Regulatory Affairs API

View: 106

Update day: 06-05-2024

Location: Thane Maharashtra Mumbai

Category: Other

Industry: Pharmaceutical & Life Sciences

Position: Other

Job type: Full Time, Permanent

Experience: 10 - 15 years

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Job content

Expertise in Control strategy and DMF preparations
Thorough understanding the deficiencies received and to prepare appropriate response to avoid repeat deficiency.
Provide responses to regulatory agencies regarding product information or issues.
Train staff in regulatory policies or procedures.
Coordinate internal discoveries and depositions with legal department staff.
Develop and maintain standard operating procedures or local working practices.
Establish regulatory priorities or budgets and allocate resources and workloads.
Maintain current knowledge of relevant regulations, including proposed and final rules.
Manage activities such as audits, regulatory agency inspections, or product recalls.
Obtaining marketing permission for a new product
Outlining requirements for a products labeling, packaging, and storage
Writing concise, clear, and informative product information leaflets
Overseeing the completion of all regulatory compliance documents.

Preferred from western line of Mumbai .

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