Senior Regulatory Strategy Consultant (Contract) - ReCode Therapeutics

Who We Are:

ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s proprietary Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs, tissues and cells implicated in disease, enabling improved efficacy and potency. ReCode’s lead programs include RCT1100 for the treatment of primary ciliary dyskinesia caused by pathogenic mutations in the DNAI1 gene, and RCT2100 for the treatment of the 10-13% of cystic fibrosis patients who have Class I mutations in the CFTR gene and do not respond to currently approved CFTR modulators. RCT1100 and RCT2100 are inhaled disease-modifying mRNA-based therapies formulated using the SORT LNP delivery platform. ReCode is expanding its pipeline to develop potential therapies for other rare and common genetic diseases, including musculoskeletal, central nervous system, liver and infectious disease indications.

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). 

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: *$130-$160/hr

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

Benefits Offered for Full-Time Employees: 

• No premium cost for employees - 100% subsidized by ReCode for full-time employees
• Company 401k contribution
• 15 days of company paid holidays, including a holiday shutdown (usually the last week of the year)
• Mental health support for employees & their families
• FSA available, including a lifestyle spending account subsidized by company
• Employee discounts at hotspots

ReCode Therapeutics (www.recodetx.com) offers a competitive compensation/benefits package with a friendly, collaborative culture that values employee engagement and ongoing career development.

ReCode Therapeutics is an Equal Opportunity Employer.