Regulatory Affairs Specialist - 090

ProductLife Group; Cambridge; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in regulatory consulting seeks a Regulatory Affairs Specialist to enhance their UK presence. This role involves managing regulatory submissions, ensuring compliance with guidelines, and collaborating with a dedicated team. Ideal candidates will hold a relevant degree and possess extensive experience in regulatory affairs within the pharmaceutical sector.

Qualifications

• Minimum 5 years RA experience in a pharmaceutical company.
• UK LifeCycle Maintenance (LCM) experience preferred.

Responsibilities

• Provide guidance for client submissions and regulatory requests.
• Contribute to pre-licensing, registration, and post-approval activities.
• Prepare Marketing Authorization Applications (MAAs) and compliance updates.

Skills

Lifecycle maintenance activities

Drug product regulations

Leadership or coordination

Fluency in English

Education

Bachelor’s Degree in Life Sciences or Pharmacy

Tools

Microsoft Office

Veeva Vault

LorenZ

Trackwise

PromoMat

Job description

About the job

In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in the United Kingdom.

You will integrate a team of dedicated Regulatory Affairs professionals and will have the mission to develop PLG’s local UK Regulatory Affairs presence, taking responsibility for new regulatory activities related to the UK for several clients.

Responsibilities

• Provide guidance and support to manage submissions and requests from clients regarding the UK.
• Contribute to regulatory activities including pre-licensing, registration, and post-approval applications.
• Assist with preparation of Marketing Authorization Applications (MAAs).
• Prepare and submit documentation for post-approval applications such as Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs.
• Manage artwork generation, labelling, and product information updates, including review of packaging texts and labelling compliance.
• Respond to internal requests for technical/regulatory information.
• Ensure compliance with regulatory processes for audits.
• Stay updated on national and European guidelines/legislation.
• Use various software packages for document production, data management, and information retrieval (e.g., Microsoft Office, Veeva Vault, LorenZ, Trackwise, PromoMat).
• Perform regulatory administration duties and track submissions and approvals.
• Contribute to data entry for KPI and metrics measurement.

Qualifications

• Bachelor’s Degree in Life Sciences or Pharmacy.
• Minimum 5 years of RA experience in a pharmaceutical company or service provider.
• UK LifeCycle Maintenance (LCM) experience; EU LCM experience is a plus.

Skills

• Experience with lifecycle maintenance activities for drug products in the UK and EU.
• Knowledge of UK pharmaceutical regulations, medical devices, biotech, and cosmetics.
• Strong computer skills, including MS Office and data management systems.
• Leadership or coordination experience is advantageous.
• Experience with new drug registrations and promotional activities is preferable.
• Fluency in English.

Soft Skills

• Excellent communication, organizational, and interpersonal skills.
• Strong coordination abilities.
• Ability to meet tight deadlines without compromising quality.
• Team player with autonomy.
• Multitasking and prioritization skills.
• Detail-oriented and solution-driven.

About us

ProductLife Group provides world-class regulatory outsourcing and consulting services for the global life sciences industry. Headquartered in Paris, with offices worldwide, founded in 1994, and committed to employee growth and client success.