Manager, Regulatory Affairs CMC
Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris’ passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company’s success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other and we believe in respectful, open and honest communications to help support individual and team success.
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 Manager, Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs.
The Manager, 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 RA 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. This position is an independent contributor managing projects, not people. 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 reviewsRequirements
· Bachelors degree AND minimum 6 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.