Regulatory Affairs Executive

☞ Zieva Farm Pvt Lt

View: 106

Update day: 28-05-2024

Location: Mumbai Maharashtra

Category: Pharmacist / Pharmaceutical representatives

Industry:

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Job content

JH of Pharmacist:

  • Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
  • Provide expert regulatory input to strategic decision making; including portfolio review, prioritization, and external communications, Product packaging, Artwork etc.
  • Provide expert regulatory input to in-licensing evaluations and due diligence activities
  • Provide advice about regulations to manufacturers/scientists
  • Coordinate successful submissions and approval of all applications /Dossiers
  • Ensure that quality standards are met and that the deliverables meet strict deadlines and fulfil standards
  • Plan, undertake and oversee product Dossier, Samples, PIL etc and regulatory inspections if require.
  • Keep up-to-date with changes in regulatory legislation and guidelines
  • Write comprehensible, user-friendly, clear product information leaflets and labels,
  • Liaise and negotiate with regulatory authorities, Regulatory departments of Pharma companies, Overseas Co-ordination with Pharmacist for Product release and address the quarries.
  • B. Pharm or M. Pharm with at least 2-3 Years of Experience working in reputed Pharma Company for CIS region is preferable.
  • Deep experience from pharmaceutical industry from a regulatory affairs perspective (Knowledge in OSD & Injectable will be an added advantage)
  • Knowledge of ICH Guideline, CTD Dossier, Compliance of quarry submission, relevant guidelines, procedures and requirements
  • Fluent in oral and written English
  • IT skills

Job Types: Full-time, Regular / Permanent

Salary: ₹20,000.00 - ₹30,000.00 per year

Schedule:

  • Morning shift

Education:

  • Master’s (Preferred)

Experience:

  • total work: 7 years (Preferred)

Language:

  • English (Preferred)
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Deadline: 12-07-2024

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