Angion is a clinical-stage biopharmaceutical company focused on acute kidney injury, a potentially life-threatening condition without therapeutic options. Our lead clinical asset, ANG-3777, is engineered to activate the HGF/c-MET pathway, an important mechanism in organ repair. Angion is developing ANG-3777 to meet the high unmet medical need of acute kidney injury resulting from kidney transplantation and from cardiac surgery. We are currently conducting Phase 2 and Phase 3 clinical trials with improvement in kidney function as an endpoint. Angion’s robust pipeline includes ANG-3070, an oral small molecule in development as a potential treatment for fibrosis and other severe organ damage. Learn more at www.angion.com
The Head of Regulatory Affairs will be responsible for supporting the company’s pipeline development efforts for early programs including providing an on-going evaluation of potential new therapeutic targets for diseases facilitating deep regulatory due diligence. This person also will be responsible for preparing regulatory development strategies, advise management on regulatory risk, and lead interactions with regulatory agencies on behalf of the company. This position involves both high-level strategic planning as well as hands-on responsibilities to support the growing pipeline.
Areas of specific responsibility and attention will include the following:
- Develop US and global regulatory strategies aligned with business objectives.
- Provide guidance, direction, and leadership on those strategies to the development team and senior management.
- Make strategic contributions to clinical development plans.
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings, and interface with regulatory authorities; be the primary liaison with regulatory authorities for day-to-day interactions.
- Maintain up-to-date working knowledge of US laws, regulations, and guidelines as well as familiarity with the global regulatory environment.
- Identify and collaborate with regulatory experts and consultants.
- Coordinate and prepare responses to requests for information from regulatory authorities
- Represent the regulatory function on the cross-functional development team(s).
- Establish, update, and implement regulatory policies, standards, and procedures for the Company.
- Ensure operations in are compliant with FDA, ICH, EMA, and industry standards.
- Manage the regulatory aspects of products and projects including achievement of timelines and deliverables.
- Understand electronic submission process and guide the development team in the preparation of electronic regulatory submissions.
- Author, review and/or edit documents i.e., informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports as necessary.
- Build a regulatory affairs team to support the growing pipeline in development and commercial activities.
- As the company grows, liaise with quality/compliance consultants to build a quality system for the company.
- An Advanced degree with a minimum of 15 years of industry and 10 years of regulatory experience and a minimum of 3 years of experience in a senior regulatory role.
- Previous successful regulatory approvals, ideally in the areas of nephrology and kidney disease.
- Demonstrated leadership competencies in establishing clear direction and objectives; ability to simplify complex processes and foster an environment that brings out the best in people.
- Excellent working knowledge of drug development process and knowledge of FDA regulatory requirements including:
- EU and global regulatory experience
- NDA/BLA and MAA experience
- Track record for having adopted innovative regulatory strategies for molecular entities previous approved by regulatory agencies.
- Strong strategic and analytical abilities
- Electronic submission experience
- Excellent verbal and written communication skills
- Ability to provide strong regulatory leadership on a cross-functional team
- Advanced knowledge and experience in interpretation of regulations, guidelines and precedents related to drug development.
- Experience with pediatric and rare disease indications, fast track development products a plus.
- CMC regulatory leadership and strategy experience a plus
- Excellent team-building, leadership and management skills
- Excellent listening, communication and interpersonal skills fostering team spirit
- Consistent delivery of high-quality work at all times.
- Outstanding skills in managing direct reports, vendors and others involved in regulatory affairs activities to meet corporate objectives.
- Ability to accurately project timelines and manage them across regulatory projects.
- Experience in mentoring staff to develop their skills and ensure they remain challenged professionally.
- Because Angion BioMedica is a high growth, fast-paced, small organization, the ability to be productive and successful in an intense work environment is critical. Willingness and ability to travel domestically and internationally is required.