Director Regulatory/CMC

Location
New York City Metropolitan Area, New York, United States
Posted
Sep 24, 2020
Ref
2151175110
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
OVID Therapeutics

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).

SUMMARY

The Senior Director is responsible for overseeing the development and implementation of global regulatory 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.

• Lead the Global Regulatory Affairs CMC team, reporting to the head of Tech Ops and CMC.

• 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

• Lead the preparation 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

Minimum Qualifications:

• Advanced degree in a scientific discipline

• 12+ years of pharmaceutical industry experience

• Minimum of 8 years of experience working in regulatory affairs CMC

• 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

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