Senior Registration Officer

1 week ago

Hatfield, United Kingdom Viatris Full time

7540 Viatris UK Healthcare

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 realize 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 Senior Registration Officer (ETW) role will make an impact:

- Coordinate Confirmation of Submission Strategy (CoSS)
- Prepare and submit national variations, renewals, responses to questions, or other submissions as required to the National competent UK authorities according to agreed company procedures and objectives (for new and established products)
- Provide UK national support for new product MR/DC or CP submissions managed by CRA teams
- Liaise with UK the Commercial team to support UK launches, re-launches, switches, and transfers (supply chain, demand/forecasting, marketing, pricing)
- Provide regulatory input for designated established products to ensure legal requirements are complied with
- Provision of relevant documentation to internal and external customers to allow the release of medical product to the market
- Ensure SPPs for UK National licences are maintained and manage Sunset Clause status for all UK Marketing Authorisations in line with local policy and EU regulations
- Ensure and maintain product information and artwork for designated UK marketed within the correct system, and reflects current registered versions
- Update the eMC database with any changes to approved SmPCs and PILs
- Create Abbreviated Prescribing Information as requested to support Marketing team activities
- Assist with the implementation of UK risk management plan activities
- Provide support to other UKRA team members as required and assist other UKRA team members produce documentation and submission dossiers of an acceptable

About Your Skills & Experience
- 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.

What we offer:

- 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 and 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

Sustainability 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.

Viatris is an Equal Opportunity Employer.

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