CAREERS

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_bioniche@mylan.com