Director of Regulatory Affairs
Cognito Therapeutics, Inc.
Location
Cambridge, MA | United States
Job description
Role: Director of Regulatory Affairs, Cognito Therapeutics, Inc.
Location: Boston, or Remote USA, Full-time
Company Description Cognito Therapeutics, Inc. is a venture-backed (Morningside Ventures, FoundersX) company translating scientific findings from MIT into therapeutic approaches for Alzheimer's disease and other neurodegenerative conditions. We received FDA Breakthrough Device Designation based on our Phase 2 data that showed preservation of both brain function and structure in Alzheimer's patients. Our device is in a pivotal study for first-line treatment of Alzheimer's, with potential expansion into Mild Cognitive Impairment (MCI) and Parkinson's Disease. We are a fast-moving, highly motivated team with a bold mission of bringing a novel therapy to the millions of patients in the world suffering from neurodegenerative diseases. With our patented gamma stimulation technology, we are committed to developing a pipeline of non-invasive device-based therapies.
About the Job The Director of Regulatory Affairs will be responsible for defining and implementing the regulatory strategy for Cognito Therapeutics, Inc.. Working closely with the Regulatory and Quality team members as well as Engineering, Product, and Commercial teams to prepare regulatory submissions (authoring, timeline planning, etc.), to support and conduct regulatory activities necessary to ensure the successful preparation and filing of regulatory submissions. Establishes and maintains department regulatory processes. The individual will be responsible for developing collaborative and productive partnerships internally, as well as externally with contract research/manufacturing organizations, consultants, and other vendors as required.
Roles and Responsibilities - Provide strategic regulatory leadership for development teams.
- Collaboratively develop regulatory strategies to support nonclinical and clinical activities across development programs.
- Conduct regulatory research and analysis and develop and communicate recommendations.
- Lead the annual brand planning process and ongoing measurement of brand health and financial performance.
- Manage interactions and communications with FDA and ex-US regulatory authorities.
- Ensure the company is adhering to all applicable government regulations, submission regulations, and guidelines.
- Ensure project team colleagues, management, and partners are informed of developments that may affect regulatory success. Provide solutions to prevent the recurrence of issues.
- Monitor changes in regulatory requirements and medical innovation in the relevant therapeutic areas; insightfully assess their potential impact to educate and inform project team(s) and leadership decisions.
- Identify potential regulatory risks associated with the strategic and operational regulatory plans; propose options to mitigate and communicate these in a timely, efficient manner.
Qualifications - Minimum Bachelor's degree with at least 10 years of Regulatory Affairs experience in a medical device and/or biopharmaceutical company with a proven record of significant regulatory experience and accomplishments.
- At least 8 years in a management role overseeing individuals in a high-performing team environment.
- Excellent writing skills as they relate to the preparation of regulatory documents.
- Excellent interpersonal skills with strong oral/written communication and presentation skills.
- Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.
- Good judge of risks and a keen ability to analyze options and manage outcomes.
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