Senior Regulatory Specialist

1 day ago


Mumbai, Maharashtra, India OrbiTouch HR (orbiTouch outsourcing pvt ltd) Full time

Designation : Regulatory Affairs Specialist
Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry
Experience : Minimum 10 years of experience in regulatory affairs
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.


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