Regulatory Affairs Specialist

Airvin Skills

0 years

0 Lacs

bengaluru vellore delhi / ncr

Posted:2 hours ago| Platform:

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Skills Required

pharmacovigilance regulatory affairs clinical research clinical data management regulatory compliance drug regulatory affairs team coordination medical devices clinical trials computer skills ich communication skills medical writing drug safety medical affairs

Work Mode

Hybrid

Job Type

Full Time

Job Description

Regulatory Affairs Specialist (Fresher)

recent graduates

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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