Regulatory Affairs Project Manager

Job SummaryWe are seeking a highly motivated and experienced Regulatory Project Manager to join our team within the Pharmaceutical industry. The ideal candidate will have a deep understanding of regulatory affairs, drug development, and product registration processes, with a strong focus on biologics, including monoclonal antibodies, gene therapies, vaccines, and biosimilars. This individual will be responsible for managing the regulatory strategy, submission process, and overall project lifecycle to ensure compliance with all relevant regulations, as well as maintaining communication with health authorities globally.Key Responsibilities:Develop, implement, and manage regulatory strategies for biologics products, ensuring alignment with company objectives and regulatory requirements.Provide expert advice on regulatory pathways, including IND, BLA, and CTA submissions.Ensure timely preparation and submission of regulatory documents to Health Authorities (FDA, EMA, ICH, etc.).Coordinate with internal departments (clinical, CMC, quality, manufacturing) to support regulatory submissions and compliance.Manage the preparation, compilation, and submission of regulatory dossiers, including INDs, BLAs, MAA, and global submissions.Stay up-to-date with evolving regulatory requirements for biologics in key markets (US, EU, Japan, etc.).Ensure product compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other applicable regulations.Qualifications:Bachelor's degree in Life Sciences, Pharmacy, or related field (Master's or PhD preferred).Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry, with a focus on biologics.Proven track record of managing regulatory submissions for biologics products, including INDs, BLAs, and international filings.Strong understanding of the biologics development process and global regulatory requirements (FDA, EMA, ICH, etc.).Experience with both preclinical and clinical regulatory activities, including CMC, clinical trial applications, and post-market submissions.Excellent project management skills, with the ability to manage multiple projects simultaneously.Proficient in regulatory submission management tools and project management software.Experience with biologic product lifecycle management, including commercialization.

Created: 2025-02-23