Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry
Experience : Minimum 10 years of experience in regulatory affairs
Budget upto 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 valuable knowledge of Regulatory Submissions
- Must have good knowledge of Regulatory Research
- Must be familiar with chemical industry-specific regulations and guidelines.