Job openings for regulatory affairs executive in mumbai

Regulatory Affairs- 4 To 6 Yrs Exp.(API Chemical Company)Sandhurst Road,Mum 21

Mumbai

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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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