Regulatory Affairs Specialist

|| Urgent Hiring || Regulatory Affairs Specialist || Mumbai Location ||

Designation : Regulatory Affairs Specialist

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 : 5 lpa

Location : Sandhurst Road Mumbai - Head office

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 good knowledge of Regulatory Submissions
• Must have good knowledge of Regulatory Research
• Must be familiar with chemical industry-specific regulations and guidelines.