Viatris inc.
Location
Hatfield, Hertfordshire | United Kingdom
Job description
Registration Officer (12 months contract) page is loaded
En VIATRIS, vemos la atención médica no como es, sino como debe ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en evolución. Viatris permite a las personas de todo el mundo vivir de manera más saludable en cada etapa de la vida. Lo hacemos a través de:
Acceso : suministro de medicamentos confiables de alta calidad independientemente de la geografía o las circunstancias;
Liderazgo : promover operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;
Asociación : aprovechando nuestra experiencia colectiva para conectar a las personas con productos y servicios.
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 suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues.
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.
Prepare regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions with support from Line Manager.
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
For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
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.
Computer literacy with Microsoft Office Suite and Documentum-based applications.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
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 we serve. To learn more about our efforts, please visit
En Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.
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