Regulatory Affairs Director Role
This Senior Director, Regulatory Affairs CMC position is a key role in the development and implementation of global regulatory strategies for all development-stage programs and marketed products. The successful candidate will be responsible for developing and advising on CMC regulatory strategies to secure and maintain market access for products.
Main Responsibilities:
* Provide strategic and operational regulatory direction and mentorship on projects including CMC regulatory strategies, requirements, and risk assessments.
* Built partnerships with senior stakeholders to ensure that strategic business goals are met through knowledge sharing and expertise.
* Articulated complex Regulatory CMC issues and supported global development and commercialization of programs.
* Overseen preparation and submission of documentation to support registration packages throughout the world.
Requirements:
* A Bachelor's degree in a scientific field with 15+ years of relevant experience in Regulatory in the pharmaceutical/biotech industry.
* Extensive experience in CMC Regulatory including IND/CTA, NDA/BLA/MAA, lifecycle management, and interactions with Health Authorities.
* Strong business acumen and ability to make sound decisions contributing positively to the business.
Benefits:
* Generous vacation time and public holidays observed by the company.
* Long-term incentive and Employee stock purchase plans or equivalent offerings.
* Fitness reimbursement.