Head of Regulatory Affairs (Remote)
It takes a team to reach the summit.
Join us to build a future in which each patient has access to the right physicians, the right tests, and the right therapeutics to treat their individual tumor.
Elevation Oncology, a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers has an opening for an experienced Head of Regulatory Affairs.
Reporting to the VP Clinical Development/CMO, you will be responsible for leading the regulatory activities at Elevation Oncology by acting as a liaison between our company and regulatory authorities/agencies, ensuring that our product(s) are developed, manufactured and distributed in a compliant manner. Initially, this role will be as an individual contributor, but as the company grows we would anticipate advancement in this position.
- Develop and implement strategies for timely submission of all required regulatory documents. Ensure science-based preparation of all applications.
- Working closely with other company leadership, ensure that our practices conform to agency requirements by establishing internal documentation, control and validation procedures.
- Act as primary point-of-contact with FDA and other regulatory agencies.
- Provide Regulatory guidance for product development and ongoing lifecycle management.
- Working with Clinical Development, create clinical trial designs, protocols and procedures that meet regulatory requirements. Review data and results to ensure protocols are followed.
- Manage all regulatory aspects of ongoing projects and serve as an internal SME for other staff.
- Provide expertise in translating regulatory requirements into practical, workable plans.
- Review data from company trials to ensure protocols are in place and followed.
- Responsible for leading and preparing for regulatory inspections, submissions and
- Additional responsibilities as assigned.
Required Skills & Qualifications:
- Bachelor’s degree in life sciences or directly related field required, Master’s degree, PhD preferred. RAC accreditation is an advantage.
- Approximately ten (10) years of directly relevant experience in the biopharmaceutical industry, including at least three years at a senior/strategic level.
- Proven hands on experience with the development of precision oncology products requiring companion diagnostics (Cdx) strongly preferred. Extensive knowledge of applicable government regulations (i.e. FDA, EMA).
- Ability to inform and educate managers and department heads on regulations and polices that require compliance.
- Excellent written and verbal communication, analytical and problem-solving skills.
- Effective strategic planning skills.
- Some US/International travel maybe required for manufacturing operations and clinical trial site inspections.
- Must be located within and authorized to work in the United States today and in the future.
This is a senior level position and starting compensation will be based on the experience level of the selected candidate.
Life at Elevation Oncology
Our values lay the foundation for the road ahead:
INTEGRITY: We’re committed to identifying and targeting the genomic targets that can make the most meaningful difference to a patient, no matter how rare. Each tumor is unique, and every patient deserves access to a drug that is made with their tumor in mind, whether made by Elevation Oncology or an industry peer.
COMMUNITY: We celebrate the unity in our shared mission and the diversity of our strengths both as individuals in a team, and as a company in a vibrant precision medicine community. We actively seek and nurture effective collaborations and strive to be a trustworthy corporate citizen.
ADVOCACY: We advocate for the widespread adoption of genomic testing and a cooperative effort supporting patient awareness and education. We believe that only as a unified industry can we can best provide our patients with a clear path forward.
If you share our beliefs and are interested in helping to further our mission, send your resume or CV to firstname.lastname@example.org and tell us how you can help. We look forward to meeting you!
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.