Regulatory Compliance Specialist
1 month ago
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.
- Reviewing of proposed, or approved, PI texts for compliance with relevant mandated safety triggers and CMC data.
- Updating the SmPC, confirming compliance with mandated safety triggers, CMC and relevant Labelling requirements.
- Authoring of the Package Leaflet (PL) and Labelling, ensuring consistency with the proposed, or approved, SmPC, relevant safety triggers and Labelling requirements.
- Working with team to learn Regulatory submission strategy relating to proposed changes to the PI texts.
- 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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