Regulatory Services Life Sciences Specialist

1 day ago


Bengaluru, Karnataka, India Lifelancer Full time

Company Overview

Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.

About the Job

We are seeking a skilled Regulatory Services Life Sciences Specialist to join our team. The successful candidate will be responsible for performing regulatory operations tasks, including bookmarking and hyper linking for granular components of submission in accordance with ICH guidelines and other Health Authorities. The role requires strong analytical skills, attention to detail and ability to work well in a team.

Salary

The estimated annual salary for this position is $85,000 - $115,000, depending on experience and qualifications.

Job Description

In this role, you will be aligned with our Life Sciences RD vertical, working across the entire life sciences enterprise from research laboratories, clinical trials support, and regulatory services, to pharmacovigilance and patient services solutions. Your primary responsibilities will include:

  • Performing Quality Control (Document QC) checks for all submission components.
  • Coordinating essential documentation and resources required for the filing of global applications.
  • Understanding and managing process electronic submissions that include original application filings, Life Cycle Management submissions such as CMC, Ad-promos, amendments, annual reports, SPL submissions, etc.

Required Skills and Qualifications

To be successful in this role, you will need:

  • A Bachelor of Pharmacy/Master of Pharmacy degree.
  • 3 to 5 years of experience in regulatory services or a related field.
  • Strong analytical skills and attention to detail.
  • Ability to work well in a team and meet deadlines.

Benefits

We offer a dynamic and supportive work environment, competitive salary and benefits package, and opportunities for professional growth and development.



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