Apply for Parexel Regulatory Affairs Consultant CMC Biologics remote role in India. Check eligibility, experience, responsibilities and apply online today.
Introduction
Experienced regulatory professionals looking to advance their careers in biologics and global submissions now have an excellent opportunity. A leading global CRO is hiring skilled candidates who can manage lifecycle activities, regulatory strategies, and CMC documentation for international markets. This role offers the flexibility of remote work along with exposure to diverse global regulatory frameworks.
Company Overview
Parexel is a leading Contract Research Organization (CRO) known for delivering clinical development, regulatory consulting, and market access solutions to pharmaceutical and biotechnology companies worldwide. With a strong focus on innovation and patient outcomes, Parexel supports clients in bringing safe and effective therapies to market efficiently.
Job Overview (Quick Details)
| Job Title | Regulatory Affairs Consultant – CMC Biologics |
|---|---|
| Company | Parexel |
| Location | India (Remote) |
| Employment Type | Full-Time / Consultant Role |
| Department | Regulatory Affairs – CMC |
| Experience Required | 7–10 Years |
| Education | Bachelor’s Degree (Advanced Degree Preferred) |
| Salary | As per company norms |
Job Location & Employment Type
- Location: Remote (Work from anywhere in India)
- Employment Type: Full-time / Consulting role
Open Position / Department Details
- Department: Regulatory Affairs (CMC Biologics)
- Focus Area: Lifecycle management, global regulatory submissions, and CMC documentation
- Work involves collaboration with international regulatory teams and clients
Key Roles & Responsibilities
Regulatory Strategy & Submissions
- Develop and execute regulatory strategies for biologics and vaccine products
- Plan, prepare, and deliver regulatory submissions for global markets
- Handle lifecycle management (LCM) activities for approved products
- Support submissions including IND, IMPD, DMF, BLA, NDA, and MAA
CMC Documentation & Compliance
- Author and review CMC sections of regulatory dossiers
- Prepare documentation for marketing authorization and post-approval variations
- Handle annual reports, renewals, and expansion submissions
- Evaluate change controls and deviations to determine regulatory impact
Global Regulatory Expertise
- Work with regulatory frameworks across US, EU, Japan, Canada, Switzerland, and Australia
- Stay updated with evolving regulatory guidelines and implement changes
- Support EU procedures such as DCP, MRP, and National Procedures
Health Authority Interaction
- Respond to queries from regulatory agencies
- Prepare scientifically accurate responses for compliance
- Ensure timely and high-quality submissions
Stakeholder Coordination
- Collaborate with internal teams and external clients
- Identify documentation gaps and ensure timely resolution
- Maintain high-quality standards for submission documents
Systems & Process Management
- Use Regulatory Information Management Systems (RIMS) such as Veeva Vault
- Maintain documentation accuracy and compliance records
- Ensure proper tracking of submissions and updates
Eligibility Criteria
Education
- Bachelor’s Degree in a Scientific or Technical discipline
- Advanced Degree (MSc, M.Pharm, PhD) preferred
Experience
- 7 to 10 years of experience in regulatory affairs, especially in biologics
- Strong experience in lifecycle management of marketed products
- Exposure to global regulatory submissions and procedures
Skills Required
- Strong knowledge of global regulatory frameworks
- Expertise in CMC documentation and biologics regulations
- Excellent communication and stakeholder management skills
- Ability to work independently and manage multiple projects
- Strong analytical and problem-solving capabilities
- Experience with RIMS tools like Veeva Vault
- Leadership and mentoring abilities
- High attention to detail and quality compliance
Salary & Benefits
- Salary: As per company norms
- Additional benefits may include:
- Remote working flexibility
- Global exposure in regulatory consulting
- Opportunity to work on biologics and advanced therapies
- Career growth and mentorship opportunities
Selection Process
The selection process may include:
- Application screening
- HR discussion
- Technical / regulatory interview
- Final round with leadership or client team
How to Apply
- Candidates should apply through the official Parexel careers portal
- Search for the role: Regulatory Affairs Consultant – CMC Biologics
- Submit an updated resume highlighting regulatory experience
Important Dates
- Last Date to Apply: Not specified (apply early)
Why Apply for This Pharma Job?
- Work with a globally recognized CRO in regulatory consulting
- Gain hands-on experience in international regulatory submissions
- Opportunity to specialize in biologics and advanced therapies
- Flexible remote work environment
- Exposure to global clients and regulatory authorities
- Strong career growth in regulatory affairs and consulting
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not associated with Parexel or any recruiter. We do not charge any fees for job updates. Applicants are advised to verify details and apply through official company sources only.
Final Call-to-Action
Experienced regulatory professionals are encouraged to apply now and take the next step in their global regulatory career journey.
