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

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 career@acmeformulation.com or WhatsApp on 9418155173