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Regulatory Affairs Specialist, high wycombe
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Client:
PE Global
Location:
high wycombe, United Kingdom
Job Category:
Other
-
EU work permit required:
Yes
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Job Views:
3
Posted:
05.05.2025
Expiry Date:
19.06.2025
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Job Description:
PE Global are currently recruiting for a Regulatory Affairs Specialist -CMC- for a contract role with a leading multinational Consumer Health client based in High Wycombe (hybrid).
Responsible for the development of CMC/technical regulatory strategies across the EMEA region providing regulatory input and technical guidance on regional regulatory requirements to product development teams within the Self Care franchise.
Responsibilities
• Provides strategic regulatory input and technical guidance on regional regulatory requirements to product development teams.
• Supports the business initiatives, by strengthening propositions, influence and acts as strategic advisor on brand/need state portfolio forums.
• Participates in cross-functional project teams to define development program requirements and risks.
• Prepares and submits regulatory submissions according to applicable regulatory requirements and guidelines in EMEA.
• Maintains awareness of current regulations and anticipate implications and opportunities because of changes to the relevant regulatory environments.
• Communicates changes to appropriate management and cross functional experts as appropriate.
• Ensure that all products comply with local regulatory and quality system requirements.
• Ensures quality and compliance in all actions.
• Participate in the development and implementation of, and maintains compliance with, all applicable Processes, SOPs and working instructions.
• Ensures that the enterprise Regulatory systems are accurate and fully maintained.
• Ensures any compliance issues are reviewed and escalated and relevant corrective/preventative actions are implemented locally.
• Identifies and/or implements regional process improvement opportunities and ensures implementation of relevant global or regional regulatory initiatives.
• Evaluates deliverables of self/direct reports against set timelines, acting where necessary to minimize delays and anticipate difficulties/risks.
Requirements
• Relevant Bachelor's Degree or higher
• Expertise across a broad spectrum of Regulatory classifications including Drugs, Dietary Supplement and/or Medical Devices, mainly pharmaceutical CMC regulatory affairs
• Knowledge of regulatory frameworks and external environments in the EU and wider EMEA and the ability to apply these to regulatory solutions throughout the product lifecycle.
• Solid understanding of regulatory CMC in the markets of relevance
Interested candidates should submit an updated CV.
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***
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