Sr. Manager Regulatory Affairs CMC

Our client is a well‑established, privately held pharmaceutical company with a multi‑decade legacy in the research, development, and distribution of therapies for people affected by rare and ultra‑rare diseases. The company holds one of the earliest FDA Orphan Drug Designations of any pharmaceutical company in the U.S. and continues to build on that heritage today. It differentiates itself through deep, niche expertise in CMC development and lifecycle management for complex specialty therapies — several of its currently marketed products remain the only, or one of very few, approved treatment options for the rare conditions they address. In short: a small company punching well above its weight in a therapeutic space most of the industry has overlooked. The Role They Will Play This role sits at the center of the company's CMC regulatory strategy — equal parts scientific translator, health‑authority liaison, and internal advisor on how manufacturing and quality decisions play out on the regulatory front. Day to day, this person will plan, prepare, and manage regulatory dossiers (INDs, NDAs/BLAs, IMPDs, MAAs) and lifecycle submissions, and will evaluate the regulatory impact of manufacturing, analytical, and quality changes before they reach a health authority's desk. Unlike a CMC regulatory role at a large, siloed organization, this position offers direct, end‑to‑end ownership of submissions and direct‑line access to health authorities — with far less hand‑off between strategy and execution. For the right candidate, this is a running start toward a Director‑level regulatory strategy seat: the scope is already broader than the title suggests, and the company is actively investing in the function. We are looking for a CMC regulatory affairs professional who is equally comfortable in the lab, in an eCTD authoring tool, and across the table from a health authority reviewer. Expertise in CMC regulatory strategy, application maintenance, and eCTD authoring. 10+ years' experience in CMC regulatory affairs (Master's degree) — or 5+ years with a doctorate. Exposure to manufacturing and/or QA/QC within the pharmaceutical or biotech industry. Working knowledge of global health authority requirements (FDA, Health Canada, EMA) across multiple dosage forms. BS in chemistry, biotechnology, or a related scientific field, or equivalent experience. Essential Functions Manages the planning, preparation, and submission of regulatory dossiers, including but not limited to INDs, NDAs/BLAs, IMPDs, MAAs, and life cycle management. Contributes to strategic regulatory decision‑making; evaluates the regulatory impact of proposed manufacturing, analytical, or quality changes. Serves as a primary liaison with health authorities for assigned products; provides scientific and regulatory support for analytical/bioanalytical method development, validation activities, and stability programs. Keeps abreast of changing regulations and health authority actions. Takes on additional responsibilities as requested. Specific Job Knowledge, Skill, and Ability Experience drafting CMC sections within the eCTD format, including creating, organizing, and submitting detailed technical documentation for regulatory approval. Experience with regulatory evaluation of manufacturing changes (e.g., site transfers, process, equipment) for submission to health authorities. Knowledge of chemistry and/or biotechnology related to manufacturing and control of API and drug product for small molecules and/or biologics. Strong knowledge of FDA, Health Canada, and EMA requirements across dosage forms — tablets, capsules, injectables, oral solutions, and ophthalmic products. General expertise in biotechnology or chemistry, in‑process control, analytical testing, and validations. Experience working with global CMOs and CROs. Ability to interpret scientific data and technical instructions in mathematical or diagram form to identify problems, collect data, establish facts, and draw valid conclusions. Ability to draft, manage, and coordinate assigned regulatory submissions. Knowledge of GLP and GMP compliance; prior experience with on‑site inspection preferred. Knowledge of pharmaceutical product development. Knowledge of Veeva is a plus but not required. #J-18808-Ljbffr Kaye/Bassman International