CMC Regulatory Strategist

1 week ago

Dublin, Dublin City, Ireland beBeeRegulatory Full time €135,000 - €165,000
Job Description

As a Regulatory Affairs Manager CMC (Global), you will be responsible for developing and executing regulatory strategies to ensure compliance with global regulations. You will work closely with cross-functional teams to assess technical, scientific, and regulatory merits of CMC information and develop plans to mitigate risks.

The role involves preparing and delivering high-quality CMC regulatory submissions and submission management plans for global regulatory agencies. You will also serve as a CMC representative on core projects, manage project activities, and assess regulatory risks. Additionally, you will present and articulate issues for resolution, communicate regularly with key stakeholders, and provide consultation as a scientific/technical resource.

You will have the opportunity to author and/or coordinate CMC activities for new registrations, post-approval changes, renewals, annual reports, and line extensions. You will also coordinate and contribute to responses to agency queries and perform quality review of regulatory CMC submissions.

Required Skills and Qualifications
  • Mandatory hands-on CMC authoring experience
  • Sufficient level of knowledge and solid understanding of development and commercial activities and cGMP's required to assess technical, scientific, and regulatory merits
  • Technical, functional, and industry knowledge to shape strategic direction of assigned projects
  • Regulatory requirements and expectations globally, along with experience of interactions with regulatory authorities
Benefits

We offer competitive salaries and benefits in an inclusive environment where you can use your experiences, perspectives, and skills to help make an impact on the lives of others. We are dedicated to building a truly diverse, inclusive, and authentic workplace.

About Us

We are a global healthcare company committed to delivering increased access to affordable, quality medicines for patients worldwide. We leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

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