Vp/Svp Regulatory Affairs

Our client is a strong and diversified gene therapy company with a proprietary platform and a focus in the neuro and rare disease development space. They have both wholly owned as well as partnership programs at various stages of preclinical and clinical development. They are seeking a creative and experienced regulatory leader who will be able to propose creative strategies for them to achieve commercialization in the most efficient manner possible.

The VP will, be responsible for devising and implementing regulatory strategy and providing leadership oversight for all regulatory submissions, regulatory compliance, regulatory advice, and counseling in all areas of development. They will be reporting to the CMO

Responsibilities

• Formulate a compelling strategy and drive the execution of tactical plans to achieve regulatory goals.
• Provide direct regulatory oversight to all applicable pre-clinical, clinical and CMC activities.
• Oversee all regulatory submissions from pre-IND to BLA filings as well as all filing with health authorities on a global basis.
• Present and communicate with key internal and external stakeholders regarding regulatory strategy and relevant issues.
• Provide interpretation of FDA and other regulatory guidelines or issues to leaders and drive interactions between the Company and regulatory authorities.
• Monitor regulatory landscape and advise on changing regulatory developments and strategic impact as well as mitigate any risks
• Develop and design robust regulatory structures, processes, and procedures.

Experience

• In-depth understanding of drug development and product commercialization preferred.
• Ability to provide innovative strategies in complex regulatory landscapes preferred.
• Experience leading, designing, writing, and submitting regulatory filings with BLA filing experience required. Previous product approval preferred.
• Experience in neurology/rare disease and gene therapy areas preferred.
• BS degree focusing on life sciences or related area; advanced degree e., MS, PharmD, PhD, MD) preferred.
• Excellent oral and written communications skills with the ability to compellingly influence.
• Demonstrated enterprise leader with a minimum of 5 years functional leadership and people management.
• Minimum 10 years in Regulatory Affairs strategy within the pharmaceutical industry.
• Proven sense of urgency in managing project teams to meet goals and deadlines is required.
• Demonstrated ability to build cross-functional relationships and work collaboratively is a must.
• Global filing experience preferred.
• Previous interaction with CBER required