Regulatory Affairs Manager

CK Group are recruiting for a Regulatory Affairs Manager to join a company in the pharmaceutical industry at their site based in Basingstoke on a contract basis for 12 months. This is a hybrid role and you will need to be in the office 3 days per week and 2 days from home.

Salary:

Up to £60.32 per hour PAYE

Company:

Our client is one of the largest pharmaceutical companies in the world. They focus on finding answers for some of the world's most urgent medical needs.

Location:

This Regulatory Affairs Manager role will be based at our clients site in Basingstoke, Hampshire.

Regulatory Affairs Manager Role:

• Lead the Regulatory Affairs Group to ensure the success of new product registration, line extensionsand new indications in alignment with the affiliate business plan, while maintaining compliance for all products with local regulations and quality system requirements.
• Develop and implement the regulatory plan and strategy in alignment with affiliate business plans as well as regulatory requirements.
• Ensure submission and approval of high-quality regulatory applications within planned timelines. Maintain clear metrics for regulatory deliverables.
• Represent the Regulatory Affairs function as appropriate in Affiliate Leadership Team, New Product Planning discussions and facilitate interactions with regulatory bodies on a regular basis.

Your Background:

• Educated to degree level or above in life science or a related field.• Significant experience in regulatory affairs at a Senior level, ideally in UK affiliate roles with extensive experience of submissions processes and interactions with regulatory authorities.
• Team leadership experience with proven experience in retention and development of people.
• Strong interpersonal, team working, negotiating, writing, presentation, and communication skills with influencing skills.

Apply:

For more information, or to apply for this Regulatory Affairs Manager position please contact the Key Accounts Team on 01438 870011 or email pharmacontracts@ckagroup.co.uk. Please quote job reference 56287.

Please note:

This role is subject to a satisfactory basic Disclosure and Barring Service (DBS) check. It is also essential that applicants hold entitlement to work in the UK