Regulatory Compliance Specialist

1 month ago


Hatfield, Hertfordshire, United Kingdom Lifelancer Full time
Job Description:

Via global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas.

About the Role:
  • We are seeking a highly motivated Regulatory Labelling Intern to support creation, verification, maintenance and/or justification of Safety and Regulatory compliant Product Information (PI) texts (Labelling), and associated activities.
  • The successful candidate will preferably be currently enrolled in an accredited university in a pharmacy or life sciences degree course, or recently completed a similar degree course.
  • This role will have impact on PI texts and Labelling requirements.
Responsibilities:
  1. Reviewing of proposed, or approved, PI texts for compliance with relevant mandated safety triggers and CMC data.
  2. Updating the SmPC, confirming compliance with mandated safety triggers, CMC and relevant Labelling requirements.
  3. Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
  4. Working with team to learn Regulatory submission strategy relating to proposed changes to the PI texts.
Benefits:
  • We offer competitive salary £25,000 - £35,000 per year depending on qualifications and experience.
  • Hybrid work model available.
  • Focus on career progression with growth and development opportunities.
  • Emphasis on Health Wellness programmes.
  • 100% paid medical insurance and Employee Assistance Programme.


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