Regulatory Affairs Trainee

Quality HR Services

0 - 1 years

1 - 2 Lacs

raigarh khopoli

Posted:15 hours ago| Platform:

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Skills Required

dossier gmp ich qc quality assurance ectd pharmaceutical usfda quality control production anda regulatory documentation data integrity ent production department ra ctd regulatory affairs cmc manufacturing drug regulatory affairs dmf actd

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Assist in the
preparation and compilation
of regulatory dossiers (CTD / ACTD / eCTD) for product registration in various markets.
Support the collection and review of technical documents from
R&D, QA, QC, and Production
departments.
Help maintain
regulatory databases, tracking sheets
, and product registration status logs.
Learn and follow current
regulatory guidelines (USFDA, WHO, MHRA, EU, CDSCO)
.
Assist in the
submission of post-approval changes
, annual updates, and renewal applications.
Draft and format
regulatory documents, letters, and summaries
.
Help respond to regulatory agency
queries and deficiencies
under guidance.
Ensure
compliance with documentation practices
, data integrity, and version control systems.

Required Skills

Basic knowledge of GMP, ICH, and regulatory guidelines
Understanding of dossier structure (Modules 15) is a plus
Good written and verbal communication skills
Attention to detail and strong organizational skills
Ability to work in a team and meet deadlines
Proficiency in MS Office (Word, Excel, Outlook)

Required Qualification:- B.Pharm/M.Pharm.

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