Regulatory Affairs Manager (EU/US)

Role Overview: As a Regulatory Affairs Manager, you will be responsible for monitoring the company's production activities to ensure compliance with applicable regulations and standard operating procedures. Your key responsibilities will include devising regulation compliance strategies, creating training programs for staff, conducting internal inspections, and staying updated with the latest rules and regulations. Key Responsibilities: - Possess in-depth technical knowledge of CMC aspects, dossier compilation, review, evaluation, and compilation for new marketing authorizations. - Review and approve submission documents in line with regulatory guidelines, evaluate changes in CMC documentation, strategize filing categories, and compile submissions for Europe, FDA, and other international markets. - Conduct due diligence and develop CMC strategy for complex injectable products. - Coordinate with internal and external stakeholders to compile high-quality regulatory submissions within stipulated timelines, ensuring accuracy, compliance, and quality. - Assess regulatory documents for compliance with requirements and strategize filing categories for submissions to EU and international markets. - Evaluate change controls, compile submissions, and resolve complex issues for EU and international markets. - Utilize strong interpersonal skills for effective communication in a collaborative work environment and demonstrate experience with ANDA/EU DCP/IMPD/IND writing. Qualifications Required: - MPharm/PhD/MSc in Chemistry/Biotechnology. - 4-8 years of prior experience in regulatory affairs. ,