If you’re an experienced regulatory professional looking to work on global biologics projects, this opportunity at Parexel could be a strong career move. As a Senior Regulatory Affairs Associate (CMC Biologics), you will contribute to complex regulatory submissions across major global markets while working remotely from India. This role offers a blend of strategic responsibility, technical depth, and flexibility.
About the Role
Parexel is hiring for the position of Senior Regulatory Affairs Associate – CMC Biologics under its consulting division. In this role, you will support biopharmaceutical clients in navigating regulatory pathways and accelerating product approvals across global markets.
This is a remote opportunity based in India, allowing professionals to work with international teams while maintaining flexibility.
Key Responsibilities
- Handle regulatory submissions for biologics including vaccines, monoclonal antibodies, and recombinant proteins
- Manage lifecycle activities such as renewals and variations across global markets
- Prepare and review Marketing Authorization Applications (MAA)
- Contribute to global regulatory strategy development
- Ensure compliance with regulatory frameworks in US, EU, Japan, Canada, Switzerland, and Australia
- Collaborate with cross-functional teams and clients
- Support documentation aligned with ICH guidelines and CMC requirements
Required Qualifications
- 5 to 8 years of experience in Regulatory Affairs (Biologics/CMC)
- Strong knowledge of global regulatory frameworks and submission processes
- Experience handling biologics, vaccines, plasma-derived products, and small molecules
- Understanding of ICH guidelines and pharmaceutical legislation
- Excellent communication and collaboration skills
- Ability to work independently in a remote setup
Preferred Skills
- Detail-oriented and analytical mindset
- Strong problem-solving ability
- Strategic thinking and execution
- Relationship-building skills with stakeholders
- Results-driven approach
Salary & Benefits
- Estimated Salary: ₹12 LPA – ₹22 LPA (based on experience and expertise)
- Remote work flexibility
- Exposure to global regulatory projects
- Learning and development opportunities
- Mentorship from experienced professionals
- Collaborative and inclusive work culture