Trainee Regulatory Associate job vacancies in Bangalore

Are you a detail-oriented individual with a passion for ensuring the accuracy and timeliness of regulatory submissions in the pharmaceutical industry? PharmaReg Research welcomes you to explore the role of Regulatory Associate within our dynamic team based in Chennai, India. As a Regulatory Associate, you will play a crucial role in facilitating the submission of regulatory documents to health authorities, contributing to the advancement of pharmaceutical regulation.

Position Title: Regulatory Associate
Company Name: Navitas lifesciences pvt ltd
Salary: Competitive, commensurate with experience
Location: Chennai, India

Detailed Job Description

Role:
PharmaReg Research is seeking a dedicated and detail-oriented Regulatory Associate to join our team. As a Regulatory Associate, you will play a key role in ensuring the accurate and timely submission of regulatory documents to various health authorities.

Industry Type: Pharmaceutical

Department: Regulatory Affairs

Employment Type: Full-time

Role Category: Junior

Education:

• UG: Bachelor’s degree in Pharmacy or related field

Key Skills:
Regulatory Associate – Join Our Pharmaceutical Regulatory Team

Responsibilities:

• Gain a comprehensive understanding of regulatory requirements for submissions such as IND, ANDA, NDA, and DMF in CTD/eCTD formats.
• Collaborate with Regulatory Associates and Senior Regulatory Associates to assist in document-level publishing tasks, including bookmarking, hypertext linking, and Table of Contents preparation according to guidelines.
• Provide essential support in submission publishing, ensuring compliance with archiving, same-day dispatch, and major/complex submissions.
• Adhere to customer-specific SOPs and Policies, while upholding PharmaReg Research’s internal policies and procedures.

Desirable Skills and Experience:

• Previous experience in publishing and regulatory submissions is required.
• Strong attention to detail and organizational skills are essential.
• Familiarity with regulatory guidelines from health authorities such as US-FDA, EMA, and Health Canada is advantageous.

Apply online