Principal Registration Officer
Location: Hatfield, England, United Kingdom
Time Type: Full Time
Posted on: Offer published yesterday
Job Requisition ID: R5649945
About Viatris
At Viatris, we envision health not as it is, but as it should be. We act with courage, and our unique positioning is a source of stability in a world where health needs are constantly evolving. Viatris enables everyone worldwide to live healthier at every stage of life through three major axes:
1. Access : By providing high-quality and recognized medicines, regardless of the residence or situation of each patient.
2. Leadership : By promoting the sustainable evolution of our activities and developing innovative solutions to improve patient health.
3. Partnership : By valuing our collective expertise to give everyone access to our 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.
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 authorizations for designated EU and non-EU territories (through internal and Third Party workstreams) to ensure on-time launches, continued supply, and compliance of all products.
* Ensure databases and systems are maintained in accordance with current SOPs to fulfill regulatory obligations.
* Advise Senior management of the status and progress of assigned projects to meet departmental and regional objectives and timelines; identify potential problems or delays, and propose possible solutions as they occur.
* Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practices, and through liaison with competent authorities).
* Provide expertise and specialist knowledge to support the department; mentor and train the 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 authorization 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 prioritization 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
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.
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.
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