Director of Regulatory Affairs
Apply NowCompany: Avance Care
Location: Jersey City, NJ 07395
Description:
Overview
Director of Regulatory Affairs
The Director of Regulatory Affairs will oversee and manage all regulatory activities within Sequel Pharma, providing leadership and strategic direction to ensure successful product approvals and compliance with regulatory standards. The role involves high-level interactions with regulatory consultants and regulatory agencies and requires an understanding of global regulatory environments pertaining to the pharmaceutical industry.
Responsibilities
Key Responsibilities:
Qualifications
Qualifications:
Sequel Pharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, gender identification, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
Location: REMOTE
#LI-DNI
Director of Regulatory Affairs
The Director of Regulatory Affairs will oversee and manage all regulatory activities within Sequel Pharma, providing leadership and strategic direction to ensure successful product approvals and compliance with regulatory standards. The role involves high-level interactions with regulatory consultants and regulatory agencies and requires an understanding of global regulatory environments pertaining to the pharmaceutical industry.
Responsibilities
Key Responsibilities:
- Develop and execute comprehensive regulatory strategies to support the development and commercialization of the company's pharmaceutical products
- Coordinate, manage, and direct the preparation and submission of regulatory filings, including NDAs, BLAs, MAAs, and any required post-marketing submissions
- Serve as the primary liaison with regulatory authorities, managing communications and negotiations
- Lead the company's regulatory intelligence efforts, fostering realtionships that keep the company informed of regulatory trends, changes, and emerging requirements
- Collaborate with senior leadership and cross-functional teams to align regulatory strategies with the company's business objectives
Qualifications
Qualifications:
- Advanced degree in a scientific discipline (Pharmacy, Chemistry, Biology, etc) Pharm D. degree preferred
- 5+ years of experience in regulatory affairs, with a proven record of product approvals
- Working knowledge of global regulatory requirements, including FDA, EMA, and other international agencies in regulated markets
- Strategic thinker with excellent problem-solving skills
- Exceptional written, oral, and interpersonal skills and able to work within a collaborative environment
Sequel Pharma provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to religion, race, creed, color, sex, sexual orientation, gender identification, alienage or citizenship status, national origin, age, marital status, pregnancy, disability, veteran or military status, predisposing genetic characteristics or any other characteristic protected by applicable federal, state or local law.
Location: REMOTE
#LI-DNI