What are the responsibilities and job description for the Director, Regulatory Affairs position at Ventus Therapeutics?
About us :
Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying leading-edge structural biology and computational chemistry tools to create novel small molecule medicines for challenging targets in immunology, inflammation, and neurology.
Our proprietary drug discovery platform, ReSOLVE, gives us the ability to discover and develop medicines through unique insights into protein targets and to create dynamic blueprints that can guide the development of differentiated therapies at a fast pace. We aim to use the ReSOLVE platform to improve the way medicines are discovered and developed, with the ultimate goal of restoring the health of people facing serious illnesses.
Position overview :
The Director of Regulatory Affairs will report to the SVP of Regulatory and Quality. The individual in this role is responsible for developing and implementing regulatory strategies, interfacing with regulatory agencies, identifying and managing regulatory risks, implementing the regulatory aspects of clinical trials, and developing and submitting regulatory documents, and therefore can have a significant impact on the company’s trajectory.
Key Duties and Responsibilities :
- Executes preparation of regulatory documentation including authoring and / or reviewing and maintenance of initial applications, routine amendments, responses to information requests, meeting background materials / scientific advice to support interactions with
- Health Authorities) HAs, annual reports, IND safety reports / DSURs, and correspondence with HAs.
- Leads cross-functional team discussions and works to gather consensus (e.g., leads meetings of regulatory submission documents such as HA briefing documents / scientific advice and meeting requests).
- Leads, implements, and executes regulatory strategy (Clinical, Non-clinical, CMC) and global submission plans for early and / or late-stage projects.
- As a strategic member of project teams across indications and programs, designs and develops regulatory (clinical, non-clinical and CMC) strategic options
- Proactively defines and identifies regulatory risk and mitigation plans in support of product development plans.
- Under the guidance of the SVP of Regulatory and Quality
- Be the point of contact with regulatory agencies
- Plan and lead meetings with regulatory authorities
- Author and oversee the preparation of responses to all regulatory authority queries
- Maintains strong relationships with cross-functional internal colleagues, and regulatory agencies, external CROs, regulatory consulting groups, and other third parties.
- Participates in cross-functional teams, providing regulatory feedback and support.
- Maintains up-to-date working knowledge of current FDA, EMA, MHRA and Ex-US regulations and guidelines as well as familiar with global regulatory environment. Proactively assesses and communicates impact, potential risks, and potential mitigations.
- In conjunction with Regulatory Operations, develops processes and utilizes tools for creating, maintaining, tracking, and communicating regulatory submission and publishing plans, and timelines to internal stakeholders and external vendors.
- Leads and / or participates in regulatory, technical and clinical operation initiatives to establish and improve processes and ways of working, keeping current with approaches to regulatory strategy, dossier strategy, and submissions.
Requirements :
