• We use cookies to help make our website work. LEARN MORE

Regulatory Affairs Associate

Cheshire   •  Contract/Temporary, Part time


CK Group are recruiting for a Regulatory Affairs Associate to join a company in the Pharmaceutical industry at their site based in Macclesfield on a contract basis for 12 months.

This is a part time role, working 4 days per week.

Salary:
£130 Per day PAYE

Regulatory Affairs Associate Role:
? Input regulatory knowledge, intelligence & information into relevant systems and databases maintaining data accuracy and up to date information for the group and relevant databases and platforms.
? Maintain documentation & records management in EDMS (ie, Veeva Vault or ANGEL) in accordance with defined standards & process and as requested by RAMs & Global Regulatory Execution teams (GRETs) eg. support with Submission Ready standards/Housestyle skills & QA checks, specific authoring tasks, liaison with Regulatory Operations
? Support the product registration and maintenance of designated product applications in accordance with standards of regulatory compliance
? Provide support across the group for assigned non-drug project roles & responsibilities, eg. as a designated point of contact for external partner, provide specific technical expertise.
? Be the interface with HA/HA systems for designated regulatory tasks, eg. co-ordination & logistics for HA meetings, management of HA fees, receipt of incoming HA correspondence
? Responsible for ordering & tracking of specific regulatory requirements eg. i) registration samples, ii) Certificates of Pharmaceutical Product & associated legalization where appropriate iii) any other legal documentation eg. Letters of Authorization, Powers of Attorney, Translations as required.

Your Background:
? Relevant experience from elsewhere in Pharmaceutical Industry
? Some regulatory/medical/technical experience
? Good commercial and product awareness
? Some knowledge of regulatory submission, compilation, publishing and approval processes, standards, systems and tools.

Company:
Our client is a global pharmaceutical company with a major presence in the UK. Their purpose is to deliver life-changing medicines and to do this they are completely science-led and like to share this with the scientific, healthcare and business communities within the UK.

Location:
This Regulatory Affairs Associate role will be based at our clients site in Macclesfield, Cheshire.

Apply:
Entitlement to work in the UK is essential. For more information, please contact Dennis on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote reference 51710.


You must have the right to work in the UK. Learn more

  • Agency: CK Group
  • Contact: Dennis Beltman
  • Phone: 01438 870027
  • Reference: 51710
  • Updated: 24th September 2021
  • Expires: 22nd October 2021

CK Group

Share this job: