Our client is a clinical stage biotechnology company which is developing biologic therapeutics for the treatment of severe autoimmune and inflammatory diseases. They are seeking a Regulatory Affairs Consultant/Contractor who can provide strategic regulatory direction for the company’s pre-clinical and clinical-stage programs and lead an upcoming IND. Reporting into the Chief Medical Officer, you will be responsible for executing regulatory activities for a first-in-human trial and interacting directly with FDA. This remote engagement will be approximately 20 hours a week for six months.
- Develop and execute on clinical regulatory strategies for early-stage autoimmune or inflammatory disease.
- Prepare and review regulatory filings (INDs, CTAs, etc) including authorship of critical documents as needed.
- Create regulatory submission timelines in collaboration with cross functional teams
- Drive decision-making across the organization with respect to regulatory issues and strategies
- Ensuring compliance with applicable laws and regulations related to our product development and marketing activities.
- Provide regulatory guidance to product development teams for programs in development.
- Preparation of FDA or other Ex US Regulatory meeting documents, meeting requests, meeting packages, etc.
- Prepare for and lead interactions with FDA and ex US regulatory agencies.
- Provide regulatory risk assessment for projects based on regulatory precedence and product characteristics.
- Collaborate with cross-functional teams to ensure seamless integration of various components into submissions per agreed to timelines.
- Provide regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
- Serve as subject matter expert in global regulatory processes regulations, particularly with the U.S. with FDA and Ex US – EU, Australia etc..
- Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- 10+ years of Regulatory Affairs experience for development of pharmaceutical drugs and/or biologics.
- Experience with biologic therapeutics desired. Regulatory experience with immunology or inflammatory disease programs a plus.
- Strong experience with clinical regulatory strategy for programs in development.
- Successful track record of filing of INDs, CTAs, NDAs, BLAs, briefing packages, and various other important regulatory documents.
- Direct experience interacting with FDA and other health authorities. Ex-US experience highly desired.
- Strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment.
- Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management.
- Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority‐setting to meet aggressive timelines.
- Ability to work in a small, fast-paced biotech environment.
- Able to handle multiple projects and exercise good judgment in prioritizing tasks.