Home
Jobs

Regulatory Affairs Officer

0 years

1 Lacs

Posted:2 days ago| Platform: SimplyHired logo

Apply

Work Mode

On-site

Job Type

Full Time

Job Description

  • Responsible to prepare and review of dossier as per CTD / ACTD / Country specific guidelines
  • Responsible for dossier compilation and query response
  • Co-ordination with Cross-Functional Team and Business Partners
  • To prepare and review all technical documents
  • Proficiency in literature search for products at various stage of R&D.
  • Ability to conduct secondary research and acquire information from internet sources, journals, public databases, etc.
  • Experienced and good hand-on drafting Clinical & non-clinical overview/summary.
  • Required knowledge of toxicity studies, BA-BE studies and clinical trials.
  • Working on regulatory agencies regarding
  • Pre-submission strategies, potential regulatory pathways.
  • Review of documents to ensure there are no gaps
  • Maintains the highest level of submission standards.
  • Maintains familiarity with evolving and/or new regulatory e-submission requirements maintains the highest level of submission standards.
  • Maintains familiarity with evolving and/or new regulatory e-submission requirements
  • Familiarization with evolving guidance of Row markets

Job Type: Full-time

Pay: ₹10,000.00 - ₹15,000.00 per month

Benefits:

  • Flexible schedule

Schedule:

  • Day shift

Supplemental Pay:

  • Yearly bonus

Work Location: In person

Mock Interview

Practice Video Interview with JobPe AI

Start Business Development Interview
cta

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.

Job Application AI Bot

Job Application AI Bot

Apply to 20+ Portals in one click

Download Now

Download the Mobile App

Instantly access job listings, apply easily, and track applications.

coding practice

Enhance Your Skills

Practice coding challenges to boost your skills

Start Practicing Now

RecommendedJobs for You

Mumbai, Mumbai Suburban, Mumbai (All Areas)