Director of Regulatory Affairs

3 days ago


Hatfield, Hertfordshire, United Kingdom Viatris Company Full time

Job Description:

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This is an emerging senior level position recognized as an expert for global CMC regulatory knowledge and quality expertise.

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Responsibilities:

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  • Guide, develop, and execute regional and global regulatory CMC strategies specific to assigned Viatris's eyecare portfolio to meet the needs within the regions.
  • Facilitate timely regulatory submission and approval by managing adherence to the Regulatory Affairs schedule for new applications and deficiency responses.
  • Direct activities to ensure the required documentation is prepared to a high standard and that all regulatory requirements and/or commitments are met for obtaining Marketing Authorizations.
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Requirements:

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To be successful in this role, you will need:

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  • A minimum of a Bachelor's degree (or equivalent). A Master's degree (or equivalent) preferred.
  • Extensive pharmaceutical experience with relevant technical experience (Quality, Technical Services, R&D) and pharmaceutical regulatory experience required.
  • Prior experience managing projects and matrixed teams and/or serving as a people manager.
  • Global Regulatory Affairs CMC strategy, with hands-on CMC authoring experience (initial registrations or post-approval variations).
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Estimated Salary:

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The estimated salary for this role is €80,000 - €110,000 per annum, depending on experience.

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Benefits:

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Viatris offers excellent career progression opportunities, work-life balance initiatives, bonus scheme, health insurance, and pension.



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