Director/Senior Director, Regulatory Affairs
It takes a team to develop innovative cancer therapies.
We are experienced oncology drug developers united by a shared passion for identifying true selective cancer therapies that will illuminate a clear treatment pathway for our patients. We have an opening for an experienced Director/Senior Director, Regulatory Affairs.
Reporting to the CMO, 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. As Elevation Oncology continues to grow, there will be more leadership opportunities for this position to work closely with the company’s CMO who is dedicated to mentoring and sharing in the overall strategic direction for clinical and pre-clinical assets.
- Plan, manage, and execute regulatory activities related to assigned projects that span technical areas including clinical, non-clinical, and CMC with minimal supervision
- Prepare regulatory development plans for assigned projects and establish/manage regulatory timelines
- Responsible for the planning and preparation of content for submissions to Regulatory Agencies (e.g., INDs, CTAs, meeting requests and briefing books, IND safety reports, annual reports) and coordinate responses to Regulatory Agency requests for assigned programs
- Contribute to the regulatory strategy determination along with the team based on clinical trial data, current regulations, and regulatory landscape of competitive products
- Represent Regulatory to other functions; Provide updates to Management and internal company meetings including key Regulatory milestones
- Review all Regulatory Agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards. Ensure science-based preparation of all applications
- Work closely with company leadership, ensure that company practices conform to Regulatory Agency requirements by establishing internal documentation, control and validation procedures
- Work with Clinical Development; provide input to clinical trial designs, protocols and procedures that meet regulatory requirements. Review data and results to ensure protocols are followed
- Act as primary point-of-contact with FDA and other Regulatory Agencies
- Provide expertise in translating regulatory requirements into practical, workable plans
- Engage external regulatory consultants for strategy advice and operational support
- Other duties as assigned
- B.S. or graduate degree, preferably in Biological/Life sciences. Certification in Regulatory Affairs (RAC) is a plus
- 10+ years of regulatory affairs experience in drug development and product registration activities within the pharmaceutical or biotech industry in multiple phases of development; both big and small company experience is preferred
- Evidence of being a critical strategic thinker who is solution oriented with the ability to think outside of the box; preference for demonstration of such mindset within rare disease programs
- Full functional knowledge of regulatory requirements (regulations, directives, and guidance/guidelines) pertaining to the development and registration of drug products in multiple ICH regions. Understanding requirements for biologics especially for antibody drug conjugates (ADCs) is a plus
- Ability to set priorities, work independently, and deliver results in a timely manner and ability to adapt and react to new information or changing priorities
- Strong organizational and planning skills, and ability to communicate effectively and efficiently to multiple audiences
- Experience in working with broader team on interpretation of clinical data
- Hands-on experience on the submission of IND, NDA, response development to FDA’s review questions, and labeling development or update
- Working experience with international partners
- Must be located within and authorized to work in the United States today and in the future
- Ability to thrive in a virtual work environment with some company-related travel (25%)
Elevation Oncology is focused on the discovery and development of selective cancer therapies to treat patients across a range of solid tumors with significant unmet medical needs. We are rethinking drug development by seeking out innovative, selective cancer therapies that can be matched to a patient’s unique tumor characteristics.
Elevation Oncology is an equal opportunity employer and encourages applications from all individuals.
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