Regulatory Affairs Specialist – Pharmaceuticals
Brenntag
full-time
Posted on:
Location Type: Hybrid
Location: Leeds • 🇬🇧 United Kingdom
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Support the regional Pharma division Sales Team on regulatory, legal, compliance, quality, and product safety topics related to raw material supply into the pharmaceutical industry.
- Complete technical and regulatory documentation and respond to customer information requests (e.g., questionnaires, supply chain agreements, QAA’s & TA’s).
- Source information internally and from suppliers to satisfy customer requests.
- Report and document customer requests via KPIs.
- Manage Process Change Control Notifications.
- Collaborate with commercial and value-added services teams on regulatory topics for customer projects.
- Work with QHSE & supply chain teams to ensure regulatory compliance and support implementation of new standards (IPEC GMP/GDP, EXCiPACT, GDP).
- Participate in EMEA Pharma Regulatory team projects.
- Create and manage product regulatory information in a standardised format.
- Provide training on regulatory topics to commercial and supply chain teams.
- Undertake any other tasks within capability to support the commercial success of the Pharma business unit.
Requirements
- Degree or significant experience in life sciences.
- Knowledge of pharmaceutical industry requirements and regulations on APIs, excipients, biopharma, and traditional pharma raw materials.
- Understanding of European National Competent Authority requirements for distribution of APIs, excipients, and raw materials.
- Fluent in English (spoken and written).
- Strong collaboration, communication, and interpersonal skills with the ability to work proactively across all levels and functions.
- Experience working with regulatory documentation (desirable).
- Knowledge of GxP requirements in Pharma and/or Biopharma (desirable).
Benefits
- Competitive salary and annual bonus scheme.
- 25 days holiday plus bank holidays.
- Pension plan and life assurance.
- Access to learning and development opportunities.
- Employee assistance programme and wellbeing initiatives.
- Career progression within a global organisation.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory documentationtechnical documentationProcess Change Control Notificationsregulatory complianceproduct regulatory informationGxP requirementsAPIsexcipientsbiopharmatraditional pharma raw materials
Soft skills
collaborationcommunicationinterpersonal skillsproactive worktraining