Regulatory Affairs API

Ver: 106

Día de actualización: 06-05-2024

Ubicación: Thane Maharashtra Mumbai

Categoría: Otra

Industria: Pharmaceutical & Life Sciences

Posición: Other

Tipo de empleo: Full Time, Permanent

Experiencia: 10 - 15 years

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Contenido de trabajo

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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