Sr. Director, Regulatory Affairs
Founded in 2000, Tris Pharma, Inc. (www.trispharma.com) is the 3rd largest specialty pharmaceutical company in the United States. With our intense focus on the application of physical chemistry in biological systems, coupled with the requirements of manufacturing and market demands, we have grown our employee base over 250% in the past three years. Specifically, we are engaged in research, development, and manufacturing of both OTC and Rx branded products and specialty generic products. Our mission is to understand the science driving the delivery of drugs into the human body; develop and bring to market products that add value to our customers and patients and provide a benefit to our company, employees and society at large. To support our expectations of continued growth Tris is expanding the Regulatory Affairs team at our Monmouth Junction, NJ facility and has an opening for an experienced SR Director, Regulatory Affairs.
The Sr. Director, Regulatory Affairs is responsible for providing regulatory leadership for products in development through NDA approval as well as post-approval/life cycle management of the same. Also responsible for ensuring submission of complete and compliant ANDA submissions from original submission through each products’ life cycle. Serves as a point of contact with the Food and Drug Administration and leads strategy development and execution of meetings with the FDA. Supports business development assessment of external opportunities. Supports planning and execution of strategy for global initiatives to bring Tris brand products to market as necessary. This is a hands-on role in addition to being a leadership role.
The incumbent 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.
· Is overall responsible for ensuring adherence to relevant regulatory requirements and company Standard Operational Procedures (SOPs)
· Develops and implements submission strategies for NDA (both 505(b)1 and 505(b)2) and ANDAs
• Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support original IND, 505(b)1, 505(b)2, ANDA and Data Master Files (DMF) submissions including FDA meeting requests and packages
• Responsible for creating occasional communications to FDA and for conducting regulatory assessment and advising submission category recommendation for some change controls
• Serves as a point of contact with FDA, leads meetings with the FDA and other Health Authorities as required
• 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
• Manages, mentors, coaches and develops a small team of direct and indirect reportsRequirements
Special knowledge or skills REQUIRED
Advanced degree preferred AND minimum 9 years Regulatory Affairs experience in the pharmaceutical or biotechnology industry in positions of increasing strategic and leadership responsibility REQUIRED. A combination of equivalent education and experience may be considered .
• Hands on experience in multiple strategic and operational facets of pharmaceutical Regulatory Affairs (i.e., Chemistry, Manufacturing and Controls (CMC), clinical operations, preclinical, pharmacokinetic, statistics, labeling, submissions, publishing, global, advertising and promotion etc.) REQUIRED
• Proven track record of successful brand and generic product submissions in the pharmaceutical or biotechnology industry REQUIRED
• Demonstrated success in managing the development of new products and filing of Investigational New Drug (INDs) and NDAs 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
Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI