doublehrconsultancy@gmail.com |
Mumbai
Job Location: Sandhurst Road, -Head Office, Mumbai
• Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or chemistry
• Experience : Minimum 4 to 6 years of experience in regulatory affairs
• Salary : Good Hike on Current CTC
• 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,
Experience | 4 - 6 Years |
Salary | 4 Lac To 6 Lac P.A. |
Industry | Health Care / Pharmaceuticals / Medical |
Qualification | B.Pharma, B.Sc, M.Pharma, M.Sc |
Key Skills | Regulatory Affairs API Chemical Company |
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