.

This role will be aligned to their speciality division which includes products within Oncology, Rare Diseases, Neurology and more. As a Senior Associate you will be responsible for submitting registrations across UK and EU markets and ensuring MAA's are obtained and maintained in line with strategy.

Responsibilities:

- Prepare and managing MAA's to be submitted to regulatory authorities via national, MRP, DCP and CP

- Interact with regulatory authorities on enquiries and deficiencies

- Managing post licensing and lifecycle management activities

- Support technical review and preparation of high quality regulatory submissions to authorities

- Provide support in the preparation, distribution and follow up of registration documentation required for UK and Ireland

Experience:

Life sciences or chemistry degree or equivalent professional qualification or proven relevant experience within the regulatory environment.

Additional experience in the pharmaceutical industry or a related field desirable

Proven familiarity with the pharmaceutical research and development process with ability to critically review and integrate scientific information from a variety of disciplines.

Ability to work across a variety of therapeutic areas with new and/or established medicines with the capability to represent Regulatory at brand meetings, with support from management.

A comprehensive understanding of EU regulatory procedures for marketing authorisations and submission to regulatory authorities

Significant post-licencing experience with an understanding of lifecycle maintenance for pharmaceutical products, including variations and renewals

An awareness of post-Brexit procedural routes to UK national marketing authorisation

Experience with submission of CMC changes to licences, with an ability to review CMC information and advise on it

Knowledge/understanding of ABPI and IPHA code, promotional and non-promotional materials and PI

Knowledge and understanding of procedures for notifying Health Authorities (UK/IE) in case of out of stock

Understanding of the Common Technical Document (CTD) and pharmaceutical dossier structure

Familiarity with electronic submission platforms and electronic publishing

For more details please apply with your updated CV and I will be in touch to discuss this further.

chris.bart@cpl.com

  • Agency: Cpl Life Sciences
  • Reference: JO-2207-497748
  • Posted: 26th July 2022
  • Expires: 23rd August 2022

Cpl Life Sciences

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