Regulatory Compliance Expert

3 days ago

High Wycombe, Buckinghamshire, United Kingdom Lifelancer Full time

About the Role

We are seeking an experienced Regulatory Compliance Expert to lead our Pharmacovigilance team as a Lead Specialist. This is an exciting opportunity to join our dynamic team and contribute to ensuring compliance with Good Pharmacovigilance Practice (GVP) regulations.

Key Responsibilities

  • Plan, conduct, and report routine and non-routine audits of activities, data, internal facilities, and processes to verify adherence to corporate policies, internal standards, and regulatory requirements.
  • Lead Due Diligence, for-cause audits, cross-functional, system/service provider audits as defined by the scope.
  • Support other auditors in planning, conducting, and reporting audits.
  • Ensure relevant standard procedures, diagnostic tools, and audit plans are fully understood and applied in audit activities.
  • Participate in regulatory inspections in core and supporting roles.
  • Contribute to the overall PV Quality & Compliance strategy.
  • Assist in preparing and delivering training materials.
  • Advise and contribute to coaching, including audit outcomes and Corrective and Preventive actions.
  • Complete training requirements in a timely manner to ensure inspection readiness at all times.
  • Take an active role in projects assigned by the supervisor and interact with key stakeholders as appropriate.
  • Meet priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.
  • Provide expertise and knowledge to others in BRQC, Business Partners, and the core business sector on quality and compliance processes/procedures.
  • Interpret and apply regulations/policies to issues of moderate complexity when required.

What We Are Looking For

  • A minimum of a Bachelor's Degree is required.
  • A minimum of 5 years of experience in pharmacovigilance, quality, and/or compliance is required.
  • Comprehensive knowledge of the drug development process, applicable regulations (GxP), R&D practices, and scientific and quality terminology is required.
  • Expertise in GVP regulations and one or more specific compliance disciplines (GLP, GCP) preferred.
  • Knowledge of procedural and records management requirements in a regulated industry preferred.
  • Prior pharmaceutical, consumer personal products, and quality/compliance-related experience preferred.
  • Must have excellent communication skills and be fluent in written and spoken English.
  • Must be a team player, organized, and detail-oriented, and possess sound problem-solving and good negotiating skills.
  • Must be proficient in Microsoft Office applications and possess a Quality mindset.

Estimated Salary Range: £60,000 - £80,000 per annum, depending on experience.

About Lifelancer

Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. We connect talented individuals with opportunities in pharma, biotech, health sciences, healthtech, and IT domains.

Benefits

  • Competitive Benefit Package
  • Paid Company Holidays, Paid Vacation, Volunteer Time & More
  • Learning & Development Opportunities
  • Employee Resource Groups

Disclaimer

Lifelancer is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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