Regulatory Affairs Executive (24 months External Temporary Worker contract)

Viatris; Hatfield; On-site; GBP 30,000 - 60,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Executive for a 24-month agency contract. This role involves managing regulatory activities to support product authorizations in the UK, ensuring compliance with regulations, and preparing high-quality documentation for submissions. The ideal candidate will thrive in a fast-paced environment, demonstrating strong analytical skills and attention to detail. This position offers a competitive compensation package and opportunities for career progression within a diverse and inclusive workplace. Join a team committed to making a positive impact on health worldwide.

Benefits

100% paid medical insurance

Employee Assistance Programme

Life cover

Excellent employer-matched pension scheme

2 paid volunteer days per year

Focus on career progression

Health & Wellness programmes

Hybrid work model

Qualifications

• Experience in UK Regulatory Affairs with a focus on documentation.
• Ability to work independently in a fast-paced regulatory environment.

Responsibilities

• Coordinate regulatory activities for post-approval submissions.
• Maintain awareness of regulatory requirements and ensure compliance.

Skills

Regulatory Affairs

Documentation and Submissions

Attention to Detail

Analytical Thinking

Communication Skills

Education

Degree in Life Sciences or related field

Tools

Regulatory Information Management Systems

Change Management Systems

Artwork Management Systems

Job description

Regulatory Affairs Executive (24 months agency contract)

Regulatory Affairs Executive (24 months agency contract)

Location: Hatfield, England, United Kingdom

Time Type: Full-time

Posted on: Yesterday

Job Requisition ID: R5658114

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 main pillars:

1. Access: Providing high-quality, recognized medicines regardless of the patient's location or situation.
2. Leadership: Promoting the sustainable evolution of our business and the development of innovative solutions to improve patient health.
3. Partnership: Leveraging 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

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 here’s how the Regulatory Affairs Executive role will make an impact:

• Coordinate Regulatory activities for post-approval submissions, particularly with respect to labelling changes, and prepare supporting documentation.
• Ensure suitable post-approval submissions are prepared and dispatched on-time 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 post-approval 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 in-line with current SOPs so that up-to-date 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, we’re 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 fast-paced and evolving regulatory environment, effectively representing the regulatory function and inputting regulatory expertise when working as a member of a multi-disciplinary team.
• Applied technical UK Regulatory Affairs experience, creating high-quality 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.

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:

• 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 employer-matched 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.

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.