Manager, 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 Manager of Regulatory Affairs.
This role will be responsible for developing regulatory strategy, ensuring and implementing global regulatory compliance, and preparing and managing regulatory documents, submissions and health authority interactions. In addition, this role will be responsible for identifying regulatory risks and implications for strategy and product development, implementing effective mitigation and action plans, collaborating effectively with internal and external stakeholders, and utilizing technical knowledge to effectively apply regulations and guidelines to the product development process while ensuring compliance.
Responsibilities include, but are not limited to:
- Work with the VP of Regulatory Affairs and project teams on the development and execution of regulatory strategy and operations throughout the development process.
- Develop, conduct and manage the preparation, review and submission process for global regulatory documents (e.g., orphan drug designations, INDs, Annual Reports, protocol/CMC amendments, clinical trial applications, BLAs, etc.) ensuring regulatory submissions are complete, organized, of high quality, and compliant with applicable regional regulations.
- Manage external regulatory and cross-functional experts and consultants to ensure successful regulatory submissions and strategic development opportunities.
- Monitor and ensure product-related corporate activities for regulatory compliance, including CMC, nonclinical, and clinical plans and practices.
- Manage regulatory archives and databases, both internally and with external partners.
- Monitor regulatory trends, provide risk assessments and recommendations on various regulatory scenarios, and implement mitigations with alignment from senior management.
- Maintain knowledge of existing and new regulations and guidance pertaining to clinical development, quality, CMC, etc. and advise company on requirements for compliance.
- Assist in generation and maintenance of company SOPs, work practices, company directives, initiatives and guidelines.
- Assume additional responsibilities as assigned.
Required Skills & Qualifications:
- 5+ years of regulatory affairs experience in the biopharmaceutical industry.
- Bachelor’s degree in life sciences, advanced degree highly desirable (MS, MPH, PhD or equivalent)
- Experience in oncology required; CMC, and/or companion diagnostics is a plus.
- Knowledge of regulatory submissions, marketing applications and overall drug development
- Knowledgeable in ICH/cGMP/GLP/GCP, and regulatory guidelines as applied to the entire development lifecycle of biotech and pharmaceutical companies.
- Ability to thrive and flourish in a fast paced entrepreneurial early-stage company environment that requires “hands-on” implementation, optimal use of limited resources and an ability to work closely and collaboratively with others in a small team setting.
- Must be a highly motivated self-starter, show initiative and independence, and be driven to make an important business contribution.
- Excellent collaboration, influencing and facilitation skills across functions and employee levels; treat others with utmost respect and consideration.
- Evidence of solution-oriented thinking skills; creative, strategic, flexible and able to think “out of the box”; ability to work under pressure and time constraints and easily adaptable to rapid change.
- Open minded and place high value on other’s experience and perspectives in the field of drug development, regulatory affairs and compliance.
- Demonstrated ability to participate in cross-functional teams and to achieve results through cooperation with other departments and with external consultants and partners.
- Excellent interpersonal, presentation, written and verbal communication skills.
- Strong time management and organizational skills coupled with a sense of urgency and strong work ethic.
- Proven history of the ability to work independently, remotely and as part of a dynamic team.
- Potential need to travel (U.S./ Int’l) 10% of time.
- Must be located within and authorized to work in the United States today and in the future.
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.