Lead - CMC 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.
At Tris, you are empowered to make an impact in the company. You will work directly with cross functional teams and senior leadership. We are a nimble organization that aspires to make data-driven decision and put them into action, and you will play a key part in this process.
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 Lead, Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs.
The Lead, Regulatory Affairs, CMC plays a leading role within a small Regulatory Affairs group. This position works within the Regulatory Affairs Submission Department and has full responsibility for planning, coordinating, writing and preparing submissions to the U.S. Food and Drug Administration (FDA) with an emphasis on CMC quality submissions. She/he functions independently, is the sole Subject Matter Expert on all CMC related issues. The primary focus will be supporting the lifecycle of the entire Tris Abbreviated New Drug Applications (ANDAs) portfolio; including both pre-approval and post-approval activities. The key responsibilities include, but are not limited to, the following:
• Preparation of CMC regulatory documents for new ANDAs and for amendments in response to comments received from the FDA during the review process
• Preparation of CMC regulatory documents for approved ANDA products including supplements, annual reports etc.
• Draft, compile and assemble high quality submission documents in Common Technical Document (CTD) format in conformance with applicable regulatory guidelines
• Interface with project team members to obtain documentation, establish timelines and ensure complete and accurate submissions are prepared according to plan
• Critically review documentation intended for submission to the FDA for internal consistency, for consistency to relevant FDA/International Conference of Harmonisation (ICH) CMC guidelines and to promote regulatory excellence
• Participate in change control process and independently advise both the regulatory reporting mechanism based on FDA regulations and CMC guidance documents and industry experience and the documentation requirements to support the proposed changes
• Maintain awareness and communicate CMC regulatory requirements to the RA department and project teams
• Interact with clinical contract research organizations (CROs) including protocol and clinical report reviews
• Bachelors degree AND minimum 5 years experience in Regulatory Affairs specifically preparing, submitting and maintaining CMC sections of applications in CTD format supporting a pharmaceutical or biotechnology company REQUIRED.
• Extensive, hands-on experience with US Regulatory Submissions (including, but not limited to: planning, coordinating, writing and preparation) REQUIRED
• Extensive, hands-on experience independently handling both pre- and post- approval ANDA submission activities REQUIRED
• Understanding of cGMP, GLP Practices and ICH guidance as they relate to pharmaceuticals REQUIRED
• Proficiency with Microsoft Word, Excel and Acrobat Professional 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.