Senior Regulatory Strategy Consultant (Contract To Hire)

Summary of Position:

In the role of Senior Regulatory Strategy Lead, you will play a pivotal part in driving the development and successful execution of global Regulatory Strategy in support of ReCode's programs. This role requires a seasoned regulatory expert with a thorough understanding of global regulatory requirements, a strong track record of navigating complex regulatory pathways, the ability to provide strategic direction to program teams to improve regulatory success and to coordinate cross-functional teams to ensure timely and compliant deliverables in support of our innovative products.

This is a contract position (20-40 hrs/week) that can be remote.  Location flexible but preferred location on the west coast (PST time zone). Position has potential to be converted to a full-time employee.

Responsibilities:

• Develop and lead the Regulatory Strategy for our novel mRNA and gene correction therapeutics, ensuring alignment with the company's goals, timelines, and product development plans.
• Oversee the planning and execution of regulatory submissions to global health authorities, including but not limited to FDA, EMA, and other regional regulatory bodies.
• Collaborate with cross-functional teams, including R&D, clinical development, manufacturing, and quality, as well as external CROs to enable creation, review, and submission of key regulatory documents, including INDs, BLAs, and other necessary filings.
• Drive key interactions with Health Authorities and serve as the primary point of contact with regulatory agencies, representing the company's interests and facilitating interactions with regulatory authorities.
• Stay current on global regulatory guidelines, changes, and industry trends, providing insights and recommendations to the executive team.
• Identify potential regulatory risks and develop mitigation strategies to address any issues that may arise during product development.

Qualifications:

• Bachelor's degree required (advanced degree preferred) with 7-10+ years of experience in regulatory affairs within the biotechnology or pharmaceutical industry, with a proven track record of successful regulatory filings and approvals (INDs, CTAs, NDAs, MAAs and/or BLAs).
• Strong knowledge of global regulatory requirements, including FDA (CBER), EMA, MHRA, and other major regulatory authorities. Experience with non-traditional products (e.g., genetic medicines, LNPs, mRNA-based therapeutics) and rare diseases desired but not required.
• Exceptional communication and interpersonal skills, including the ability to effectively interact with regulatory agencies.
• Highly organized, detail-oriented, and capable of managing multiple projects and priorities simultaneously.
• A collaborative mindset with the ability to work effectively in a cross-functional, fast-paced environment.
• An innovative and strategic thinker, capable of providing regulatory guidance that aligns with the company's goals.

Salary Range: *$120-$150/hr

*Please note that for remote positions, salary may be adjusted for cost of living