Navitas Lifesciences Hiring Junior Regulatory Associate in Chennai

Navitas Lifesciences Hiring Junior Regulatory Associate | Regulatory Submissions Role in Chennai

Navitas Lifesciences, a leading global clinical research organization, is looking for a Junior Regulatory Associate to join their growing team in Chennai, India. This is an exciting opportunity for individuals who are passionate about regulatory affairs and have experience in regulatory submissions for pharmaceutical products.

As a Junior Regulatory Associate, you will play a key role in supporting the Publishing and Submissions team, contributing to regulatory filings, ensuring compliance with international regulatory standards, and assisting with document publishing for various agencies such as the US-FDA, EMA, and Health Canada.

Position Overview: Junior Regulatory Associate

Location:

Chennai, India

Qualification:

• Bachelor’s Degree in Pharma or a related field.

Experience:

• Prior experience in regulatory submissions (e.g., IND, ANDA, NDA, DMF) in CTD/eCTD formats for international regulatory agencies.
• Familiarity with regulatory document publishing, including bookmarking, hypertext linking, and preparing Tables of Contents.

Job Type:

• Full-time, Junior-level position

Key Responsibilities

As a Junior Regulatory Associate at Navitas Lifesciences, your primary responsibilities will include:

• Assisting in document-level publishing tasks, including hypertext linking, bookmarking, and preparing Tables of Contents as per regulatory guidelines.
• Supporting Regulatory Associates and Senior Regulatory Associates with submission publishing, archiving, and handling complex submissions.
• Ensuring compliance with customer SOPs and policies, as well as following Navitas Lifesciences’ internal procedures and regulatory standards.
• Supporting the preparation and publishing of regulatory documents for submissions such as INDs, ANDAs, NDAs, and DMFs in CTD/eCTD formats.
• Assisting with the review and dispatch of same-day submissions to ensure timely and accurate filing with regulatory agencies.

This position offers an excellent opportunity for growth in regulatory affairs, providing exposure to a wide variety of regulatory submissions and international regulations.

Desirable Skills and Experience

To be successful in this role, you should have:

• Hands-on experience with regulatory publishing and submissions, specifically for pharmaceutical products.
• Knowledge of regulatory requirements for IND, ANDA, NDA, and DMF submissions.
• Proficiency in preparing documents in CTD/eCTD formats for global regulatory authorities, including the US-FDA, EMA, and Health Canada.
• Strong attention to detail, ensuring that regulatory submissions are compliant with both internal and external policies.
• Excellent organizational skills, ensuring timely submission and dispatch of documents.

Location: Chennai, India

How to Apply

Interested candidates who meet the qualifications can apply for the Junior Regulatory Associate role by visiting the official Navitas Lifesciences careers page or directly via the following link:

• Apply here: Navitas Lifesciences Careers – Junior Regulatory Associate