This growing, global biopharmaceutical company is developing and commercializing innovative treatments for patients with rare and orphan diseases. They are seeking a Regulatory Affairs Manager or Senior Manager who can lead regulatory activities for approved products and support programs in development. You will work closely with cross-functional teams and interact directly with US health authorities. This company offers competitive compensation, excellent employee benefits and a patient-focused company culture. Now is an exciting time to join this innovative organization and improve the lives of patients in need!
- Plan and manage regulatory activities for approved rare disease products and new programs in development.
- Manage the development, assembly, and timely submission of INDs, NDAs and other dossiers, as required for investigation and registration of products in the US and Canada.
- Ensure regulatory submissions for assigned projects, in both the investigational and commercials stages, are maintained in compliance with regulatory requirements.
- Participate on cross-functional project teams and provide expertise on regulatory matters.
- Apply knowledge of regulatory requirements to the review of scientific documentation intended for submission to regulatory authorities to ensure compliance with FDA requirements.
- Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate, based on assigned products and projects.
- Collaborate with regulatory colleagues from other regions to ensure global acceptability of planned US strategies.
- Coordinate responses to FDA or Health Canada with Regulatory management and cross-functional teams.
- Collaborate with Regulatory Operations to ensure clear understanding of submission content plans, timelines, and allowable submission windows; perform publishing QC for assigned submissions.
- Assist with review of labelling. Liaise with supply chain to ensure initiation and preparation of local labelling in support of clinical studies as well as commercial product (e.g., package insert, medication guide, instructions for use, packaging components)
- Support archive management for all regulatory documentation to ensure that archiving is being maintained in accordance with internal SOPs.
- Bachelors in a scientific discipline; advanced degree (MS, PhD, Pharm D) preferred.
- 5+ years of experience in Regulatory Affairs for pharmaceutical drugs and/or biologics.
- Direct experience in preparing regulatory submissions (INDs, CTAs) required. Experience with Marketing Applications (NDA, BLA, and/or MAA) a plus.
- Rare disease experience a plus but not required.
- Experience with CTD/eCTD submissions.
- Experience working with and responding to FDA. Exposure to Canadian regulatory requirements is a plus.
- Working knowledge of FDA and ICH regulatory guidance and regulations. Understanding of FDA structure and function.
- Working knowledge of regulations related to drug development including GCP, GLP, and GMP regulations and understanding of the pharmaceutical product lifecycle.
- Outstanding written and verbal communication skills
- Ability to work independently with minimal daily supervision
- Must be a collaborative team player who is comfortable wearing many hats in a small biotech environment.
Note: Our client cannot support an H1B visa or transfer. All candidates must be authorized to work in the United States.