Associate Director, Regulatory Affairs

Flare Therapeutics is a biotechnology company pioneering a new therapeutic space with a novel approach to decipher the biology of transcription factors to develop small molecule medicines. Based on insights from the seminal work of its scientific founders, Flare’s team has uncovered ‘switch sites,’ druggable regions that are key targets for transcription factor regulation, to address mutations that cause disease. Flare’s drug discovery efforts to target switch sites has rapidly advanced, resulting in an emerging pipeline of research programs that address well-validated genetically-defined transcription factors, initially focused on precision oncology with future potential in neurology, rare genetic disorders, immunology and inflammation.

We are a collective of brilliant fires, trailblazing a path to conquer transcription factors and create cutting-edge medicines for patients. We embrace diversity in all its forms, experiences, and viewpoints. We are inspired by the unknown and willing to take risks. We are passionate about the science we pursue and compassionate about the patients it stands to benefit. And we respect, value, and believe in each other.

• Oversee all program-related regulatory submissions, which may include INDs/CTAs, Briefing Documents, Orphan Drug Applications, and NDA/MAAs. Provide hands-on-support in generation of regulatory documents, working with cross-functional teams to establish content alignment and timing of deliverables.
• Manage and directly contribute to all operational aspects of preparing compliant submissions to Regulatory Agencies and oversee publishing vendor. Manage regulatory submission timelines in accordance with project plans
• Serve as the core team representative and participate on one or more programs in Flare’s pipeline
• Provide regulatory guidance and education to program teams through interpretation of regulations, policies, and guidelines
• Maintain submission tracking information and inform program teams and management on real-time status of business-critical submissions and risk and timeline management
• Develop short and long-range regulatory strategies for Flare, working closely with both research and development colleagues, to ensure plans are in place for efficient and expedient drug development.
• Coordinate timely, high-quality responses to Health Authority questions
• Maintain regulatory files in a format consistent with internal requirements
• Provide technical regulatory review and expertise for the creation and maintenance of internal SOPs, policies and guidance documents to ensure compliance with global regulatory requirements. 
• Develop and maintain regulatory policies and procedures to ensure compliance with applicable regulations and guidelines

• You have a Bachelor’s Degree in a scientific discipline with 8 years in the pharmaceutical industry, including 5 years of regulatory affairs experience 
• You have a strong ability to interpret global regulations, policies, and guidelines (FDA, EMA, PMDA, etc.)
• You have experience developing regulatory strategy documents and contributing to clinical development plans
• You have experience as the regulatory contact for Health Authorities, and with regulatory filings, including electronic submissions, e.g., INDs, CTAs, annual reports, safety reporting, etc.
• You have excellent organizational and project management skills
• You have the ability to work in a team environment, possessing excellent interpersonal and communication skills to work effectively with other team members and departments at various levels and with CROs and external consultants

Flare is proud to foster a diverse, equitable and inclusive company culture that embraces all people; this is key to who we are, what we do and what we believe. To ensure that we continue to incorporate everyone’s perspectives and experience, we never discriminate based on race, religion, national origin, gender identity or expression, sexual orientation, age, or marital, veteran, or disability status. All your information will be kept confidential in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Flare about our openings. All resumes submitted by search firms/employment agencies to any employee at Flare via email, the internet or in any form and/or method will be deemed the sole property of Flare, unless such search firms/employment agencies were engaged by Flare for this position and a valid agreement with Flare is in place. In the event a candidate who was submitted outside of the Flare agency engagement process is hired, no fee or payment of any kind will be paid.