Job Opportunity in Product Development(Solid Orals)

7 - 12 years

7 - 12 Lacs

Posted:3 days ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

Role & responsibilities

  1. Plan, execute, control and carry out projects with outsource CDO/CMO/CDMO partners to support the process of approval and launching new products in Canada and export market.
  2. Organise cross functional activities, ensuring completion of the project while adhering to regulatory and quality requirements specific to Canada and export countries.
  3. Co-ordination with clinical team to understand BE requirement and logistic team to arrange reference samples to partners.
  4. Tracking the project status and update the project tracker on regular basis.
  5. Need sound knowledge on F&D and basic analytical concepts understanding
  6. Literature search: DPD database, Patent database, NOC database, Pharmacopeias and related ICH and regulatory guidelines
  7. Primary review of draft manufacturing documents like MFR, BMR, Spec and stability protocols in accordance with development data and regulatory requirements.

Preferred candidate profile

Detailed knowledge of Formulation Development

Experience with Modified Release dosage forms

Handled Queries for Regulatory market ( Canada/US/EU)

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