Manager, Pharmaceutical Compliance Specialist

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €95,000 - €110,000

Job Description:

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Viatris is a global healthcare services company that aims to provide accessible, high-quality medications to patients worldwide. We believe in health as it should be, enabling people around the world to live healthier at every stage of life.

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The Role:

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We are seeking a Manager, Regulatory Affairs Global CMC who will play a crucial role in ensuring global regulatory compliance by aligning with external requirements and internal quality procedures.

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Responsibilities:

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  • Ensure global regulatory compliance by aligning with external requirements and internal quality procedures">
  • Demonstrate regulatory expertise, sharp decision-making, and collaboration to develop and execute regulatory strategies, manage submissions, and review policies">
  • Create and execute robust regulatory strategies to mitigate risks and address technical and scientific challenges">
  • Prepare and deliver high-quality CMC submissions to global regulatory agencies, managing timelines and ensuring alignment with regulatory commitments">
  • Serve as a CMC representative, managing project activities, assessing risks, and developing global regulatory strategies">
  • Support post-approval changes, new registrations, renewals, and responses to agency queries while performing quality reviews of CMC submissions">
  • Build strong relationships with internal and external partners, including regulatory authorities, to drive regulatory success">
  • Mentor colleagues, provide technical guidance, and share expertise to advance team capabilities">
  • Participate in pharmaceutical industry conferences and represent the company on advisory committees when required">
  • Manage and contribute to CMC-related projects, initiatives, and training activities, while adhering to the company's values and principles of integrity">
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About Your Skills & Experience:

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We are looking for a candidate who has an effective combination of the following qualifications, skills, and experiences:

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  • Degree in Natural Sciences with 6 years pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and a minimum of 3 years pharmaceutical regulatory experience required">
  • At least 2+ years of hands-on CMC authoring experience, including initial registrations or post-approval variations">
  • Solid understanding of cGMPs, development, and commercial activities to assess the technical and regulatory merits of CMC data">
  • Knowledge of global regulatory requirements, submission processes, and interactions with regulatory authorities">
  • Proven ability to interpret and apply global and regional CMC guidelines to shape strategic regulatory directions">
  • Awareness of emerging scientific and manufacturing technologies and their application in regulatory strategies">
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Benefits:

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We offer 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.

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Diversity & Inclusion at Viatris:

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We value diversity and inclusion at Viatris and believe that our differences are essential to our mission. If you would like to learn more about what diversity, equity, and inclusion means to us, please visit

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Sustainability at Viatris:

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We are committed to sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit

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