CMC Regulatory Strategist

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €123,000 - €123,456
Job Overview

The position of Regulatory Affairs Manager will play a pivotal role in shaping our regulatory strategies and ensuring compliance with global regulations.

Main Responsibilities:
  • Demonstrate knowledge and experience to develop robust regulatory strategies, mitigate risks, and prepare high-quality submissions.
  • Execute using regulatory policies and operational processes for delivering the product portfolio, manage regulatory issues, and maintain submission information in relevant systems.
  • Serve as representative on core projects, assess regulatory risks, and develop plans to develop global strategies for programs in accordance with regulatory, scientific, and technical criteria.
About You

We are seeking a candidate with an effective combination of qualifications, skills, and experiences:

  • Mandatory CMC authoring experience (initial registrations or post-approval variations).
  • A sufficient level of knowledge and solid understanding of development and commercial activities and cGMP's required to assess technical, scientific, and regulatory merits of CMC information, commitments, and data.
  • Technical, functional, and industry knowledge to shape strategic direction of assigned project(s), reduce regulatory burden, and improve flexibility commensurate with business needs.
Why Work with Us?

We offer competitive compensation and benefits, along with an inclusive environment where you can use your experiences, perspectives, and skills to make an impact on people's lives. We are dedicated to building a diverse, inclusive, and authentic workplace.

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