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Regulatory Affairs Specialist - 090, Cambridge
Client: ProductLife Group
Location: Cambridge, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 26a42f4ecb67
Job Views: 15
Posted: 28.04.2025
Expiry Date: 12.06.2025
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, new registration, and post-approval applications.
* Assist with the preparation of Marketing Authorization Applications (MAAs).
* Prepare and submit documentation for post-approval applications (e.g., Type IA, Type IB, Type II, Renewals, MAH Transfers/COAs).
* Prepare and submit Technical/Site Transfer Applications.
* Assist with license applications as required.
* Manage artwork generation, labeling, and product information updates, including review of packaging texts and regulatory compliance checks.
* 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 tools for document creation, data management, and information retrieval.
* Perform regulatory administration duties and ensure compliance.
* Track regulatory submissions and approvals.
* Contribute to data entry for KPI and metrics measurement.
Qualifications
* Bachelor’s Degree in Life Sciences or Pharmacy.
* At least 5 years of experience in Regulatory Affairs within a pharmaceutical company or service provider.
* Experience with UK Life Cycle Maintenance (LCM) and ideally EU LCM.
Skills
Technical 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.
* Experience in people management is a plus.
* Experience with new drug registration and promotional activities is advantageous.
* Fluency in English.
Soft Skills
* Excellent communication, organizational, and interpersonal skills.
* Strong coordination and multitasking abilities.
* Ability to work independently and in teams, with attention to detail and solution-oriented mindset.
About us
ProductLife Group offers regulatory outsourcing and consulting services globally. Founded in 1994, headquartered in Paris, with offices worldwide, supporting clients across the life sciences industry. We value enthusiasm, challenge acceptance, and professional growth. Join us to develop your career in a supportive environment.
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