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Registration Officer
3 months ago
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.
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.
The Role & What You Will Be Doing
Registration Officer role will be responsible in the management of regulatory activities in order to obtain and maintain marketing authorisations for products in the UK.
Any other registration or special project activities as required by line management in accordance with departmental objectives and regional and global regulatory strategy.
Every day, we rise to the challenge to make a difference and here's how the Registration Officer role will make an impact:- Maintain marketing authorisations for an assigned product portfolio. Ensure on-time submissions for all safety related changes for assigned projects.
- Devise regulatory strategies (including advising of the regulatory requirements) for post-approval submissions with support from Line Manager.
- Ensure suitable post-approval submissions are prepared and dispatched on-time according to agreed company procedures and objectives.
- Maintain product information and artwork for designated UK marketed products within the correct system, to reflect current registered versions.
- Ensure the eMC database is updated with any changes to approved SmPCs and PILs.
- Create and maintain Abbreviated Prescribing Information, as requested, to support Marketing team activities.
- Keep databases and systems updated in-line with current SOPs so that 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.
- Manage the Sunset Clause status for assigned UK Marketing Authorisations in line with local policy and UK requirements.
- Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.
- 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.
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.
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.
- Top Employer Accreditation, demonstrating that we provide excellent people policies and practices
- Competitive compensation package inclusive of annual discretionary bonus and stock options
- Focus on career progression with growth and development opportunities
- Hybrid work model
- 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
At Viat
