Apply for Parexel Senior Regulatory Affairs Associate remote job in India. Check eligibility, lifecycle management responsibilities, and apply online today.
Introduction
Regulatory professionals with experience in lifecycle management and global submissions can explore a rewarding opportunity with a leading CRO. This role focuses on managing regulatory documentation, post-approval changes, and compliance activities across markets. It is ideal for candidates looking to strengthen their expertise in regulatory affairs while working in a flexible remote setup.
Company Overview
Parexel is a globally recognized Contract Research Organization (CRO) that provides end-to-end clinical development, regulatory consulting, and market access services. The company collaborates with pharmaceutical and biotech organizations worldwide to accelerate drug development and ensure regulatory compliance across regions.
Job Overview (Quick Details)
| Job Title | Senior Regulatory Affairs Associate |
|---|---|
| Company | Parexel |
| Location | India (Remote) |
| Employment Type | Full-Time |
| Department | Regulatory Affairs |
| Experience Required | 5–8 Years |
| Education | Life Sciences / Pharmacy / Related Field |
| Salary | As per company norms |
Job Location & Employment Type
- Location: Remote (India)
- Employment Type: Full-time
Open Positions / Department Details
- Department: Regulatory Affairs
- Focus on lifecycle management, regulatory submissions, and compliance
- Involves collaboration with global and cross-functional teams
Key Roles & Responsibilities
Regulatory Documentation & Submissions
- Prepare, compile, and review country-specific regulatory documents (Module 1, administrative forms, templates)
- Support submissions for new registrations, renewals, and variations
- Handle safety updates including PSUR and PBRER submissions
- Manage labeling updates and CMC-related regulatory changes
- Ensure compliance with local health authority requirements
Lifecycle Management & Change Control
- Evaluate change control notifications related to manufacturing, quality, and safety
- Conduct regulatory impact assessments for country-specific changes
- Coordinate implementation of post-approval changes within timelines
- Prepare and submit variation dossiers as per regulatory classifications
- Track submission progress and ensure timely approvals
Regulatory Systems & Data Management
- Maintain regulatory databases such as Veeva RIMS
- Ensure accurate tracking of submissions and product registrations
- Manage documentation archives in compliance with regulations
- Ensure data integrity and proper record-keeping
Audit & Compliance Support
- Assist during internal audits and health authority inspections
- Prepare regulatory documents required for audits
- Support responses to audit observations and findings
- Coordinate CAPA (Corrective and Preventive Actions) activities
- Ensure ongoing compliance with changing regulatory guidelines
Cross-Functional Collaboration
- Work with teams including Quality, Supply Chain, Pharmacovigilance, Medical, and Commercial
- Coordinate with global regulatory teams for dossier alignment
- Communicate effectively with stakeholders to ensure smooth submissions
Eligibility Criteria
Education
- Bachelor’s degree in Life Sciences, Pharmacy, or related field
- Advanced degree (M.Pharm, MSc, etc.) is preferred
Experience
- 5 to 8 years of experience in regulatory affairs
- Strong experience in lifecycle management activities
- Experience with global regulatory submissions is preferred
Skills Required
- Strong knowledge of CTD/eCTD structure (especially Module 1)
- Experience in renewals, variations, PSUR/PBRER submissions
- Understanding of change control processes and regulatory impact
- Familiarity with regulatory databases like Veeva RIMS
- Excellent documentation and attention to detail
- Strong communication and stakeholder management skills
- Ability to work independently and in cross-functional teams
- Good organizational and planning skills
Salary & Benefits
- Salary: As per company norms
- Additional benefits may include:
- Remote working flexibility
- Exposure to global regulatory projects
- Career growth in regulatory affairs
- Learning and development opportunities
Selection Process
The hiring process may include:
- Application screening
- HR interview
- Technical/regulatory interview
- Final round
How to Apply
- Candidates should apply through the official Parexel careers portal
- Search for the role: Senior Regulatory Affairs Associate
- Submit an updated resume highlighting regulatory experience
Important Dates
- Last Date to Apply: Not specified
Why Apply for This Pharma Job?
- Opportunity to work with a globally reputed CRO
- Gain expertise in lifecycle management and regulatory submissions
- Exposure to international regulatory frameworks
- Flexible remote work environment
- Strong career growth in regulatory affairs domain
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform and is not affiliated with Parexel or any recruiter. We do not charge any fees for job postings. Candidates should verify all details from official sources before applying.
Final Call-to-Action
Interested and eligible candidates should apply as soon as possible to advance their career in regulatory affairs with a global organization.
