PE Global High Wycombe, England, United Kingdom
Regulatory Affairs Associate
PE Global High Wycombe, England, United Kingdom
Direct message the job poster from PE Global
PE Global is hiring a Regulatory Affairs Associate (FMCG/EMEA) for our personal care client based in High Wycombe office until Dec and Reading Office thereafter from January. The rate for this role is £67.00 Umbrella p/hour.
* Initial 6 month role but with the opportunity to apply for a perm role
* Hybrid working, onsite at least 2 days per week.
Responsibilities:
Regulatory Strategy & Execution
* Develop and implement global and/or regional regulatory strategies in collaboration with internal stakeholders.
* Prepare and submit regulatory dossiers and documentation aligned with applicable regulations.
* Support regulatory activities for EU procedures (e.g., MRP, DCP, national).
* Monitor the progress of applications and proactively manage regulatory timelines and risks.
* Stay abreast of evolving regional regulatory requirements and ensure knowledge is applied effectively.
Regulatory Compliance
* Ensure regulatory systems and documentation are current and compliant.
* Participate in SOP training, audits, and inspections alongside the Quality function.
* Document and track communications and outcomes with regulatory authorities.
* Identify, escalate, and support resolution of compliance issues, implementing corrective/preventive actions as needed.
Cross-Functional Collaboration
* Represent Regulatory Affairs in cross-functional teams, providing expert guidance.
* Support business continuity and crisis management initiatives through effective regulatory leadership.
* Maintain strong relationships with internal and external stakeholders using clear and persuasive communication.
Essential Qualifications & Experience
* Bachelor's Degree (or higher) in Life Sciences, Chemistry, or Pharmacy.
* Proven experience in Regulatory Affairs across medicines and food supplements within the EMEA region.
* Deep understanding of EMEA regulatory frameworks and product lifecycle management.
* Proficiency in English (verbal and written).
PE Global cannot provide sponsorship. Candidates will need the full right to live and work full time within the UK for at least the next 12 months.
Seniority level
* Seniority level
Not Applicable
Employment type
* Employment type
Contract
Job function
* Job function
Product Management and Science
* Industries
Pharmaceutical Manufacturing and Public Health
Referrals increase your chances of interviewing at PE Global by 2x
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