Senior Manager, Regulatory Affairs

Benefits Offered

401K, Dental, Life, Medical, Vision

Employment Type

Full-Time

"We deliver innovative treatments to improve the lives of individuals suffering from neuropsychiatric, neurologic and other disorders"

Intra-Cellular Therapies Inc. is a publicly traded biopharmaceutical company headquartered in New York City. Founded on Nobel-prize winning research, we launched our first commercial product in CNS in 2020 and received approval for an expanded indication in 2021. Currently celebrating our 22nd anniversary, we have a strong pipeline with projects in preclinical development stage through Phase III. We celebrate science, welcome curiosity, expect collaboration and demand integrity and respect in all we do, create and deliver.

We are actively recruiting for a Senior Manager, Regulatory Affairs who will lead the development and execution of regulatory strategies through a program's lifecycle.

Responsibilities:

• Provide regulatory strategic direction and support for assigned development programs

• Serve as the primary point of contact with FDA for assigned applications

• Collaborate with cross-functional teams to ensure product compliance throughout the development lifecycle

• Manage regulatory submissions, including planning, preparing and reviewing documents

• Lead cross-functional teams for FDA meetings/interactions, including planning, document development, and meeting execution activities

• Lead in the preparation of new IND/sNDA/NDA applications

• Lead the maintenance of IND's throughout the life of the studies

• Participate in Study Teams and identify relevant regulatory considerations

• Oversee the compiling and submitting compliance reports to FDA for IND's and NDA

• Maintain and track the timely submission of compliance reports and regulatory commitments

• Conduct research to support regulatory intelligence activities

• Complete all company and job-related training as assigned within the required timelines

• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice

Requirements:

• Bachelor's degree required. PharmD preferred.

• 1-2+ years of Regulatory Affairs experience in a pharmaceutical company OR completion of a Post-PharmD Fellowship in Regulatory Affairs

• Regulatory Affairs strategy experience as opposed to operations, labeling, CMC or ad promo is preferred

• Experience speaking with or being a liaison to the FDA is strongly preferred

• Excellent oral and written communication skills

• Detail oriented, hard-working, passionate person who goes the extra mile; a high-level of self-motivation and professional commitment

• Ability to work collaboratively and build cross-functional relationships with both internal and external stakeholders

• Must be able to perform all essential functions of the position, with or without reasonable accommodation.

Intra-Cellular Therapies is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, disability or any other legally protected status.

Senior Manager, Regulatory Affairs: Base Salary Range $120,000 - $150,000