Vice President of Regulatory Sciences

Strand Therapeutics is a clinical stage biotechnology company seeking a Vice President of Regulatory Sciences to manage and lead all regulatory efforts for the organization. The successful candidate will be responsible for developing and driving the regulatory strategy for clinical stage lead asset and other candidates at the pre-clinical development phase.

Requirements

• Bachelor's degree in a scientific discipline required, with a preference for a Master's, PharmD, PhD, or other Advanced Degree preferred
• 15-20+ years of regulatory strategy experience in biotech
• Experience working in a smaller, fast-paced environment highly preferred
• Excellent written and spoken communication skills
• Agile and flexible with problem-solving and innovative mindset in developing regulatory strategy
• Extensive experience with the development and preparation of regulatory submissions including briefing books, INDs, and BLAs (including expedited pathways) required
• Regulatory experience within the field of oncology required, with mRNA and gene therapy experience being highly preferred. Experience with rare diseases is a plus
• Proven track record of successfully partnering with and serving as the primary point of contact to regulatory agencies such as CBER is a must
• Solid knowledge of FDA, EMA, and ICH guidelines and regulations
• Prior interactions and experience with global health authorities such as EMA, PMDA, and TGA is a plus
• Strong project management skills, with proven track record of delivering high impact results
• Collaborative mindset with strong interpersonal skills with the ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization
• Strong organizational and time management skills

Benefits

• Top-notch benefits package (health, dental, life, open PTO, onsite lunch catering, commuter support, and more)
• Work/life flexibility and integration
• Opportunity to work closely with the founding team and be a part of the growth strategy of the company