Regulatory Affairs Specialist

11 hours ago

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

Job Description Designation : Regulatory Affairs Specialist Qualifications: Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry Experience : Minimum 4 years of experience in regulatory affairs Salary : good hike on current salary 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 understanding of Regulatory Research - Must be familiar with chemical industry-specific regulations and guidelines.

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