Global Regulatory Affairs Manager

4 days ago

Dublin, Dublin City, Ireland beBeeCompliance Full time €90,000 - €120,000
Regulatory Affairs Manager CMC Job Description

This is a challenging role for an experienced regulatory affairs professional to work in our global organization. As a Regulatory Affairs Manager CMC, you will be responsible for developing and implementing regulatory strategies to ensure compliance with global regulations.

  • Develop and implement regulatory strategies to mitigate risks and ensure compliance with global regulations.

  • Prepare and deliver high-quality CMC regulatory submissions and 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.

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