SR Director/Executive Director, Regulatory Affairs

• Location: Middlesex County, NJ
• Type: Direct Hire
• Job #38427
• Salary: $300,000.00

Seeking a Senior Director/Executive of Regulatory Affairs for our client – one of the largest specialty pharmaceutical companies in the United States.

This position is responsible for providing regulatory leadership for products in development through NDA approval as well as post-approval/life cycle management of the same. Additionally, this role is responsible for ensuring submission of complete and compliant ANDA submissions from original submission through each products’ life cycle, while serving as point of contact with the FDA.

Responsibilities:

• Functions independently as a decision maker and subject-matter expert (SME) while working collaboratively with key internal and external stakeholders to ensure high quality submissions are made to the Food and Drug Administration (FDA) to meet company goals.
• Develops and implements submission strategies for NDA (both 505(b)1 and 505(b)2) and ANDAs
• Critically reviews and approves reports and protocols from Clinical Development and documentation from Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments and internal stakeholders
• Represents Regulatory Affairs and provides regulatory advice to internal and external customers and/or partners and establishes good working relationships
• Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale
• Interprets regulations and guidance documents and provides strong regulatory leadership to project teams to ensure regulatory success
• Is overall responsible for ensuring adherence to relevant regulatory requirements and company Standard Operational Procedures (SOPs)
• Manages, mentors, coaches and develops a small team of direct and indirect reports

Qualifications:

• Advanced degree preferred AND minimum 9 years Regulatory Affairs experience in the pharmaceutical industry in positions of increasing strategic and leadership responsibility REQUIRED. A combination of equivalent education and experience may be considered. Job title and level determination will be commensurate with experience.
• Demonstrated success in managing the development of new products and filing of Investigational New Drug (INDs) and NDAs REQUIRED
• Hands on experience in multiple strategic and operational facets of pharmaceutical Regulatory Affairs (i.e., clinical, preclinical, pharmacokinetic, statistics, labeling, submissions, publishing, Chemistry, Manufacturing and Controls (CMC), global, advertising and promotion etc.) REQUIRED
• Proven track record of successful brand product submissions in the pharmaceutical industry REQUIRED
• Proven record of developing and maintaining successful working relationships with the FDA and other health authorities REQUIRED
• Experience managing and leading interactions with the FDA including meetings REQUIRED
• Demonstrated understanding of the regulatory process and technical competence in core areas of drug development REQUIRED
• Ability to analyze and interpret scientific data and regulatory guidelines REQUIRED
• Ability to influence without direct authority REQUIRED