Manager / Deputy Manager Regulatory Affairs BDR Pharmaceuticals

12.0 - 16.0 years

0 Lacs

vadodara, gujarat

On-site

This is a full-time on-site role for a Manager / Deputy Manager Regulatory Affairs located in Vadodara. As the Manager / Deputy Manager, your responsibilities will include developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. Your role will involve interacting with regulatory agencies, managing timelines, and ensuring that all products meet regulatory standards. Your key responsibilities will be to develop and direct global regulatory strategies for clinical, non-clinical, and CMC aspects. You will lead the preparation, review, and approval of submission documents for US FDA, EMA, Health Canada, Australia, and ANVISA. Providing strategic guidance on the impact of CMC changes on regulatory submissions and developing appropriate regulatory pathways will be crucial aspects of your role. Additionally, you will 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, a strong understanding of regulatory compliance, excellent organizational and timeline management skills, strong written and verbal communication skills, and the ability to interact effectively with regulatory agencies. Experience in the pharmaceutical industry is a plus, and a Bachelor's degree in Pharmacy, Chemistry, or a related field is required.,

Posted 2 weeks ago

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