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Walk-in Interview for Regulatory Affairs Officer / Executive Post at Rusan Pharma-13th March 2025
Zusammenfassung
A leading pharmaceutical company in Mumbai is seeking an Officer/Executive for its Regulatory Affairs team focusing on APIs. The role involves preparing regulatory submissions, collaborating with teams, and ensuring compliance with international standards. Ideal candidates will have 2-5 years of experience and an M.Sc. in Chemistry or Pharmaceutical Sciences. Join us for a walk-in interview on March 13, 2025.
Qualifikationen
- 2 to 5 years of experience in regulatory affairs.
- Strong understanding of API regulatory requirements.
- Familiarity with international regulatory standards.
Aufgaben
- Review and compile dossiers for API regulatory submissions.
- Prepare and submit Drug Master Files (DMFs) according to regulations.
- Collaborate with teams to gather necessary data for submissions.
- Manage regulatory queries and responses from health authorities.
- Ensure compliance with ICH, USFDA, EDQM standards.
- Maintain regulatory documentation and update records.
Kenntnisse
Ausbildung
Rusan Pharma Ltd., a research-driven pharmaceutical company, is seeking dynamic professionals for its Regulatory Affairs – API team. With a strong presence in India and international markets, Rusan specializes in Pharmaceutical Formulations, Active Pharmaceutical Ingredients (APIs), and Intermediates. Our state-of-the-art facilities are approved by Health Canada, EUGMP, and EDQM.
Department: Regulatory Affairs – API
Experience: 2 to 5 years
Qualification: M.Sc. (Chemistry / Pharmaceutical Sciences)
- Review and compile dossiers for API regulatory submissions.
- Prepare and submit Drug Master Files (DMFs) in compliance with regulatory requirements.
- Collaborate with cross-functional teams to gather data for dossier preparation.
- Handle regulatory queries and coordinate responses from global health authorities.
- Ensure adherence to ICH guidelines, USFDA, EDQM, and other international regulatory standards.
- Maintain regulatory documentation and update databases.
Date: 13th March 2025
Time: 9:00 AM – 5:00 PM
Venue: Rusan Pharma Ltd, 58D Industrial Estate, Charkop, Kandivali West
Join us and be a part of our innovative and fast-growing team!
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