Apply for Senior Regulatory Affairs Associate Parexel 2026 remote job. Check eligibility, salary, experience, and application process for biotech professionals.
Looking to advance your career in regulatory affairs within the biopharma sector? The Senior Regulatory Affairs Associate – CMC Biologics role at Parexel offers an excellent opportunity for experienced professionals to work remotely while contributing to global regulatory strategies. This position is ideal for candidates with strong expertise in biologics, vaccines, and regulatory submissions across international markets.
Job Overview
| Field | Details |
|---|---|
| Job Title | Senior Regulatory Affairs Associate – CMC Biologics |
| Company Name | Parexel |
| Location | India (Remote) |
| Employment Type | Full-Time |
| Department | Regulatory Affairs / Consulting |
| Experience Required | 5 – 8 Years |
| Education | B.Pharm, M.Pharm, Pharm.D, MSc, Life Sciences |
| Salary | As per company norms |
Company Overview
Parexel is a globally recognized clinical research and consulting organization that supports pharmaceutical, biotechnology, and medical device companies. With a strong presence across multiple countries, Parexel focuses on improving global healthcare by accelerating drug development and ensuring regulatory compliance.
The company is known for its collaborative work culture, innovation-driven mindset, and commitment to employee growth through continuous learning and mentorship programs.
Job Location & Employment Type
This is a remote (work-from-home) opportunity based in India, offering flexibility while working with international clients and teams. It is a full-time position within the regulatory consulting division.
Open Positions / Department Details
The role is part of the Regulatory Affairs – CMC Biologics team, focusing on regulatory strategy and submission management for biologics and related products across global markets such as:
- United States (US)
- European Union (EU)
- Japan
- Canada
- Switzerland
- Australia
Key Roles & Responsibilities
As a Senior Regulatory Affairs Associate – Parexel, you will be responsible for managing regulatory processes and supporting global submissions. Key responsibilities include:
- Preparing and reviewing regulatory documents for global submissions
- Supporting Marketing Authorization Applications (MAA) and lifecycle management activities
- Handling regulatory filings for biologics, vaccines, and recombinant products
- Managing variations, renewals, and post-approval changes
- Collaborating with cross-functional teams and global stakeholders
- Ensuring compliance with international regulatory guidelines (ICH, FDA, EMA, etc.)
- Providing strategic regulatory input for product development and market entry
- Monitoring updates in regulatory policies and industry trends
- Maintaining high-quality documentation and submission standards
Eligibility Criteria
Education
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related fields
- Accepted qualifications: B.Pharm, M.Pharm, Pharm.D, MSc, or equivalent
Experience
- Minimum 5 to 8 years of experience in regulatory affairs
- Experience with biologics, vaccines, monoclonal antibodies, and recombinant proteins
- Exposure to global regulatory markets (US, EU, Japan, etc.)
Skills Required
- Strong knowledge of CMC regulatory requirements
- Excellent communication and coordination skills
- Ability to work independently in a remote setup
- Detail-oriented with strong analytical abilities
- Familiarity with global pharmaceutical regulations and guidelines
- Team collaboration and stakeholder management
Salary & Benefits
- Salary: As per company norms
- Work-from-home flexibility
- Exposure to international regulatory projects
- Continuous learning and skill development
- Career growth opportunities in global consulting
- Collaborative and inclusive work environment
Selection Process
The recruitment process typically includes:
- Online application submission
- Resume screening by HR
- Technical interview (Regulatory Affairs focus)
- Final HR discussion
How to Apply
Interested candidates can apply through the official company career portal by submitting their updated resume and required details.
Why Apply for This Job?
This role offers a unique opportunity to work with a globally respected organization while building expertise in regulatory affairs for biologics. Here’s why this job stands out:
- Work on global regulatory submissions across major markets
- Gain hands-on experience in CMC biologics regulatory strategy
- Enjoy the flexibility of a remote work environment
- Collaborate with experienced professionals and industry experts
- Enhance your profile in the high-demand regulatory consulting field
For professionals aiming to build a long-term career in regulatory affairs, this role provides strong exposure, learning, and growth potential.
FAQs
1. What is the required experience for this role?
Candidates must have 5 to 8 years of experience in regulatory affairs, especially in biologics and global submissions.
2. Is this a work-from-home job?
Yes, this is a fully remote position based in India.
3. What qualifications are required?
Applicants should have a degree in Pharmacy or Life Sciences such as B.Pharm, M.Pharm, Pharm.D, or MSc.
4. What kind of products will I work on?
You will work on biologics, vaccines, monoclonal antibodies, and recombinant proteins.
5. How can I apply for this job?
You can apply through the official Parexel careers website by submitting your application online.
Conclusion
The Senior Regulatory Affairs Associate – Parexel Jobs 2026 is an excellent opportunity for experienced regulatory professionals looking to expand their global exposure. With remote flexibility, strong career growth, and involvement in international regulatory projects, this role is ideal for candidates aiming to excel in the pharma consulting domain. Apply now to take your regulatory career to the next level.
Disclaimer
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