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.
£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.
? 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.
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.
This Regulatory Affairs Associate role will be based at our clients site in Macclesfield, Cheshire.
Entitlement to work in the UK is essential. For more information, please contact Dennis on 01438 870011 or email firstname.lastname@example.org. 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
Website: CK Group
- Updated: 24th September 2021
- Expires: 22nd October 2021