Regulatory Affairs Specialist - VAF315

We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to join our consulting company. The Regulatory Affairs Specialist will be responsible for ensuring compliance with regulatory requirements for the development, approval, and marketing of the client’s products in the UK.

Group 10 Responsibilities

Submission and Approval Process:

Preparation and submission of Technical/Site Transfer Applications

Preparation and submission of Marketing Authorisation Applications

Lifecycle Maintenance:

Preparation and submission of documentation for post-approval applications, including, but not limited to, Variations, Renewals, MAH Transfers/COAs, Labeling

Management of artwork generation, labeling, creation, and update of product information

Compliance:

Monitor and maintain up-to-date knowledge of regulations for the UK

Ensuring compliance with all regulatory processes, in readiness for both internal and external audits
Ensuring compliance with the regulations of the UK agency

Communication:

Act as a liaison between the PLG, PLG clients, and the regulatory agencies

Support internal requests for information

Group 12 Experience

5+ years of relevant experience in UK regulations

Experience in the management of artwork generation, labeling, creation, update of product information
Experience with: MLA, MAA, CTD, Variations, Renewals, Labeling, MAH Applications
Experience with software packages and databases (Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat etc.)
Good organizational skills and communication skills
Ability to prioritize and deliver high-quality work
Experience in people management/coordination is a plus
Experience in promotional/non-promotional activities is a plus