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.

Job Summary

The Director, Regulatory Affairs is responsible for providing regulatory leadership for products in development through New Drug Application (NDA) approval as well as life cycle management of the same. The incumbent serves as a key partner with Clinical Development and Research and Development (R&D) in supporting clinical programs for products in both early and late-stage development. She/he serves as point of contact with the Food and Drug Administration (FDA) for brand products and leads strategy development and execution of meetings. The incumbent also supports business development assessment of external opportunities and planning and execution of strategy for global initiatives to bring brand products to market.

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 FDA to meet company goals. She/he also leads, directs and supports planning, writing and review of all non-Chemistry Manufacturing and Controls (CMC) regulatory submissions to support original Initial New Drug Applications (INDs) and NDAs

ESSENTIAL FUNCTIONS

• Develops and implements submission strategies for IND and NDA applications
• Leads the planning, writing and review of all regulatory submissions to support pre-IND, original IND, 505(b)1&2 NDAs including FDA meeting requests and packages
• Leads and actively participates in 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 on project teams and provides regulatory advice (non-CMC) to internal and external customers
• Keeps up to date on FDA and International Council on Harmonisation (ICH) guidances and interprets/informs project teams of implications to drug development
• Creates and manages project timelines; evaluates changes to maintain submission goals and timelines; Establishes good working relationships and manage relationships with internal and external partners
• Provides feedback and coaching to others in the Regulatory Affairs Department
• Manages, coaches and mentors direct reports

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

Minimum education and years of relevant work experience

Masters degree in a science field and minimum 8 years Regulatory Affairs experience in the pharmaceutical industry in positions of increasing strategic and leadership responsibility OR Bachelors degree in a science field and minimum 9 years Regulatory Affairs experience in the pharmaceutical industry in positions of increasing strategic and leadership responsibility supporting small molecule drug development.

• Hands-on experience or support in multiple strategic and operational facets of pharmaceutical development. These areas may include, but not limited to target product profile development, clinical, pharmacokinetics, preclinical, statistics, safety reporting, labeling, submissions, publishing, etc.
• Thorough, working knowledge and understanding of small molecule development process
• Proven track record of successful product filings in the pharmaceutical industry
• Recent experience drafting documentation for regulatory applications
• Proven record of developing and maintaining successful working relationships with the FDA
• Demonstrated understanding of the regulatory process and technical competence in core areas of drug development
• Ability to analyze and interpret scientific data and regulatory guidelines
• People management experience
• Ability to influence without direct authority
• Proficiency with Microsoft Office
• Excellent verbal and written communication and skills
• Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
• Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
• Fluent in English (verbal and written)

Travel requirements

10%

Physical requirements

Office based position

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.