CMC Regulatory Support Specialist

5 days ago

Cork, Cork, Ireland beBeePharmaceutical Full time €60,808 - €91,360
Regulatory Affairs Specialist

We are seeking a highly skilled Regulatory Affairs Specialist to support the completion of CMC-related information for all submissions, including new product submissions and product renewal submissions.

This role requires strong knowledge of CMC regulatory requirements and the ability to coordinate global registration activities. The ideal candidate will have experience in pharmaceutical drug development or industry-related experience and possess excellent written, spoken, and presentation skills.

The Regulatory Affairs Specialist will work closely with stakeholders, including country Affiliate representatives, Regional Submission Associates, and manufacturing sites, to ensure timely and accurate submission support. This role also requires effective interpersonal skills, attention to detail, and the ability to prioritize tasks effectively.

The successful candidate will be responsible for:

  • Developing and utilizing appropriate information management expertise and country-specific knowledge to support the regulatory documentation required for all CMC elements of CTD module 1 and any regional information.
  • Coordinating global registration activities and requesting/providing the necessary documentation to affiliates for registration of products in global countries.
  • Demonstrating in-depth understanding of content requirements, including awareness and understanding of CTD format (module 1).
  • Preparing updates to CMC CTD content consistent with approved manufacturing changes and procedural requirements primarily for module 1 support.

This is an exciting opportunity for a motivated and organized individual who is passionate about regulatory affairs and has a strong interest in supporting the completion of CMC-related information.

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