Senior Regulatory Strategy Consultant (Contract to Hire) - ReCode TherapeuticsView Company Profile
- Job Title
- Senior Regulatory Strategy Consultant (Contract to Hire)
- Job Location
- Menlo Park, California, United States
- Job Description
Who We Are:
We are a clinical stage company powering the next wave of genetic medicine through superior delivery with our next-generation lipid nanoparticle delivery platform. Our mRNA and gene editing therapeutics have the potential to directly replace or address underlying genetic mutations in a vast range of diseases starting with primary ciliary dyskinesia and cystic fibrosis. Our selective organ targeting (SORT) LNP platform is uniquely differentiated to enable the delivery of diverse genetic payloads to tissues beyond the liver.
At ReCode, we bring a unique blend of rigor, creativity, and curiosity to our high-hurdle mission. Our team is uniquely positioned to tackle this challenge, given our extensive experience in lipid nanoparticle delivery, mRNA design and optimization, mRNA manufacturing, gene editing, and rare disease drug development. We are a high performing, highly functional organization with a culture that is caring and strives to enable every member of our team to thrive.
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.
- 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.
- 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
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.
ReCode Therapeutics Headquarters Location
ReCode Therapeutics Company Size
Between 50 - 100 employees
ReCode Therapeutics Founded Year
ReCode Therapeutics Total Amount Raised
ReCode Therapeutics Funding RoundsView funding details