Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry
Experience : Minimum 4 years of experience in regulatory affairs
Salary : valuable hike on current salary
Location : Lower Parel, Mumbai
Job Summary:
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.
Training and Guidance: Provide regulatory training and guidance to internal stakeholders.
Compliance Monitoring: Monitor company activities for compliance with regulatory requirements.
Skills:
Must have valuable knowledge of Regulatory Submissions
Must have good understanding of Regulatory Research
Must be familiar with chemical industry-specific regulations and guidelines.
Pay: ₹500,000.00 - ₹700,000.00 per year
Perks:
Provident Fund
Application Question(s):
How many Years of experience in Regulatory Strategy?
What is your current ctc?
what is your expected ctc?
Have yuo qualified Bachelor's d