Regulatory Affairs Manager (EU/US)

As a Regulatory Affairs Manager, you will play a crucial role in monitoring the company's production activities to ensure compliance with all applicable regulations and standard operating procedures. Your responsibilities will include devising regulation compliance strategies, creating training and orientation programs for staff, conducting internal inspections and information drives, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of Chemistry, Manufacturing, and Controls (CMC) aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents according to regulatory guidelines, evaluate changes in CMC documentation impacting regulatory submissions, strategize filing categories, and compile submissions for Europe, FDA, and other international markets. - Conduct Due Diligence and develop CMC strategy for complex injectable products, with a strong background in CMC requirements for EU/US solid dosage forms and/or complex injectables, particularly in Ophthalmic products. - Collaborate with internal and external stakeholders to compile high-quality regulatory submissions within specified timelines, ensuring accuracy, compliance, and quality of submission documents. - Evaluate change controls independently in alignment with regulatory requirements, strategize filing categories, compile submissions, and resolve complex issues for EU and international markets. - Demonstrate strong interpersonal skills for effective verbal and written communication in a collaborative work environment. Extensive experience with ANDA/EU DCP/ IMPD/IND writing is expected. Qualifications Required: - MPharm/PhD/MSc in Chemistry or Biotechnology - 4-8 years of prior experience in regulatory affairs Please note that the given Job Description did not include any additional details about the company.,