job location: lower parel mumbai
• qualifications : bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry
• experience : minimum 4 to 6 years of experience in regulatory affairs
• salary : good hike on current ctc
• essential duties and responsibilities:
regulatory compliance: ensure company products comply with relevant regulatory requirements, such as usfda, fda, ema, and local regulations.
submission management: prepare and submit regulatory documents, such as inds, ndas, and maas, to regulatory agencies.
regulatory strategy: develop and implement regulatory strategies to support product development and commercialization.
regulatory intelligence: stay up-to-date with changing regulatory requirements and provide guidance to internal stakeholders.
audits and inspections: coordinate and manage regulatory audits and inspections.
labeling and advertising: review and approve product labeling and advertising materials for regulatory compliance.
regulatory agency interactions: communicate with regulatory agencies, such as the fda, to address questions and concerns.
regulatory documentation: maintain and manage regulatory documents, such as regulatory submissions,