Regulatory Affairs Specialist
4 days ago
E
We are looking for a passionate and detail-oriented Regulatory Affairs Specialist (Fresher) to join our life sciences and healthcare compliance team.
The ideal candidate will be responsible for assisting in the preparation, review, and submission of regulatory documents and ensuring adherence to national and international standards for product approval and compliance.
This role offers a great opportunity for recent graduates in Pharmacy, Biotechnology, Life Sciences, or related fields to begin their career in the pharmaceutical and healthcare regulatory sector.
Key Responsibilities:
- Assist in preparing and submitting regulatory documents to health authorities.
- Maintain up-to-date knowledge of regulatory guidelines, policies, and procedures.
- Support document control and data management related to product registration and licensing.
- Coordinate with R&D, Quality Assurance, and Manufacturing teams for regulatory data collection.
- Review labeling, packaging, and promotional materials for compliance.
- Prepare technical summaries and regulatory dossiers as required.
Preferred Skills (Good to Have):
- Knowledge of ICH, WHO, CDSCO, USFDA, and EU regulatory guidelines.
- Familiarity with CTD/eCTD documentation format.
- Basic proficiency in MS Office (Word, Excel, PowerPoint).
- Understanding of Good Documentation Practice (GDP).
Eligibility Criteria:
- Bachelors/Masters degree in Pharmacy (B.Pharm/M.Pharm), Biotechnology, Microbiology, or Life Sciences.
- Strong attention to detail and documentation skills.
- Good understanding of drug development and approval processes (preferred).
- Excellent communication and coordination abilities.
- Eagerness to learn regulatory frameworks and compliance standards.
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