1. Trainee Regulatory Associate

Location: Chennai
Job Type: Full-Time
Entry Level

Responsibilities:

• Manage end-to-end publishing support for IND/NDA/MAA applications and life cycle maintenance globally.
• Collaborate with various departments for submissions planning, preparation, and quality control.
• Support development of submission-ready documents for electronic submissions, including formatting and hyperlinking.
• Maintain knowledge of agency standards for regulatory submissions.
• Troubleshoot document issues and manage technical aspects of submissions.
• Perform quality checks on published outputs and ensure regulatory compliance.
• Provide training to colleagues and support data management tasks.

Desirable Skills:

• Proficient in MS Word, MS Excel, MS Access, MS PowerPoint, and Adobe Professional.
• Bachelor’s degree in Pharmacy/Pharmaceutical Chemistry or related life sciences.

2. Junior MICC Associate

Location: Bangalore, India
Job Type: Full-Time
Associate Level

Responsibilities:

• Follow global and local regulations for personal and client data protection.
• Handle calls and emails for case intake and ensure timely response and follow-up.
• Data entry of individual case safety reports into the safety database.
• Review and evaluate AE case information to determine required actions.
• Ensure the quality and accuracy of data entered and prepare source documents.

Desirable Skills:

• 1-3 years of experience in an MICC role.
• Graduate or postgraduate degree in life sciences.
• Strong communication skills for effective client communication.

3. Bioanalytical Scientist

Location: Manipal

We are currently seeking a dedicated Bioanalytical Scientist to join our dynamic team. The successful candidate will play a crucial role in developing and validating bioanalytical methods and ensuring the quality and efficiency of our laboratory operations.

Key Responsibilities:

• Develop and validate bioanalytical methods using LCMS and other sophisticated analytical instruments.
• Perform routine calibration and maintenance of laboratory instruments.
• Demonstrate thorough knowledge of LCMS, HPLC, HPTLC, GCMS, and other analytical instruments.
• Ensure compliance with USFDA guidelines in all laboratory processes.
• Collaborate effectively with team members to coordinate efforts and improve productivity.
• Exhibit strong interpersonal and management skills to facilitate teamwork and communication.
• Accountable for group productivity, focusing on the number of samples analyzed, quality, and turnaround time (TAT) improvements.

Desirable Skills and Experience:

• 2-5 years of experience in bioanalytics.
• Strong foundational knowledge of analytical instruments such as HPLC and LC-MS.
• Excellent communication skills, both verbal and written.

Submit Your Resume By Mentioning Role Name in Subject : recruitment.india@navitaslifesciences.com