Associate Regulatory Affairs Manager (12 Month Fixed Term Contract)

Viatris; Hatfield; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking an Associate Regulatory Affairs Manager for a 12-month fixed-term contract in Hatfield, England. The successful candidate will ensure timely marketing authorizations, develop regulatory strategies, and mentor team members in a collaborative environment focused on health improvement. This role requires a BSc in a related field and a proven background in regulatory affairs, offering competitive salaries and a strong commitment to diversity and inclusion.

Benefits

Top Employer Accreditation

Discretionary annual bonus

Career growth opportunities

Health & Wellness programs

Paid medical insurance and Employee Assistance Program

Life insurance

Employer-matched pension (up to 11%)

Two paid volunteer days per year

Qualifications

• Proven experience in the pharmaceutical regulatory environment required.
• Candidates should demonstrate strong organizational and communication skills.
• Knowledge of TrackWise and Documentum is beneficial.

Responsibilities

• Obtain and maintain marketing authorizations for products in the UK.
• Prepare and dispatch marketing authorization applications and submissions.
• Liaise with internal teams to ensure regulatory alignment.

Skills

Organizational skills

Communication skills

Proficiency in MS Office

Regulatory experience

Education

BSc or equivalent in Pharmacy, Life Sciences

Tools

TrackWise

Documentum

Job description

Associate Regulatory Affairs Manager (12 Month Fixed Term Contract)

Location: Hatfield, England, United Kingdom

Posted on: 5 days ago

Job Requisition ID: R5659293

At Viatris, we envision health not as it is, but as it should be. We act with courage and our unique positioning provides stability in a world of evolving healthcare needs. Viatris enables everyone worldwide to live healthier at every stage of life through three main axes:

• Access: Providing high-quality, recognized medicines regardless of patient location or situation.
• Leadership: Promoting sustainable growth and innovative solutions to improve patient health.
• Partnership: Valuing collective expertise to ensure access to our products and services.

Our global portfolio includes iconic brand-name products, generics, and other offerings across therapeutic areas. We are committed to creating healthier communities through education, outreach, and better access to treatment.

For those driven to live with purpose, Viatris fosters a collaborative culture that encourages courage and resilience. We are more than just a workplace; we are a place to make a difference.

The Role & Responsibilities

Obtain and maintain marketing authorizations for products in the UK. Support departmental initiatives and assist the Line Manager.

Key duties include:

• Preparing and dispatching dossiers for marketing authorization applications and post-approval submissions.
• Reviewing submission data and advising on deficiencies.
• Developing regulatory strategies for new applications and submissions.
• Maintaining marketing authorizations and ensuring timely safety-related updates.
• Updating databases and systems per SOPs.
• Liaising with third parties and internal teams to ensure alignment on regulatory activities.
• Reporting project status and addressing potential delays.
• Staying informed on regulatory requirements and ensuring compliance.
• Mentoring team members and maintaining product information and artwork.
• Managing Sunset Clause statuses and representing the UK regulatory affiliate in meetings.
• Supporting projects as a departmental lead or team member.

Skills & Experience

Candidates should have:

• A BSc (or equivalent) in Pharmacy, Life Sciences, or related fields.
• Proven experience in the pharmaceutical regulatory environment.
• Strong organizational and communication skills.
• Proficiency in MS Office; knowledge of TrackWise and Documentum is a plus.
• Excellent written and oral communication skills.

We encourage applicants even if their experience does not match all requirements, as we value diverse backgrounds.

Benefits

We offer competitive salaries, benefits, and an inclusive environment, including:

• Top Employer Accreditation
• Discretionary annual bonus
• Career growth opportunities
• Health & Wellness programs
• Paid medical insurance and Employee Assistance Program
• Life insurance
• Employer-matched pension (up to 11%)
• Two paid volunteer days per year

Diversity & Inclusion

We are committed to diversity and inclusion. Learn more at Viatris Diversity & Inclusion.

Sustainability

We prioritize responsible, sustainable operations and community empowerment. More at Viatris Corporate Responsibility.