Position: Regulatory Affairs Manager

Job type: Full Time, Permanent

Experience: 3 years

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Job content

Job Description:

  • Pharmacovigilance of small molecule products.
    • Preparation and submission of PSUR & RMP to DCGI office in stipulated time.
    • Maintaining Calendar of PSUR & keeping track of upcoming PSURs.
    • Preparation and submission of replies related to PSUR queries to DCGI Office.
  • Apprise the regulatory team on regulatory updates (New Guidelines/Gazettes/SEC MoMs/Notices/New approvals/CT NOC etc) laid down by CDSCO from implication point of view.
  • Providing regulatory status (e.g. worldwide approval status, CTRI status, available strengths and dosage forms, new indications, combination categorization etc.) and literature related to new/existing products as per the requirement.
  • Support in dossier preparation and submission for various types of DCG(I) applications for:
    • Manufacturing and Marketing applications for API & finished formulation.
    • Clinical Trial NOC.
    • Bioequivalence study NOC.
    • Query response in stipulated timelines.
  • Assisting in preparation for SEC presentation i.e., executive summary, presentation slides, literature set to support presentation.
  • Review International dossier related documents.

Desired Qualification/Skillset/Experience:

  • Pharmacy Postgraduate (M. Pharm)/Medical Graduate with minimum 3 Years experience.
  • Sound knowledge of Pharmacovigilance and Regulatory Affairs as per the prevailing guidelines.
  • Quick learner & Excellent team worker with strong organizational, cross-functional working, written and communication skills.
  • Self-motivated, hard-working and goal-oriented, ability to function in time-bound manner with high degree of flexibility, creativity, resourcefulness, commitment and optimism.

Competencies:

Intas - Action Oriented
Intas - Customer Focus
Intas - Dealing with Ambiguity
Intas - Problem Solving
Intas - Time Management

Job Location & Department:

Department : Medical Affairs.

Job Location : Ahmedabad, Gujarat, India.

Note: Intas does not charge any fee for job application, processing, training or testing. Do not participate in any such invitations.

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