Apply for Regulatory Affairs Consultant CMC Biologics job at Parexel remote India. Check eligibility, responsibilities, salary, and global regulatory career opportunities.
Introduction
The Regulatory Affairs Consultant CMC Biologics Job at Parexel is a senior-level opportunity for experienced professionals in regulatory affairs and biologics development. This role focuses on lifecycle management, regulatory strategy, and global submissions for complex biologic products. If you have extensive experience in CMC and international regulatory frameworks, this position offers a strong platform to work on high-impact global projects while enjoying remote flexibility.
Job Overview
| Job Details | Information |
|---|---|
| Job Title | Regulatory Affairs Consultant – CMC Biologics |
| Company Name | Parexel |
| Location | India (Remote) |
| Employment Type | Full-Time |
| Department | Regulatory Consulting |
| Experience Required | 7–10 Years |
| Education | Bachelor’s Degree (Advanced Degree Preferred) |
| Salary | As per company norms |
Company Overview
Parexel is a leading global Clinical Research Organization (CRO) that provides services in clinical development, regulatory consulting, and market access. The company collaborates with pharmaceutical and biotechnology organizations to accelerate the development of innovative therapies. Parexel is known for its strong global presence, high-quality standards, and commitment to improving patient outcomes.
Job Location & Employment Type
- Location: India (Work From Home)
- Employment Type: Full-Time
- Work Mode: Remote with international team collaboration
Open Positions / Department Details
This role is part of the Regulatory Consulting division, focusing on CMC Biologics. The position involves working with global clients on regulatory strategies, submissions, and lifecycle management for biologics and vaccines across multiple markets.
Key Roles & Responsibilities
The Regulatory Affairs Consultant CMC Biologics Job at Parexel includes high-level regulatory and strategic responsibilities:
Regulatory Strategy & Submissions
- Lead and contribute to global and regional regulatory submission strategies
- Plan, prepare, and deliver maintenance submissions for biologics
- Develop regulatory approaches for complex submissions
Lifecycle Management (LCM)
- Manage lifecycle activities for approved biologic products
- Handle variations, renewals, site transfers, and product expansions
- Support post-approval regulatory requirements across regions
CMC Documentation & Compliance
- Author and review CMC sections for submissions like IND, IMPD, BLA, NDA, DMF, and MAA
- Conduct regulatory gap analysis and prepare remediation plans
- Evaluate change controls and deviations for regulatory impact
Global Regulatory Expertise
- Ensure compliance with regulations across US, EU, Japan, Canada, Switzerland, and Australia
- Apply knowledge of regional regulatory frameworks and evolving guidelines
- Support submissions through procedures such as DCP, MRP, and national routes
Health Authority & Stakeholder Interaction
- Respond to health authority queries related to CMC
- Coordinate with internal teams and external stakeholders
- Identify and resolve quality or documentation issues proactively
Systems & Process Management
- Utilize Regulatory Information Management Systems (RIMS) like Veeva Vault
- Maintain accurate submission records and timelines
- Stay updated with regulatory changes and industry trends
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- Advanced degree (M.Sc, M.Pharm, PhD) preferred
Experience
- 7–10 years of experience in regulatory affairs
- Strong experience in biologics, vaccines, and CMC documentation
- Experience in global submissions and lifecycle management
Skills Required
- In-depth knowledge of global regulatory frameworks (US, EU, Japan, Canada, etc.)
- Expertise in CMC and biologics regulatory requirements
- Strong leadership and mentoring capabilities
- Excellent communication and stakeholder management skills
- Ability to work independently in a remote environment
- Strong analytical and problem-solving skills
- Familiarity with Veeva Vault or similar RIMS tools
- Strategic thinking and regulatory planning expertise
Salary & Benefits
- Salary: As per company norms
- Additional benefits may include:
- Remote work flexibility
- Health and wellness programs
- Performance-based incentives
- Learning and leadership development opportunities
- Exposure to global regulatory consulting projects
- Career growth in senior regulatory roles
Selection Process
The hiring process typically includes:
- Resume screening
- HR interview
- Technical/functional interview
- Final discussion with senior leadership
How to Apply
Interested candidates can apply for the Regulatory Affairs Consultant CMC Biologics Job at Parexel through the official online application portal. Ensure your resume highlights your experience in biologics, CMC, and global regulatory submissions.
Important Dates
- Application Deadline: Apply as soon as possible
Why Apply for This Job?
Here’s why this opportunity stands out:
- Work on high-impact biologics and vaccine projects
- Gain exposure to global regulatory frameworks and markets
- Collaborate with international clients and experts
- Strong career progression in regulatory consulting
- Opportunity to lead strategic regulatory initiatives
- Flexible remote working environment
This role is ideal for experienced professionals aiming to take leadership roles in regulatory affairs and biologics development.
FAQs
1. What is the role of a Regulatory Affairs Consultant CMC Biologics?
The role involves managing regulatory strategies, submissions, and lifecycle activities for biologic products.
2. What experience is required for this job?
Candidates need 7–10 years of regulatory affairs experience, especially in biologics and CMC.
3. Is this a remote job?
Yes, this is a work-from-home opportunity based in India.
4. What skills are essential for this role?
Key skills include regulatory strategy, CMC expertise, leadership, and global submission experience.
5. How can I apply for this job?
You can apply through Parexel’s official online application portal.
Conclusion
The Regulatory Affairs Consultant CMC Biologics Job at Parexel 2026 is a premium opportunity for senior professionals in regulatory affairs. With global exposure, leadership responsibilities, and cutting-edge biologics projects, this role offers significant career growth. Apply now to advance your journey in regulatory consulting.
Disclaimer
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