Manager / Deputy Manager Regulatory Affairs

As a Manager / Deputy Manager Regulatory Affairs in Vadodara, your role will involve developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. You will interact with regulatory agencies, manage timelines, and ensure that all products meet regulatory standards. - Develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects - Lead the preparation, review, and approval of submission documents for US FDA, EMA, Health Canada, Australia, and ANVISA - Provide strategic guidance on the impact of CMC changes on regulatory submissions and develop appropriate regulatory pathways - Review and evaluate CMC documents, including specifications, batch records, stability data, and change controls Collaboration with cross-functional teams to ensure regulatory compliance and timely submission will be essential. You will also participate in client discussions, training, and development activities as needed. Experience in handling teams and a total experience of 12 to 15 years is required for this role. Qualifications for this position include: - Experience in regulatory strategy development and implementation - Proficiency in preparing and submitting regulatory documents - Strong understanding of regulatory compliance - Excellent organizational and timeline management skills - Strong written and verbal communication skills - Ability to interact effectively with regulatory agencies - Experience in the pharmaceutical industry is a plus - Bachelor's degree in Pharmacy, Chemistry, or a related field is required,