Regulatory Associate CMC – Pharma

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Regulatory Associate CMC – Pharma

  • Permanent
  • Cork
  • Posted 4 weeks ago

Purcelloleary Recruitment

Pharmaceutical

Regulatory Associate CMC

Purcelloleary Recruitment are looking to recruit a Regulatory Associate CMC for a pharmaceutical company in Co. Cork. This is a REMOTE position for the foreseeable future; however, the successful candidate must be able to be onsite in Cork.

Job responsibilities:

  • Lead CMC submission management process by providing knowledge of CMC regulatory requirements, including a comprehensive knowledge of ICH CTD and evolving global agency standards, of CMC RA submission processes, electronic submission regulations and guidance regarding structure requirements to CMC development teams regarding global CTAs and registration dossiers. Responsible for preparing CMC CTD content consistent with approved manufacturing changes, technical reports and procedural requirements.
  • Partner with the CMC RA Scientist to drive the execution of submission planning for global registration and maintenance submissions.
  • Implement and in some cases interpret global regulations and guidance’s and look to regulatory precedence into submission processes and publishing standards to ensure final document content and structure are aligned with local regulatory requirements. Partner with Lilly affiliate regulatory staff, as necessary, to gain alignment on establishing new submission standards to meet local agency requirements.

 

Job requirements:

  • Bachelor’s Degree in a scientific or health sciences discipline (e.g. pharmacy, chemistry or related scientific discipline)
  • Knowledge of pharmaceutical drug development or industry-related experience preferred.

 

 

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