Regulatory Affairs Executive

24 hours ago


Borivali Mumbai Maharashtra, India TheTalentforte.com Full time

Manufacturer of Pharmaceutical Tablets, Oral Suspension & Pharmaceutical Medicines. A dynamic Pharmaceutical company of approximately turnover of US $ 200 million and operating business in more than 50 countries.

**REGULATORY AFFAIRS EXECUTIVE**
**Job Location: BORIVILI**

**QUALIFICATION**
BPharma / MPharma **OR** MSc + Diploma in Drug Regulatory Affairs

**EXPERIENCE**
4 to 5 years in Regulatory Affairs of Pharma Formulations

**JOB PROFILE**
Filing ACTD dossier in ROW/African and Indian Market.
Knowledge of ICH quality guidelines and maintain regular updates.
Application of COPP for exporting country.
Arrangement of Product Samples as per country guidelines/client requirements.
To arrange administrative documents required for dossier submission & export purpose.
Review and maintain regulatory documentation in databases or systems
To Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission.
Handling queries pertaining to regulatory submissions from various regulatory authorities.
Maintain record of Samples, Shade Cards and Registration Certificate etc.
Preparation of Package Inserts, Product characteristics and Patient information leaflet.
To check & approve the artworks for regulated / semi regulated countries

**COMPETENCIES REQUIRED**
Good technical knowledge, review skills and understanding of regulatory submissions
Strong knowledge of CTD /eCTD requirements for submission of dossiers
Good analytical and problem-solving skills.
Ability to try new approaches when faced with challenges.
Should have a good analytical and learning attitude.
Proactive to submission of response to any queries.
Excellent communication skills

**If you find this opportunity interesting, Please send us the following**:
Your updated CV
Current or last CTC:
Your Residence location:
Joining Period if you are selected

Regards,

Pooja Nair
TheTalentorte.Com
Pharmaceuticals & Chemicals Recruiter

Schedule:

- Day shift



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