Regulatory Affairs Specialist - VAF315

Groupe ProductLife; United Kingdom; Remote; GBP 40,000 - 60,000; Full time

Job summary

A consulting company is seeking a Regulatory Affairs Specialist to ensure compliance with UK regulatory requirements. The role involves preparation and submission of applications, lifecycle maintenance, and effective communication with regulatory agencies. The ideal candidate will have over 5 years of experience and a strong understanding of regulatory processes.

Qualifications

• 5+ years of relevant experience in UK regulations.
• Experience in the management of artwork generation and product labeling.
• Familiarity with MLA, MAA, CTD, Variations, and Renewals.

Responsibilities

• Ensure compliance with UK regulatory processes for product marketing.
• Prepare and submit Technical/Site Transfer and Marketing Authorisation Applications.
• Act as a liaison between PLG and regulatory agencies.

Skills

Organizational Skills

Communication Skills

Regulatory Knowledge

Tools

Microsoft Office Suite

Veeva Vault

Trackwise

PromoMat

Job description

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.

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 UKagency

Communication:

• Act as a liaison between the PLG, PLG clients, and the regulatory agencies
• Support internal requests for information

Experience

• 5+ years of relevant experience in UKregulations
• 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