Job Title: Senior Director/VP of Regulatory Affairs

Location: South San Francisco, CA

Company Description: We are a pre-IPO start-up in the neurological and immunological diseases space. Our mission is to develop innovative therapies that can improve the lives of patients suffering from these debilitating diseases. We have a strong pipeline of candidates that have shown promising results in pre-clinical studies and are now poised to move into clinical development.

Job Description: We are seeking a Senior Director/VP of Regulatory Affairs to join our team and lead our regulatory strategy. In this role, you will provide strategic and operational leadership for all regulatory activities related to our clinical development programs. You will also collaborate with cross-functional teams to ensure that our development programs are aligned with regulatory requirements.

Responsibilities:

• Develop and execute regulatory strategies to support clinical development programs
• Manage regulatory submissions and interactions with regulatory authorities
• Ensure compliance with applicable regulations and guidelines
• Provide guidance to cross-functional teams on regulatory requirements and strategies
• Represent the company at regulatory meetings and conferences
• Build and maintain relationships with regulatory authorities
• Develop and maintain knowledge of applicable regulations and guidelines

Qualifications:

• Bachelor's degree in life sciences or related field; advanced degree preferred
• Minimum of 10 years of experience in regulatory affairs in the pharmaceutical/biotech industry
• Strong knowledge of US and EU regulatory requirements and guidelines
• Experience leading regulatory strategy for clinical development programs
• Experience managing regulatory submissions and interactions with regulatory authorities
• Excellent written and verbal communication skills
• Strong leadership and project management skills