Principal Registration Officer
Solicitar locations Hatfield, England, United Kingdom
time type Tiempo completo
posted on Publicado ayer
job requisition id R5649945
About Viatris
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
Every day, we rise to the challenge to make a difference and here’s how the Principal Regulatory Officer role will make an impact:
Key responsibilities for this role include:
* Obtain and maintain generic and branded marketing authorisations for designated EU and non-EU territories (through internal and Third Party workstreams) to ensure on-time launches, continued supply and the compliance of all products.
* Ensure databases and systems are maintained in accordance with current SOPs to fulfil regulatory obligations.
* Advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines; identifying potential problems or delays, and possible solutions, as they occur.
* Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
* Provide expertise and specialist knowledge to support the department. Provide mentoring and training to department in specialist areas, as required.
* Attend and contribute at Principal Registration Officer meetings; proactively raise issues and collaborate effectively to propose solutions. Ensure company/regulatory decisions are disseminated to junior team members.
* Support Regulatory Manager through participation in or leadership of project teams and in the development of strategies for regional initiatives. Work alongside the Regulatory Management group to roll-out these initiatives.
* Provide mentoring, training and day-to-day support for junior team members as directed by the Regulatory Manager.
* Support junior team members by reviewing data intended for submission and provide advice on deficiencies and issues, and in the preparation of regulatory strategies for new marketing authorisation applications / post-approval submissions.
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 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 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:
* Excellent career progression opportunities
* Work-life balance initiatives
* Bonus scheme
* Health insurance
* Pension
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 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 Corporate Responsibility .
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