Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 1K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

RATE NOW!
- ABECA 2025
  
  RATE NOW!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

Add office photos

Employer? Claim Account for FREE

Samarth LifeSciences

Compare

3.5

based on 214 Reviews

1 Samarth LifeSciences Executive Regulatory Affairs Job

Executive - Regulatory Affairs

Samarth Life Science

3.5

based on 214 Reviews

3-4 years

₹ 3.5 - 3.2L/yr (AmbitionBox estimate)

Mumbai

1 vacancy

Executive - Regulatory Affairs

Samarth LifeSciences

posted 30d ago

Job Role Insights

Flexible timing

Key skills for the job

Legal Biochemistry Auditing Life Sciences Database Management Process Validation

Job Description

1. Preparation and submission of dossiers as per countries assigned.

2. Review of Process Validation, Product development records, BMR,BPR,Stability data, Certificate of Analysis etcrequired for dossiers.

3. FDA related work- Application of COPP, Legalization of Documents through different embassies, Loan License documentation etc

4. Co-ordinate with departments such as Manufacturing,Product Development,QA/QC,RD, Legal,Purchase etc to ensure availability of documents and samples for submission.

5. To check review Art-works, Labels, and Pack-inserts.

6. Response of queries and other requirements as required by respective regulatory authorities in a stipulated time frame.

Key Accountabilities :

1. Keeping abreast of international legislations, guidelines and customer practices in all countries that the company is exporting to.

2. Keeping up-to-date with changes in regulatory environment in the home country and countries of operation.

3. Maintaining Country-wise database of registration status and updating Marketing team periodically.

Education , Experience Knowledge requirement :

Education : B.Pharm/M.Pharm

BSc / MSc (Life-sciences/Chemistry)

Experience : 3-4 years experience in preparation of dossiers and successful registrations in ROW Countries especially SEA and Africa.QA/QC/RD experience and having participated in Audits will be an added advantage

Knowledge requirement (Mandatory) : Knowledge of CTD ACTD dossier preparation for the South East Asia,Latin America, Africa Middle East countries

Employment Type: Full Time, Permanent

Read full job description

Prepare for Executive Regulatory Affairs roles with real interview advice