Manager / Deputy Manager – Regulatory Affairs

Location : Vadodara

Role Description

This is a full-time on-site role for a Manager / Deputy Manager – Regulatory Affairs located in Vadodara. The role includes developing and implementing regulatory strategies, ensuring compliance with regulatory requirements, preparing and submitting regulatory documents, and maintaining regulatory files. The Manager / Deputy Manager will interact with regulatory agencies, manage timelines, and ensure that all products meet regulatory standards.

Job Description :

• 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.
• Work closely with cross-functional teams to ensure regulatory compliance and timely submission.
• Participate in client discussions, training, and development activities as needed.
• Handling Team
• Experience : 12 to 15 Years

Qualifications

• 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