Drug Regulatory Affairs Officer

Laborate Pharmaceuticals

4 - 6 years

3 - 6 Lacs

panipat

Posted:6 hours ago| Platform:

Apply

Skills Required

drug regulatory affairs dra regulatory affairs dossier preparation row market

Work Mode

Work from Office

Job Type

Full Time

Job Description

Preparation & Compilation of Dossier in ACTD / CTD format as per standard guidelines of the countries
Handling of Daily activities of D.R.A. department
Review of Technical documents and samples for registration purpose.
Preparation of documents as per specific requirement of the countries.
Knowledge of legal documents and Authority's Regulatory documents such as NOC, Product Permission, COPP, FSC, Manufacturing licenses, GMP, WHO GMP etc.
Responsible for Preparation / Reviewing of :- (i) MSDS (ii) Package Insert/PIL (iii) Drug Master File (IV) RMP
Product Artwork checking & approval in regulatory aspects for export and maintain their records.
Ability to work productively in a team environment with good interpersonal skills.
Co-ordination for Technical documents and sample requirements for submission with internal departments like QC, QA, Production, Analytical Development, Micro, F & D, R&D.
Update licensing and collect information on registration instructions and regulation.
Evaluation of Bioequivalence and Clinical Trials (preferably).
Having knowledge of ICH guideline
To be flexible for travelling and meeting with manufacturing plant representatives, which located out station.
Must have excellent communication skills
Must have excellent in analyzing skills
Excellent in accuracy and focus
Self-motivated and enthusiastic
Knowledge of Ms Office (Word, Excel, PowerPoint, Internet Applications, Email etc.)
Job Location will be

PANIPAT

only (Candidate apply only if comfortable for Panipat Location)

More Jobs at Laborate Pharmaceuticals

Mis Executive

Panipat

1.0 - 5.0 yrs

INR 2 - 4 Lacs

Drug Regulatory Affairs Officer

panipat

4.0 - 6.0 yrs

INR 3 - 6 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.