Job Description: 

1. Understanding and knowledge of regulatory guidance for new dossier submission and post-approval variation on key emerging markets like Brazil & rest Latam countries, South Africa, Russia, and ASEAN region
2. Planning and preparation of registration dossier in conventional/country-specific format and CTD/eCTD/ACTD.
3. Coordination with different stakeholders of various departments i.e. FDD, ADD, CAL, packaging, PMO, plant, and overseas regulatory counterpart.
4. Good understanding and potential on life cycle management activities i.e. renewal dossiers and post-approval variation.
5. Handling and preparation of draft response against queries raised by regulatory agencies within the stipulated timeline.
6. Candidate should have good communication and interpersonal skills.
7. Good understanding of analytical validation including a resolution on analytical issues should be preferred.

Qualification: B.Pharma/M.Pharma

Experience: 6-9 Years

Salary: Negotiable

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