Are you a recent graduate eager to kickstart your career in the biotechnology and pharmaceutical industry? Immuneel Therapeutics Pvt. Ltd., a leader in cell and gene therapy, is thrilled to announce a new opportunity for the role of Regulatory Affairs Trainee. This entry-level position offers hands-on experience in the dynamic and rapidly growing field of regulatory affairs, particularly in cell and gene therapy.

About Immuneel Therapeutics

Immuneel Therapeutics is dedicated to transforming cancer treatment through innovative therapies such as CAR-T cell therapy. As part of our mission to advance healthcare, we are looking for passionate individuals to join our Regulatory Affairs team and help navigate the complex regulatory landscape of cutting-edge therapies.

Key Responsibilities of the Regulatory Affairs Trainee

As a Regulatory Affairs Trainee, you will play an important role in supporting our regulatory team by:

• Assisting in Regulatory Submissions: Preparing essential documentation for regulatory submissions related to cell and gene therapy products, including CAR-T therapies.
• Regulatory Mapping: Identifying and mapping out key regulatory requirements and guidelines for the approval and commercialization of CAR-T products.
• Cross-functional Collaboration: Working closely with different departments across the company to ensure that regulatory requirements are integrated into product development stages.
• Supporting Product Approval Submissions: Contributing to the submission process for product approvals and ensuring compliance with various regulatory bodies.

Qualifications for the Regulatory Affairs Trainee Role

To be eligible for this exciting opportunity, candidates must have:

• Educational Background:
  • M.Pharm in Regulatory Affairs
  • M.Sc./M.Tech in Biotechnology, Biopharmaceutical Technology, Biological Sciences, or a relevant field
  • Regulatory certification in the regulatory affairs of biotech or biopharmaceutical products is highly desirable.

This position is ideal for recent graduates or individuals with minimal experience looking to gain practical knowledge in the regulatory affairs of cell and gene therapies.

Essential Skills for Success

• Understanding of Regulatory Processes: Familiarity with regulatory guidelines and requirements, especially in the context of biotech and biopharmaceutical products, is crucial.
• Detail-oriented: You should have a keen eye for detail when preparing documentation and ensuring regulatory compliance.
• Strong Communication Skills: The ability to communicate effectively with cross-functional teams and regulatory bodies.
• Teamwork: You will work alongside various teams, so collaboration is key.

How to Apply for the Regulatory Affairs Trainee Position

If you’re ready to take the first step in your regulatory affairs career with a focus on groundbreaking therapies, this is the perfect opportunity! Here’s how you can apply:

• Step 1: Prepare your resume, highlighting your educational qualifications and any relevant certifications.
• Step 2: Email your resume to careers@immuneel.com with the subject line: “Resume for Regulatory Affairs Trainee”.
• Step 3: Only shortlisted candidates will be contacted for further interviews.