Sr Manager, Regulatory Affairs

Sr Manager, Regulatory Affairs at Green Key Resources Sr Manager, Regulatory Affairs at Green Key Resources in Gaithersburg, Maryland Posted in 3 days ago.

Type:

full-time

Job Description:

Responsibilities :

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. Evaluate the regulatory impact of proposed manufacturing, analytical, or quality changes. Serves as the primary liaison with Health Authorities for assigned products. Provide scientific and regulatory support for analytical and bioanalytical method development and validation activities and stability programs. Keeps abreast of changing regulations and health authority actions. Ready to take on additional responsibilities as requested.

Qualifications :

Must have experience with regulatory strategy, application maintenance and eCTD authoring. Master's degree with 10+ years (or doctorate degree with 5+ years) of experience in CMC regulatory affairs. Experience in manufacturing and/or QA/QC within pharmaceutical or biotech industry. Experience in drafting Chemistry, Manufacturing, and Controls (CMC) sections within the Electronic Common Technical Document (eCTD) format involves creating, organizing, and submitting detailed technical documentation for regulatory approval. Experience in regulatory evaluation of manufacturing changes (e.g., site transfers, process, equipment) for submission to the health authorities. Knowledge of chemistry and/or biotechnology related to manufacturing and control of active pharmaceutical ingredient (API) and drug product of small molecules and/or biologics. Strong knowledge of regulatory requirements (FDA, Health Canada, EMA) for various dosage forms, including tablets, capsules, injectables, oral solutions, and ophthalmic products. General expertise in biotechnology or chemistry, in-process control, analytical testing, and validations. Experience in working with global CMOs and CROs. Ability to interpret a variety of scientific data and technical instructions in mathematical or diagram forms 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 is preferred. Knowledge of pharmaceutical product development. Knowledge of Veeva system is a plus but not required.