CAREERS
| Regulatory Affairs Manager (Pharma) |
| Date: Feb 5, 2009 |
| Reporting To: Director of Regulatory Affairs |
| Department: Regulatory Affairs |
| Location: Inverin, Co. Galway |
SUMMARY:
Responsible for the preparation of regulatory submissions, for various pharmaceutical products, to worldwide markets.
PRIMARY/MAJOR RESPONSIBILITIES: - Management of regulatory submissions for pharmaceutical products for approval by the US FDA, with particular emphasis on ANDA submissions.
- Introduction of eCTD into the department.
- Participate in project teams, performing scientific and technical review on development and regulatory documentation.
- Monitor the progress of regulatory submissions, responding to queries and ensuring that registration approvals are granted without undue delay.
- Ensure adherence to schedule for maintenance of approvals, including supplements to existing approvals.
- Assess and review documentation to ensure compliance with product licences.
- Undertake general regulatory activities that interface with other departments such as Manufacturing, Product Development, Quality Control and Quality Assurance.
- Assign project work and review workload for all direct reports.
- Assist staff with their responsibilities establishing goals that will increase their knowledge and skills level.
KNOWLEDGE/EXPERIENCE:
- Educated to at least a Degree Status in one of the Life Sciences.
- Minimum of 5 years regulatory experience in the pharmaceutical industry.
- Extensive knowledge of current US regulatory requirements.
- Good communication and leadership skills essential.
Please forward cover letter and CV to careers@bionichepharma.com |
