Job openings for regulatory affairs specialist in mumbai harbour mumbai

Urgent Opening
Regulatory Affairs-Specialist
(API Chemical Company)
Job LocationL : Sandhurst Road, -Head Office, Mumbai
• Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry
• Experience : Minimum 2-5 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, approvals, and correspondence.