Principal Registration Officer
Apply locations: Hatfield, England, United Kingdom
Time type: Full time
Posted on: Posted 4 Days Ago
Job requisition id: R5649945
About Viatris
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:
1. Access – Providing high quality trusted medicines regardless of geography or circumstance;
2. Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
3. Partnership – Leveraging our collective expertise to connect people to products and services.
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:
* 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 .
Viatris is an Equal Opportunity Employer.
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