Navitas is looking for a Regulatory Associate – Trainee in Chennai.

Job Description

Are you passionate about regulatory affairs and looking to kickstart your career? We are seeking a dedicated Regulatory Associate Trainee to join our team. This is an exciting opportunity to work with industry experts and contribute to high-impact regulatory submissions.

Key Responsibilities- Regulatory Associate – Trainee

As a Regulatory Associate Trainee, you will:

• Master Regulatory Requirements: Gain in-depth understanding of regulatory submission requirements, including IND, ANDA, NDA, and DMF in CTD/eCTD formats for agencies like the US-FDA, EMA, and Health Canada.
• Assist in Document Publishing: Support Regulatory Associates and Senior Regulatory Associates with document-level publishing. This includes bookmarking, hypertext linking, and preparing Tables of Contents as per guidelines.
• Submission Publishing Support: Provide comprehensive support for submission publishing, including archiving and reviewing same-day dispatches and major/complex submissions.
• Adherence to SOPs: Ensure compliance with customer SOPs and policies, along with adherence to the organization’s internal procedures.

Qualifications

• Educational Background: A Bachelor’s Degree in Pharmacy is required.
• Experience: Experience in publishing and submissions within a regulatory context is highly desirable.
• Location: Chennai, India.
• Employment Type: Full-time, Junior Level.

Desirable Skills and Experience

• Attention to Detail: Strong attention to detail and accuracy in document preparation and review.
• Technical Proficiency: Familiarity with CTD/eCTD formats and the technical aspects of regulatory submissions.
• Communication Skills: Excellent written and verbal communication skills.
• Team Player: Ability to work collaboratively in a team environment.
• Problem-Solving Skills: Strong analytical and problem-solving skills.

Why Join Us?

Joining our team means becoming part of an organization that values innovation, collaboration, and professional growth.

About Navitas

Pioneers Since 1994

Since our inception in 1994, Navitas has been at the forefront of educational innovation. We pioneered a unique university partnership model and have continued to shape the educational landscape globally. From our humble beginnings in Perth, Western Australia, we have grown into one of the world’s leading education organizations.

Leader in Global Education

Navitas is dedicated to providing life-changing learning opportunities for students at 98 campuses across the globe. Our commitment to excellence ensures that students receive top-tier teaching and learning support, tailored to harness their talents and enhance their well-being.

Our Commitment to You

• Professional Growth: We offer opportunities for continuous learning and professional development.
• Supportive Environment: Join a supportive team that values your contributions and fosters a collaborative working atmosphere.
• Global Opportunities: With our global presence, there are opportunities to work on diverse projects and collaborate with international teams.

How to Apply

If you are enthusiastic about regulatory affairs and meet the qualifications outlined above, we encourage you to apply. Join us and be part of a team that is making a difference in the world of education and beyond.

Additional Information

• Company Culture: At Navitas, we foster a culture of innovation, inclusion, and continuous improvement. Our team members are encouraged to think creatively and contribute to the development of new strategies and solutions.
• Employee Benefits: We offer a comprehensive benefits package, including health insurance, retirement plans, and opportunities for professional development and career advancement.
• Community Engagement: Navitas is committed to giving back to the communities we serve. We actively participate in various social responsibility initiatives and encourage our employees to get involved.

Ready to Take the Next Step?

If you are ready to embark on a rewarding career journey with Navitas, apply now! We look forward to welcoming you to our team and supporting your growth as a Regulatory Associate Trainee.

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Disclaimer: We strongly advise against paying any third-party individuals or agencies who claim to offer job placements at our company. All job openings are filled based on merit through our official hiring channels. Protect yourself from fraud and ensure that your application is processed securely and fairly by only engaging directly with our official representatives.