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Regulatory Affairs API
Visualizza: 106
Giorno di aggiornamento: 06-05-2024
Località: Thane Maharashtra Mumbai
Categoria: Altra
Industria: Pharmaceutical & Life Sciences
Posizione: Other
Tipo di lavoro: Full Time, Permanent
Esperienza: 10 - 15 years
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Contenuto del lavoro
- 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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Scadenza: 20-06-2024
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