Senior Regulatory Assistant (12 month fixed term contract)

Provide administrative and regulatory support to the regulatory teams to enable dossiers to be submitted within agency or departmental specified timelines. 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 Senior Registration/Regulatory Officer role will make an impact:

• Assist the regulatory teams with the compilation and dispatch of regulatory dossiers to competent Authorities / local Affiliates (as required), including support for all associated administrative activities.
• Provide support to the regulatory teams to maintain databases and systems, as directed by Regulatory Officer(s).
• Provide support to the regulatory teams with the maintenance of SPPs, where required.
• Manage tasks relating to submission fees (telegraphic transfers, invoices, purchase orders) for the team or department.
• Assist with, or provide responses to internal or external queries, as appropriate with support from team members.
• Retain, store, and manage regulatory information in-line with departmental guidance to ensure effective and timely retrieval (electronic and paper).
• Help organise meetings for the team and department, as required.
• Assist the department with any ad-hoc administrative activities as required including organising travel arrangements and helping with organisation for external visitors.
• Maintain marketing authorisations for a small portfolio of low maintenance products (with support from Line Manager or designate). Ensure on-time submissions for all safety related changes for assigned projects.
• Ensure suitable dossiers (post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review (with support from Line Manager or designate) data intended for submission and identify any potential deficiencies or issues.
• Ensure databases and systems (including D2, 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.
  
  For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
• BSc in Life sciences or related area.
• Extensive and proven 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.
• Previous experience in mentoring junior team members.
• Proven ability to effectively participate in working groups or project teams, and successfully collaborate with colleagues.
• Computer literacy with Microsoft Office Suite and Documentum-based applications.
  
  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., 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 https://www.viatris.com/en/Careers/Diversity-and-Inclusion 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 we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

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
• 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 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.