Senior Director CMC Regulatory Affairs
Ovid Therapeutics (NASDAQ: OVID) is a New York-based biopharmaceutical company using its BoldMedicine™ approach to develop medicines that transform the lives of patients with rare neurological disorders. Ovid has a broad pipeline of potential first-in-class medicines. The company’s lead investigational medicine, OV101, is currently in development for the treatment of Angelman syndrome and Fragile X syndrome. Ovid is also developing OV935/TAK-935 in collaboration with Takeda Pharmaceutical Company Limited for the treatment of rare developmental and epileptic encephalopathies (DEE).
The Senior Director, CMC Regulatory Affairs is responsible for overseeing the development and implementation of global regulatory chemistry, manufacturing and controls (CMC) strategies for all small molecule and gene therapy product development. The Senior Director will provide regulatory CMC leadership across projects, teams and committees and will provide strategic and operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions. The Senior Director, CMC Regulatory Affairs ensures that all US and international regulatory requirements concerning CMC are met during the development of new products and during their commercial life cycle. This individual leads the planning, compilation and submission of CMC documentation to regulatory agencies and is the primary contact with Chemistry staff at FDA and other agencies for assigned projects. This individual leads the CMC Regulatory function at Ovid.
Essential Duties and Responsibilities: (other duties may be assigned)
- Provide CMC regulatory guidance on investigational projects and marketed products, including construction of CMC dossiers, submission strategies and handling of post-approval changes
- Lead the Global Regulatory Affairs CMC team, reporting to the head of Regulatory Affairs.
- Design, develop, and implement regulatory CMC strategy across all pipeline and commercial projects
- Deliver regulatory strategy objectives for including operational risk management
- Work collaboratively across functions and teams to develop and implement regulatory CMC strategies
- Develop and maintain relationships with health authorities and lead the preparation of health authority interactions related to CMC issues; responsible for direct communication between Ovid and regulatory authorities on all CMC-related issues; interacts with senior-most CMC regulatory staff at regulatory authorities as needed
- Lead the preparation and assists in the writing of high-quality CMC sections for regulatory submissions including for INDs, IMPDs,), US NDA, MAAs, and briefing packages.
- Approve CMC regulatory documents to support regulatory submissions using industry best practices and internal Ovid Therapeutics practices.
- Develop regulatory strategies and tactics integrated with cross-functional project teams to facilitate timely submissions and approvals
- Provide regulatory expertise and serve as internal consultant on relevant global regulations and guidelines, current regulatory environment and regulatory precedent
- Assess project plans and timelines and assign and manage internal and external teams effectively to ensure projects are appropriately prioritized and goals are met
- Recognized internally and externally as an expert small molecule and gene therapy regulations, guidelines and precedents related to pharmaceutical development
- Assists with talent recruitment and leads a highly motivated, efficient and effective team
- Bachelor’s degree in a relevant technical, scientific discipline required; advanced degree strongly preferred
- Minimum of 12 years’ experience in a scientific or technical roles in the pharmaceutical or biotechnology industry
- Minimum of 10 years of progressive experience working in a CMC regulatory function (e.g., a leadership role in CMC development work conducted per ICH guidelines, in authoring Module 3 CMC documents, in addressing FDA requests for CMC information, etc.)
- Minimum of 7 years management experience preferred
- Proficiency in regulatory environments including FDA, EMA and ICH
- Experience in leading CMC submission preparation and Health Authority interactions
- Strategic thinking and strong problem-solving skills
- Strong interpersonal skills and the ability to communicate effectively cross-functionally
- Strong oral and written communication skills
- Sound understanding of CMC and GMP related issues.
- Strong sense of planning and prioritization, and the ability to work with all levels of management in a matrix environment
- Proven ability to work with interdisciplinary teams and dealing with unfamiliar situations
Job posted: 2020-11-03