Parexel Hiring Remote Senior Regulatory Affairs Associate
- Senior Regulatory Affairs Associate – Remote (India)
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility / Qualifications
- Educational Qualifications
- Experience & Skills
- Location & Salary
- Application Process
- Frequently Asked Questions (FAQs)
- Is this a fully remote role?
- Which regulatory markets will I work on?
- What product types are covered in this role?
- Summary Table
Senior Regulatory Affairs Associate – Remote (India)
Parexel hiring Senior Regulatory Affairs Associate in India (Remote). Global regulatory submissions for US, EU, Japan & more.
Parexel is hiring a Senior Regulatory Affairs Associate to join its global consulting team in a remote role based in India. This opportunity is ideal for regulatory professionals who want to work on high-impact global submissions while enjoying the flexibility of remote work.
In this role, you will support leading biopharmaceutical and medical device companies by shaping regulatory strategies and delivering high-quality submissions across major regulated markets. The position offers exposure to complex product portfolios, diverse therapeutic areas, and mentorship from experienced regulatory leaders.
Company Overview
Parexel is a globally recognized clinical research and regulatory consulting organization supporting the development and commercialization of innovative medical therapies. Through Parexel Consulting, the company partners with biopharmaceutical, biotechnology, and medical device organizations to navigate evolving global regulatory landscapes.
Known for its scientific depth and regulatory expertise, Parexel plays a critical role in accelerating patient access to safe and effective therapies. The company promotes a culture of collaboration, continuous learning, and flexibility, making it a preferred workplace for regulatory professionals worldwide.
Job Role & Responsibilities
As a Senior Regulatory Affairs Associate, you will contribute to global and regional regulatory activities across multiple regulated markets.
Key Responsibilities
- Manage new registrations, renewals, and lifecycle management activities.
- Support regulatory submissions for biologicals, vaccines, recombinant proteins, monoclonal antibodies, plasma-derived products, and small molecules.
- Prepare, author, and review regulatory dossiers from a global and regional perspective.
- Contribute to Marketing Authorization Applications (MAA) and variations for submission in US, EU, Japan, Canada, Switzerland, and Australia.
- Apply in-depth understanding of global regulatory frameworks and regional regulatory trends.
- Support CMC-related regulatory documentation in alignment with ICH guidelines.
- Collaborate closely with cross-functional teams and global stakeholders.
- Work independently while managing multiple regulatory projects and timelines.
Eligibility / Qualifications
Educational Qualifications
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or a related scientific discipline
Relevant Courses (comma-separated):
B.Pharm, M.Pharm, Pharmaceutics, Biotechnology, Regulatory Affairs, Pharmaceutical Sciences, Life Sciences
Experience & Skills
- Strong experience in global regulatory affairs within pharmaceutical or biotechnology environments
- Proven exposure to regulated markets including US, EU, Japan, Canada, Switzerland, and Australia
- Sound knowledge of global pharmaceutical legislation and regulatory guidance
- Strong understanding of regulatory CMC requirements for small and large molecules
- Excellent written and verbal communication skills
- Ability to collaborate effectively and work independently in a remote environment
Location & Salary
Job Location: India (Remote)
Employment Type: Full Time
Salary: Competitive and aligned with industry standards based on experience and expertise
Application Process
Interested candidates can apply directly through the official Parexel careers portal:
Apply here:
https://jobs.parexel.com/en/job/-/-/877/90333192256
Frequently Asked Questions (FAQs)
Is this a fully remote role?
Yes. This position is remote within India.
Which regulatory markets will I work on?
You will support submissions for US, EU, Japan, Canada, Switzerland, and Australia.
What product types are covered in this role?
Biologicals, vaccines, recombinant proteins, monoclonal antibodies, plasma-derived products, and small molecules.
Summary Table
| Company | Parexel |
|---|---|
| Vacancies | Senior Regulatory Affairs Associate |
| Required Education | Bachelor’s/Master’s in Pharmacy or Life Sciences |
| Experience | Senior Level – Global Regulatory Affairs |
To apply for this job please visit jobs.parexel.com.
