Description

Welcome! 

Ovid Therapeutics is a biopharmaceutical company developing medicines designed to conquer seizures with courageous science. We exist to serve and meaningfully improve the lives of people affected by epilepsies and brain disorders with seizure symptoms.

It is with curiosity, courage, and tenacity that, together, we work for meaningful change in the lives of patients and their families. With this sense of purpose and urgency we challenge the conventional and embrace the wisdom and thought that comes from diverse backgrounds and perspectives. Importantly, we understand the commitment we make to our patients, our broad community and to each other is based on the humanity that we share. 

Your Role On Our Team

The Senior Director, Regulatory Affairs is responsible for managing all Regulatory Affairs activities (nonclinical and clinical) for assigned projects.

Reporting to the Sr VP, Regulatory Affairs, Pharmacovigilance and Biometrics, this individual will be the Regulatory lead for assigned projects, responsible for establishing and implementing regulatory strategy, acting as primary contact with relevant health authorities, and representing Regulatory Affairs on project teams and to development partners.

This position is hybrid and you’ll be expected to work on site at one of Ovid’s facilities in NYC or Boston at least three days per week and attend Company-sponsored in-person events from time to time.

On any given day, you'll spend time.... 

• Develops and implements regulatory strategies to support investigational drug development and filings of INDs, CTAs, NDAs, and other regulatory applications for assigned projects
• Leads regulatory activities, including planning and reviewing of nonclinical and clinical sections of regulatory submissions for format and content
• Develops and manages regulatory submission project timelines for assigned projects
• Serves as primary contact and collaborates with external vendors and/or partners on regulatory strategic and operational issues for assigned projects
• Coordinates and prepares company responses to information requests from health authorities
• Acts as the primary company contact to health authorities for assigned investigational drugs, including leading meetings with health authorities and business partners
• Maintains in-depth knowledge/awareness of relevant federal and international and policies regarding development of investigational agents and maintenance of marketed products to optimize Ovid regulatory strategies
• Responsible for Regulatory input into product labeling, including coordinating development of product label, utilizing internal or external regulatory labeling resources
• Regulatory review of externally facing materials
• Prepares plan and internal SOPs to manage regulatory compliance and reporting requirements

Requirements

Your Expertise - minimum qualifications

• Minimum of 15 years’ experience in the pharmaceutical or biotechnology industries, with at least 10 years in progressive experience in regulatory affairs
• Must have demonstrated experience in filing INDs and annual reports
• Strong knowledge of FDA/ICH regulatory guidelines
• Broad knowledge of drug development space

Your Background and Experience - preferred qualifications

• Advanced degree in relevant scientific discipline (e.g., Medicine, Pharmacy, Chemistry, Biology, etc.) preferred
• A mix of large and small company biotech experience preferred
• Knowledge of CMC regulatory guidelines and the ability to oversee CMC regulatory consultants (as needed) is strongly preferred
• Experience within neurology and / or multiple therapeutic areas preferred
• Experience with non-US trials and filings, and/or liaising with global regulatory authorities strongly preferred
• Experience with DocCompliance and MedXview or other web-based document management/publishing software for electronic submissions preferred
• Must be able to effectively communicate at all levels of the company, as well as with external partners and regulatory authorities
• Excellent time management skills and a proven ability to work on multiple projects at any given time in a fast-paced environment
• Strong skills in planning, organizing, decision-making and problem-solving
• Demonstrated leadership and project management skills

Ovid operates in a hybrid-work model and has offices in NYC, New York and Boston, Massachusetts.  Candidates applying must be willing and able to be in the NYC/Boston office in coordination with their manager's expectations, as well as department and business needs.

The base salary range for this position is $250,000 - $285,000. The actual salary offered within the range is dependent on a variety of factors including, but not limited to , relevant experience, qualifications, skills, level offered, and performance expectations.