Regulatory Affairs Specialist - 300

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 our second biggest client in the world.

• Provide guidance and support to continue managing submissions and any other requests from different clients regarding the UK.
• Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products) and post-approval applications.
• Assisting with the preparation of Marketing Authorization Applications (MAAs).
• Preparation and submission of documentation for post-approval applications including, but not limited to, Type IA, Type IB, Type II variations, BSVs, Renewals, PIQ, BROMI and MAH Transfers/COAs
• Preparation and submission of Technical/Site Transfer Applications
• Assisting with license applications as required
• Management of artwork generation/ labelling/creation/update of product information: provide review of packaging texts, provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
• Responding to internal requests for technical and/or regulatory information.
• Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
• Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
• Use a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva Vault (or comparable EDMS), LorenZ, Trackwise, PromoMat, etc
• General regulatory administration duties and compliance requirements
• Document and track regulatory submissions and regulatory authority approval.
• Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

• At least a Bachelor’s Degree in Life Sciences, ideally a Pharmacy Degree (PharmD)

• At least 3 years of experience in RA in a Pharmaceutical Company or Service Provider
• UK and Ireland LifeCycle Maintenance (LCM) experience, ideally EU LCM experience as well

Hard/Technical skills:

• Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations) in the UK and ideally in the EU.
• Knowledge of UK regulation for pharmaceuticals (NCE, Biologicals and Biotech) and ideally Medical Devices, Combination products and Cosmetics
• Strong computer skills, including MS Office applications, data and document management systems
• Previous experience in people management/coordination would be an advantage
• Experience in the new registrations of drug products is preferable.
• Experience of promotional/non-promotional activities would be an advantage
• Fluency in English is required

Soft skills:

• Excellent communication skills
• Excellent organizational and interpersonal skills
• Very good coordination skills
• A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
• Ability to work well within a team and autonomously
• Ability to prioritize different workloads/multi-task
• Process orientated with good attention to detail
• Solution-driven