Cian Healthcare Limited, a WHO-GMP & ISO-certified pharmaceutical company, is hiring Regulatory Affairs Executives / Officers in Pune, Maharashtra. This is a fantastic opportunity for pharma professionals to contribute to global regulatory compliance and product registration in the nutraceutical, cosmetic, and pharmaceutical sectors. If you have hands-on experience in CTD/eCTD dossier preparation and a keen eye for regulatory details, this role is ideal for you.
Key Responsibilities
- Prepare, review, and compile CTD/eCTD dossiers for domestic and international product registration.
- Coordinate with R&D, QA, QC, Production, and Packaging teams for documentation and data collection.
- Develop Module 1–5 dossiers in accordance with country-specific regulatory guidelines.
- Handle regulatory submissions, renewals, and variations with global partners.
- Maintain and update product registration databases and submission trackers.
- Review product labeling, artwork, and promotional materials for regulatory compliance.
- Support responses to regulatory queries and deficiency letters.
- Stay updated with global regulatory guidelines (ICH, USFDA, EMA, MHRA, WHO, etc.).
Required Qualifications
- B.Pharm / M.Pharm / M.Sc. in Chemistry, Biotechnology, or related field.
- Minimum 1 year of experience in dossier preparation (CTD/eCTD format).
- Good understanding of international regulatory guidelines.
- Strong documentation, analytical, and communication skills.
- Proficiency in MS Office; knowledge of eCTD compilation software is a plus.
Benefits
- Competitive salary (INR 5–8 LPA).
- Exposure to international regulatory affairs and global compliance practices.
- Professional development in regulatory strategy and dossier management.
- Opportunity to work in a WHO-GMP & ISO-certified pharmaceutical environment.
Application Instructions
Interested candidates can apply directly by sending their updated resumes to:
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- Email: hrd@cian.co, ramanager@cian.co, suraj@cian.co
- Contact: Vaishali: +91 9850375339 | Suraj: +91 7620742114
Location: Pune, Maharashtra
Employment Type: Full-time | On-site
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