Description
Role:Reporting to the Senior Manager of Regulatory Affairs, you will plan, organize, and submit RA submissions in a timely manner, and be responsible for much of the overall strategy. This is an extremely exciting opportunity in Ireland offering a competitive salary as well as generous benefits. The position has strong international focus, and the right candidate should have experience with regulatory projects in a diverse range of areas.
Responsibilities:
-Prepare SOPs
-Represent the regulatory affairs department on various product teams
-Coordinate, compile and submit regulatory applications
-Organize and maintain reporting schedules for regulatory applications
-Lead associates and train them to review and prepare basic regulatory documents.Evaluates changes to regulatory documents and formulates strategies to maintain submission goals.
-Maintain awareness of regulatory changes.
Requirements:
-Minimum of BS degree in life sciences or related field, ideally an MS or advanced degree
-Minimum 8 years in pharmaceutical regulatory affairs, with an emphasis on submission strategy
-Experience with preparation and maintenance of regulatory documents for substantial changes, CE marking and international approvals / registrations.
-A strong strategic background
Start Date - ASAP
To find out more about Real Staffing please visit www.realstaffing.com
To find out more about Real please visit www.realstaffing.com