Regulatory Affairs Executive (24 months External Temporary Worker contract)

Viatris; Hatfield; On-site; GBP 30,000 - 50,000; Full time

Job summary

An established industry player seeks a Regulatory Affairs Executive to manage and coordinate regulatory activities in a dynamic environment. In this role, you will ensure compliance with regulatory strategies while preparing post-approval submissions and liaising with stakeholders. This position offers an opportunity to contribute to impactful projects within a collaborative team. If you have a keen eye for detail and a passion for regulatory affairs, this role is perfect for you!

Qualifications

• Experience in a fast-paced regulatory environment.
• High-quality documentation and attention to detail.

Responsibilities

• Coordinate regulatory activities for post-approval submissions.
• Develop regulatory strategies and maintain compliance.

Skills

Regulatory Affairs Experience

Documentation Skills

Attention to Detail

Analytical Skills

Communication Skills

Tools

Change Management Systems

Regulatory Information Management Systems

Job description

Regulatory Affairs Executive (24 months External Temporary Worker contract)

Viatris Hatfield, England, United Kingdom

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Role Overview

The Regulatory Affairs Executive will manage and coordinate regulatory activities supporting special projects, ensuring compliance with regional and global regulatory strategies. Responsibilities include preparing and dispatching post-approval submissions, devising regulatory strategies, maintaining regulatory compliance, liaising with stakeholders, and supporting audits and other regulatory activities.

Key Responsibilities

1. Coordinate regulatory activities for post-approval submissions, including labelling changes.
2. Ensure timely preparation and dispatch of post-approval submissions; review data for deficiencies.
3. Develop regulatory strategies for post-approval activities.
4. Maintain awareness of regulatory requirements and liaise with authorities.
5. Collaborate with internal teams and third parties to ensure alignment and effective communication.
6. Represent UK regulatory interests in project meetings.
7. Update databases, systems, and product information accurately.
8. Support audits and provide regulatory support to team members.

Qualifications & Skills

• Experience working independently in a fast-paced regulatory environment.
• Technical UK Regulatory Affairs experience with high-quality documentation skills.
• Attention to detail in reviewing labelling, artwork, and advertising for compliance.
• Experience with regulatory systems like Change Management and Regulatory Information Management Systems.
• Strong analytical and strategic assessment skills.
• Excellent communication skills for conveying regulatory information effectively.

Additional Information

Viatris values diversity, inclusion, and sustainability. We encourage candidates from all backgrounds to apply, even if their experience does not align perfectly with every requirement. We offer competitive salaries, benefits, and a collaborative environment where you can make a difference.

Employment Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Business Development and Sales
• Industry: Pharmaceutical Manufacturing