Senior Associate / Assistant Manager – Regulatory Affairs (Biologicals & Vaccines) at DDReg Pharma, Gurgaon
DDReg Pharma jobs offer a rare chance for experienced professionals in regulatory affairs. The organization is seeking a Senior Associate / Assistant Manager for its Gurgaon office, offering an exciting opportunity for candidates with relevant experience in regulatory submissions and compliance.
About the Company
DDReg Pharma is a prominent player in the pharmaceutical sector, specializing in regulatory affairs related to biologicals and vaccines. The organization is dedicated to ensuring compliance with regulatory standards and facilitating the approval process for innovative therapies. With a focus on quality and efficiency, DDReg Pharma plays a crucial role in advancing healthcare solutions.
Job Details:
- Position: Senior Associate / Assistant Manager – Regulatory Affairs (Biologicals & Vaccines)
- Location: Gurgaon
- Experience: 3–6 years of relevant regulatory affairs experience
- Qualification: Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology or a related field
DDReg Pharma Jobs: Job Description
For DDReg Pharma jobs in this role, the Senior Associate / Assistant Manager will be responsible for preparing and submitting CTD/eCTD dossiers to CDSCO, managing clinical trial applications, licenses, marketing authorizations, variations, and renewals. The role also involves handling SUGAM submissions and regulatory queries while ensuring compliance with CDSCO, NDCTR, and biologics guidelines. Coordination with clients, internal teams, and regulators is essential for success in this position.
Key Responsibilities
- Prepare and submit CTD/eCTD dossiers to CDSCO
- Manage clinical trial applications, licenses, marketing authorizations, variations, and renewals
- Handle SUGAM submissions and regulatory queries
- Ensure compliance with CDSCO, NDCTR, and biologics guidelines
- Coordinate with clients, internal teams, and regulators
How to Apply for DDReg Pharma Jobs
Interested candidates can apply through the official DDReg Pharma job page: https://resource.ddregpharma.com/jobs/careers-regulatory-affairs-biologicals-vaccines/
Additional Information
This position is office-based and full-time, providing a great opportunity for professionals looking to advance their careers in regulatory affairs within the pharmaceutical industry.
Why Join DDReg Pharma
DDReg Pharma offers a dynamic environment where professionals can thrive and contribute to the advancement of healthcare solutions. With a commitment to excellence and innovation, the organization provides ample opportunities for growth and development in the regulatory affairs domain.
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DDReg Pharma jobs present an excellent opportunity for qualified candidates to step into a pivotal role in regulatory affairs. Interested individuals are encouraged to apply before the deadline to seize this opportunity.