Global Regulatory Affairs Leader
A highly motivated and experienced professional is sought to lead the Global Regulatory Affairs team. This individual will be responsible for developing and implementing global regulatory strategies to achieve program objectives for complex projects.
The ideal candidate will have a strong background in regulatory affairs, with experience in managing teams and overseeing multiple projects. They will be able to provide strategic advice and guidance to ensure timely and efficient conduct of all regulatory projects, while ensuring compliance with global regulatory requirements.
This role offers an exciting opportunity to work on innovative products that meet the needs of underserved patients, and to contribute to the development of new therapies. The successful candidate will be a strong leader who can create a vision for the group, inspire and motivate others, and demonstrate leadership behaviors.
Key Responsibilities:
* Develop and implement global regulatory strategies to achieve program objectives
* Provide strategic advice and guidance to ensure timely and efficient conduct of all regulatory projects
* Ensure compliance with global regulatory requirements
* Lead and manage meetings and/or interactions with regulatory authorities and agency meetings
* Oversee vendor responsibility for regulatory activities and submissions related to projects within scope
Qualifications:
* MD, PhD or PharmD in a scientific discipline preferred
* 15+ years of experience in Regulatory Affairs
* Proven success in regulatory submissions
* FDA, EU, Canada, ROW, and post-marketing experience is a plus
* Previous experience in attending and leading a team to prepare for major health authority interactions
Benefits:
* Opportunity to work on innovative products that meet the needs of underserved patients
* Contribute to the development of new therapies
* Strong leadership opportunities
* Chance to work with a talented and dedicated team