Vice President Regulatory Affairs
Unlike other biopharma companies, my client is constantly expanding their pipeline and launching new business units, allowing employees to experience the full life cycle of a company. They are positioned to lead the charge related to many of today’s most debilitating diseases and illnesses. They are looking for a Vice President, to lead the company’s global regulatory affairs and quality assurance activities, including formulation of strategies and tactics to optimize the outcomes of interactions with global regulatory agencies. This is a great chance to join this no fear, up-for-a challenge company culture!
Responsibilities:
- Develops short and long range regulatory plans and strategies that support company’s investigational products
- Works proactively and productively with teams to identify and advance the best strategies for advancing company products.
- Responsible for informing the executive team of the regulatory status for products and significant regulator your quality issues
- Oversees interactions with FDA and other regulatory agencies
- Oversees all regulatory filings including IND/ CTA/ IMPD/ BLA/ NDA/ MAA submissions
- Provide analysis of regulatory guidance documents, regulations or directives that influence the company’s products and operations
Knowledge and Skills:
- Bachelor’s level degree required, advanced degree strongly preferred
- 12+ years industry experience with a minimum of 10+ years spent in a regulatory affairs capacity.
- Proven experience in managing investigational products and managing approvals of marketing applications
- Must have CNS experience
- Knowledgeable of US, EU and international regulatory affairs, GXP compliance and associated regulations
- Demonstrate ability and drive to build, coach, and motivate a high performing team in a growth company
- Effective process and project management skills
- Ability to demonstrate effective leadership in ambiguous and frequently changing situations