Regulatory Affairs Associate

  • Salary: £130 Per day PAYE
  • REF Number: 00051710
  • Consultant: Dennis Beltman
  • Contact: 01438 870011
  • Date Published: 24.09.2021
  • Sector: Non-Specific
  • Location: Macclesfield, North West
  • Discipline: Regulatory Affairs

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
  • Providesupport 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 globalpharmaceutical 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 emailpharmacontracts@ckagroup.co.uk. Please quote reference 51710.

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