The Manager, Regulatory Affairs will provide leadership within the Regulatory organization developing regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable regulations. The Manager will work collaboratively with cross functional business partners to execute global strategies, and with external regulatory authorities managing submissions for the US, Canada and European Markets.
The Manager, Regulatory Affairs is also responsible for managing staff supporting the Emerging Market (EM) strategy and is expected to bring innovative capabilities for managing EM registration and license maintenance activity, as well as staff development.
The Manager, Regulatory Affairs will maintain proficiency on regulations for assigned products and markets, provide continuing awareness on changing regulations, and dissemination of regulatory interpretations to the cross functional business teams including new product development, marketing and clinical groups.
- Serves as leadership within Regulatory Affairs organization to help drive regulatory best practices
- Promotes staff development, helping identify areas of development focus and action plans to address
- Serves as a strategic business partner working across functions to establish effective product registration strategies
- Manages Regulatory Agency interactions to expedite responses to agency queries and approval of applications.
- Reviews product labelling and promotional materials to assure compliance with regulatory requirements and consistency with product indications and classification.
- Brings vision and innovation to Regulatory Affairs registration and license maintenance activity for the Emerging Market
- Provides direction and oversight of Regulatory Affairs projects assuring business objectives are met in a timely and efficient manner.
- Bachelor’s Degree in a scientific discipline required, Advanced Degree desired
- 8 - 10 years’ experience in Regulatory Affairs, or related field
- Demonstrated working knowledge and effective implementation of applicable regulations and standards for the EU, LAA, Asia and Middle East.
- Strong oral and written communication skills
- Strong interpersonal skills – ability to work closely with people at all levels of the organization and with persons from different cultural, language and regional backgrounds to accomplish assigned job responsibilities.
- Experienced staff development and management
- Ability to execute on strategic initiatives and manage day to day deliverables
- Ability to apply new approaches to problem solving
- Demonstrated interest in and understanding of industry developments and trends
- Project management skills a plus
- Clinical Trial experience a plus
- 10% travel
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