Director, Regulatory Affairs
EnVivo is developing its broad pipeline of diverse programs with a focus on leveraging novel mechanisms of action to treat CNS diseases like schizophrenia and Alzheimer’s disease in new ways and from multiple angles. Our approach is multi-target and multi-program by design - with no therapies currently available to treat the underlying causes and mechanisms of many CNS diseases, the scientific expertise and drug discovery ability to pursue a variety of disease targets is key. EnVivo has created a diverse pipeline of promising drug programs with mechanisms that could alter the progression of disease or provide sustained improvement in function to patients with serious CNS disorders, including Alzheimer’s disease, schizophrenia and others.
We are well financed and strongly positioned to develop and commercialize our own programs. Our primary goal is to rapidly and effectively translate our promising research and development programs into safe and effective CNS therapies for patients. As we also work to build an integrated drug company, our strategy is to retain a meaningful lead role in development and commercialization of our programs in certain indications and geographies, while also seeking to strategically partner our programs in order to fully realize the promise and potential of our pipeline.
The position is responsible for providing Regulatory Affairs direction for EnVivo’s products. They will author, review and edit regulatory submissions, develop regulatory strategy in conjunction with business objectives and functional management, and drive timelines and deliverables related to submission documents. Additionally the position will provide guidance, direction and leadership to others in the regulatory group. The director of regulatory affairs must be capable of making strategic contributions to clinical development plans and also be expert at interacting with CROs.
Job Objectives and Tasks:
- Regulatory operations liaison to internal program teams
- Author, review and/or edit documents i.e., informed consents, Investigator’s Brochures, study materials, essential documents, presentations, and reports
- Demonstrated leadership competencies in establishing clear direction and objectives; can simplify complex processes; foster an environment that brings out the best in people
- Provide oversight and direction for regulatory affairs
- Develop US and global regulatory strategies
- Maintain up-to-date knowledge of US laws, regulations and guidelines as well as familiarity with the global regulatory environment
- Generate correspondence to regulatory authorities on specific projects
- Work with external consultants on regulatory issues
- Perform other duties as assigned
- Advance degree in scientific discipline with 8-10 years of regulatory experience or Bachelor’s degree with 15 or more years of experience
- Solid working knowledge of drug development process and knowledge of FDA regulatory requirements; EU and global regulatory experience desirable
- NDA and MAA experience and proven ability to lead collaborative teams
- Strong strategic and analytical abiltities
- Excellent verbal and written communication skills
EnVivo offers a very competitive compensation and benefits package to full-time employees that includes employee stock options, healthcare and dental coverage, life and AD&D insurance, and a 401(k) plan.
Please send resumes to one of the following:
Via fax: 617-225-4267 Via email: email@example.com