Regulatory Affairs Executive 24 months agency contract

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 bestinclass iconic brandname 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

Management and coordination of regulatory activities to support special projects in accordance with departmental objectives and regional and global regulatory strategy. Any other activities relating to obtaining and maintaining marketing authorisations for products in the UK.

Every day we rise to the challenge to make a difference and heres how the Regulatory Affairs Executive role will make an impact :

Coordinate Regulatory activities for postapproval submissions particularly with respect to labelling changes and prepare supporting documentation.

Ensure suitable postapproval submissions are prepared and dispatched ontime according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues.

Devise regulatory strategies (including advising of the regulatory requirements) for postapproval submissions with support from Line Manager.

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.

Liaise closely with Artwork Supply Chain Quality Regulatory and other stakeholders to ensure alignment in all initiatives.

Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.

Represent the UK regulatory affiliate at project meetings as requested.

Ensure relevant information is communicated to appropriate stakeholders within the company.

Advise management of the status and progress of assigned projects identifying potential problems or delays and possible solutions as they occur and maintain a current status report for these projects.

Keep databases and systems updated inline with current SOPs so that uptodate information is available.

Use and update all appropriate company tracking tools in accordance with specified working processes.

Maintain product information and artwork within the correct system to reflect current registered versions.

Ensure the eMC database is updated with any changes to approved SmPCs and PILs.

Create and maintain Abbreviated Prescribing Information as requested to support Marketing team activities.

Assist with company audits (internal / external) as appropriate.

Provide support to other UKRA team members as required and perform any other regulatory activity as requested by line management.

About Your Skills & Experience

For this role were looking for a candidate who has an effective combination of the following qualifications skills and experiences :

Ability to work independently / with minimal supervision in a fastpaced and evolving regulatory environment effectively representing the regulatory function and inputting regulatory expertise when working as a member of a multidisciplinary team.

Applied technical UK Regulatory Affairs experience creating highquality documentation and submissions with limited oversight.

A keen attention to detail to identify any gaps and potential deficiencies in supporting data and proactively seek to minimize risk. Reviewing labelling artwork and advertising materials for regulatory compliance.

Experience of working with Quality and Regulatory systems is also preferred e.g. Change Management Systems Regulatory Information Management Systems Artwork Management Systems.

Ability to apply a strategic assessment and an analytical thought process to achieve a defensible conclusion.

Contribute to the development of regulatory recommendations and decisions. Recognise potential regulatory issues solutions and opportunities.

Excellent verbal and written communication skills allowing for the transfer of regulatory expertise to a variety professional audience and stakeholders.

At Viatris we are dedicated to building a truly diverse inclusive and authentic workplace so if youre excited about this role but your past experience doesnt 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

Focus on career progression with growth and development opportunities.

Hybrid work model

Emphasis on Health & Wellness programmes

100 paid medical insurance and Employee Assistance Programme

Life cover

Excellent employermatched 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 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 Viatris we offer competitive salar ies 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.

Key Skills

Athletics,Corporate Banking,IT Management,Facilities,IT Support

Employment Type : Full-Time

Experience : years

Vacancy : 1