Regulatory Affairs Opportunities: Immacule Lifesciences Calling B. Pharm, M. Pharm

ACME LIFE TECH LLP Recruitment Notification
  • Full Time
  • Anywhere
  • ₹45000 INR / Month

Introduction: Embark on a transformative journey with Immacule Lifesciences, a trailblazer in the pharmaceutical industry. As we continue to grow, we are seeking talented individuals to join our Regulatory Affairs – Injectable team in Ahmedabad. Discover opportunities as an Executive or Assistant Manager and play a pivotal role in shaping the future of healthcare.

About Immacule Lifesciences: Immacule Lifesciences, a name synonymous with innovation and excellence in the pharmaceutical sector. Our journey is marked by a commitment to quality and a culture of continuous improvement. Founded with a vision to make a meaningful impact, we invite you to be part of our dynamic team.

Company Vacancies List:

  • Position Titles: Executive, Assistant Manager
  • Qualification: B. Pharm / M. Pharm
  • Experience: 4 to 10 Years
  • Location: Ahmedabad

Job Description: As an Executive/Assistant Manager in Regulatory Affairs – Injectable (US/Europe), your responsibilities will include:

  • Compilation of ANDAs and 505(b)(2) applications with USFDA.
  • Experience in submission of pre-ANDA meetings for complex products with USFDA.
  • Review of DMFs of complex peptide drug substances.
  • Ensure timely responses for ANDA deficiencies.
  • Labeling compilation, including SPL and side-by-side comparison against RLD labels.
  • Life cycle management of products, approval package compilation, and more.

How to Apply: Interested candidates can share their updated resumes at or WhatsApp on 9418155173

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