CMC Global Regulatory Strategist

2 weeks ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €100,000

Job Description:

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  • The Regulatory Affairs Manager CMC (Global) is a key role in our organization that involves regulatory knowledge and experience, balanced judgment, crisp decision-making, exemplary collaboration, and business acumen.
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We are seeking a candidate with hands-on CMC authoring experience, 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).

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Key Responsibilities:

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  • 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.
  • 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.
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Benefits:

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  • 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.
  • Opportunities for career progression and work-life balance initiatives.
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Viatris offers a diverse and inclusive workplace, committed to building a truly authentic culture. If you're excited about this role but your past experience doesn't fully align with every requirement, we still encourage you to apply.

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Why Viatris?

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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.

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Sustainability at Viatris

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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.

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