Regulatory Affairs API

Vue: 106

Jour de mise à jour: 06-05-2024

Localisation: Thane Maharashtra Mumbai

Catégorie: Autre

Industrie: Pharmaceutical & Life Sciences

Niveau: Other

Type d’emploi: Full Time, Permanent

Expérience: 10 - 15 years

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le contenu du travail

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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