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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