Regulatory Affairs Manager CMC (Global) – Based Anywhere in Europe

Viatris Hatfield, England, United Kingdom

Join or sign in to find your next job

Join to apply for the Regulatory Affairs Manager CMC (Global) – Based Anywhere in Europe role at Viatris

Regulatory Affairs Manager CMC (Global) – Based Anywhere in Europe

Viatris Hatfield, England, United Kingdom

Join to apply for the Regulatory Affairs Manager CMC (Global) – Based Anywhere in Europe role at Viatris

McDermott Laboratories Limited

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 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

Every day, we rise to the challenge to make a difference and here’s how the Regulatory Affairs Manager CMC (Global) – Based Anywhere in Europe role will make an impact:

• Demonstrate regulatory knowledge and experience, balanced judgment, crisp decision-making, exemplary collaboration and business acumen, i.e., regulatory strategy development, regulatory submission quality, investigations, review of policy and quality standards
• Develop robust regulatory strategies, leveraging both technical and regulatory knowledge, to mitigate risks.
• Prepare and deliver high-quality CMC regulatory submissions & submission management plans for global regulatory agencies.
• Execute using regulatory policies and operational processes for delivering the product portfolio.
• Serve as CMC representative on a core project(s), manage project activities, assess regulatory risks and develop plans to develop global regulatory strategies for programs in accordance with regulatory, scientific and technical criteria.
• Manage regulatory issues, maintain submission information in relevant CMC systems, track regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
• Present and articulate issues for resolution, communicating regularly with key stakeholders to ensure alignment and providing consultation as a scientific/technical resource for assigned projects, mentoring and sharing experience with colleagues.
• Author and/or coordinate CMC activities for new registrations, post approval changes, renewals, annual reports and line extensions to meet filing requirements. Coordinate and contribute to responses to Agency queries and perform quality review of regulatory CMC submissions.
• Serve as a technical and scientific resource and provide guidance for completion of difficult and complex projects.
• Develop effective relationships with local and global internal partners, i.e., R&D; Quality; Global, Country & Regional Regulatory Leads; other CMC lines.
• Execute training related activities (e.g. compliance-related, HR policies) and individual development plans, participate in cross-disciplinary forums and learning opportunities, engage in Straight Talk and Listen exchanges, demonstrate and model adherence to all Viatris’ behaviors and values, embrace and comply with Principles of Integrity.
• Manage and contribute to CMC-related projects, initiatives and actions.
• Participate, as required, in pharmaceutical industry conferences or serve externally as a representative to pharmaceutical trade group advisory committees relevant to CMC functions.
  
  
  

• Mandatory hands-on CMC authoring experience (initial registrations or post-approval variations)
• Sufficient level of knowledge and solid understanding of the development and commercial activities and cGMP’s required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).
• Technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden and improve regulatory flexibility commensurate with business needs.
• Regulatory requirements and expectations, criteria for submission and approval globally and experience of interactions with regulatory authorities for projects.
• Updating, interpreting, and applying global and regional CMC guidelines, along with the ability to contribute to global regulatory strategies by proactively discussing with partners.
• Emerging awareness of new scientific or manufacturing technology.
• Sound understanding of business expectations across divisions
• Sound understanding and advanced knowledge of the principles, practices and concepts of regulatory CMC/ policy/ publishing disciplines and a working knowledge of the principles, practices, concepts and operations in other relevant disciplines.
  
  
  

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Pharmaceutical Manufacturing

Referrals increase your chances of interviewing at Viatris by 2x

Get notified about new Regulatory Affairs Manager jobs in Hatfield, England, United Kingdom.

Slough, England, United Kingdom 2 weeks ago

Global Regulatory Affairs Manager (Global Program Regulatory Manager)

London, England, United Kingdom 2 weeks ago

Senior Specialist, European Country Regulatory Affairs

London, England, United Kingdom 5 days ago

Regulatory Affairs and Quality Assurance (RAQA) Manager

London, England, United Kingdom 2 months ago

Global Regulatory Affairs Associate Director (Senior Global Program Regulatory Manager)

London, England, United Kingdom 2 weeks ago

Risk and Regulatory Manager, Private Markets

London, England, United Kingdom 3 days ago

Quality Assurance Regulatory Affairs Manager

Senior Manager, Regulatory Science Late-Stage Programs

London, England, United Kingdom 2 months ago

High Wycombe, England, United Kingdom £70,000.00-£80,000.00 4 hours ago

Regulatory Compliance Manager, Amazon Payments UK (Compliance)

London, England, United Kingdom 2 weeks ago

London, England, United Kingdom 1 month ago

London, England, United Kingdom 1 day ago

Regulatory Compliance Manager, Amazon Payments UK (Compliance)

London, England, United Kingdom 5 days ago

Hatfield, England, United Kingdom 4 hours ago

Quality Assurance and Regulatory Affairs Manager

Assistant Manager - Regulatory Compliance

Client Lifecycle & Regulatory Operations Manager

London, England, United Kingdom 5 days ago

London, England, United Kingdom 2 weeks ago

Watford, England, United Kingdom 1 day ago

Chiswick, England, United Kingdom 1 day ago

Associate Director UK&IE Regulatory Affairs

Harlow, England, United Kingdom 1 week ago

Senior Scientific & Regulatory Affairs Manager – UK/IE Markets

Slough, England, United Kingdom 6 days ago

London, England, United Kingdom 7 hours ago

Associate Director of Global Regulatory Affairs

London, England, United Kingdom 6 days ago

Regulatory Affairs Manager – Oncology Cell Therapy

Uxbridge, England, United Kingdom 1 month ago

London, England, United Kingdom 3 weeks ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.