Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for an experienced Regulatory Affairs Manager to join their team
In this role, a typical day might include the following:
- Develops and maintains a solid understanding of regulatory requirements and the available regulatory guidance documents and resources.
- Assists with the planning, scientific writing and critical reviews of pre-INDs, INDs, IMPDs, BLAs, MAAs, annual reports, amendments, and supplements (eCTD) to ensure conformance with regulatory requirements and to provide a high-quality regulatory submission.
- Managing through ambiguity and make decisions based on regulatory requirements while working independently and with various cross-functional teams.
- Acts as product liaison and corresponds with FDA for CMC related submissions and information requests.
- Assesses CMC changes against regulatory filings to ensure compliance.
- Assesses manufacturing processes/specifications against regulatory filings for clinical product release requests.
- Maintains awareness of project timelines in order to ensure on-time submissions.
- Participates as needed in agency meetings to optimally communicate positions and understand agency feedback to support submissions.
This role might be for you if:
- 5 year’s experience in the pharmaceutical industry (BS/BA) or two years in industry with advanced degree.
- Possess a Strong biopharmaceutical or regulatory background.
- Attention to detail.
- Ability to interpret, communicate, strategize.
- A strong work ethic is a must.
- Ability to collaborate with different teams and to apply experience and “lessons learned” is essential.
Interested applicants should apply online with their CV.
All candidates should be eligible to work in Ireland