Registration Officer
3 months ago
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.
Our 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. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.
For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.
The Role & What You Will Be Doing
Registration Officer role will be responsible to obtain and maintain marketing authorisations for products in designated EU and non-EU territories (internal and 3rd Party / BD). Perform any other regulatory activities as required by company strategy.
Every day, we rise to the challenge to make a difference and here’s how the Registration Officer role will make an impact:- Ensure on-time submissions for all safety related changes for assigned projects.- Ensure databases and systems (including D2, GLAMS, MyPortfolio and TrackWise) are updated in-line with current SOPs and up-to-date information is available for all assigned products.- Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance.- Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.- Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.-
- Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.- Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.- Embrace the One Team approach across all Regional Submission Teams by ensuring- consolidation of work-sharing activities in line with Senior Management guidance, for example increased sharing of expertise and knowledge, combined meetings and collaboration on initiatives and working groups.
About Your Skills & Experience- BSc or equivalent in Life Sciences or related area.- Demonstrable experience in Regulatory Affairs.- Effective verbal and written communication skills.- Proven experience in managing large volume and fast paced product portfolios.- Flexible approach to enable prioritisation in line with company requirements.- Proven ability to effectively participate in working groups or cross functional project teams, and successfully collaborate with colleagues.Benefits at Viatris
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. Some of our benefits include the following on top of a competitive salary:
- Top Employer Accreditation, demonstrating that we provide excellent people policies and practices- Competitive compensation package inclusive of annual discretionary bonus- Focus on career progression with growth and development opportunities- Emphasis on Health & Wellness programmes- 100% paid medical insurance and Employee Assistance Programme- Life cover- Excellent employer-matched pension scheme with Viatris contributing up to 11%- 2 paid volunteer days per year
Diversity & Inclusion at Viatris
At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit
Sustainability at Viatris
Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities
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