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Reg. Affairs Associate 70k

Job description

My client a leading Cork Pharma company urgently require a Senior Regulatory Affairs Associate.

This contract role will report to the Associate Director of Regulatory Affairs.

Key duities of the role will include (but not limited to) :

  • Performs checks to support regulatory CMC queries from all site groups.
  • The ability to process GMP documentation supporting global submissions.
  • Responsible for the authoring of documentation to support regulatory submissions globally.
  • Assist in the preparation for interactions with global regulatory authorities.
  • Be seen as the "go to" person for CMC regulatory submissions @ site meetings
  • He/she will be comfortable supporting regulatory filings with Regulatory bodies.
  • Experienced in identifying issues & suggesting ways to mitigate risks.
  • Ensure consistent communication within the department and with other functional areas.
  • Interact with all Regulatory partners, internal cross functional teams, & consultants.

What you'll need .

  • 4 years exposure in a cGMP regulated setting, with proficiency in CMC Regulatory Affairs or related.
  • Candidate should demonstrate initiative & have expertise working independently & collaboratively.
  • A proven problem solver with strong understanding of submissions & management skills. 
  • Ability to comprehend technical information related to equipment & regulatory expectations.
  • Understanding & familiarity with FDA & European regulatory requirements, guidelines, & expectations.

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