Regulatory Intern
4 days ago
1478 Generics [U.K.] Ltd.
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access - Providing high quality trusted medicines regardless of geography or circumstance;
Leadership - Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership - Leveraging our collective expertise to connect people to products and services.
Every day, we rise to the challenge to make a difference and here’s how the Regulatory Intern (Initiatives & Compliance - Europe) role will make an impact:
Key responsibilities for this role include:
- Support performance-related activities such as Key Performance Indicators (KPIs) and collation of metrics for key activities. Support data collation for monthly/ quarterly reporting, as required.- Support team members with activities required in association with Globally
- and/or Regionally
- driven initiatives, as required.- Develop a working knowledge of Viatris Regulatory Systems & Databases (for example Document Management System, MyPortfolio, TrackWise CMS); and Regulatory Processes & Procedures which may be relevant to the role.- Develop an awareness of Regulatory requirements (including legislation, guidelines, industry best practice). Liaise with Competent Authorities where required.- Collaborate with Regional Regulatory Management team, Regional Submissions team and EU Regulatory Affiliate Heads to support activities.- Where required, support Pharmacovigilance-related Submission activities at a Regional and Local level, including but not limited to: Periodic Safety Update Reports (PSURs), Signal Detection and Referrals.- Assist Line Manager by supporting departmental initiatives as may be required.- Advise management of the status and progress of activities to meet objectives and timelines; and maintain a current status report for these activities.
The minimum qualifications for this role are:
- Proficiency in speaking, comprehending, reading and writing English- An interest in project management would be useful.
At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.
Viatris is an Equal Opportunity Employer.
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