Global CRO leader Parexel is inviting applications for the position of Regulatory Affairs Associate in India. This remote opportunity is ideal for pharmaceutical and life sciences professionals with experience in Regulatory Affairs-CMC, CTD guidelines, lifecycle management, and regulatory submissions across global markets.
Candidates with 2-4 years of experience in regulatory affairs and a strong understanding of global regulatory frameworks can apply for this exciting role. The position requires collaboration with cross-functional teams and support for regulatory activities across the EU, US, LATAM, Brazil, and China markets.
Job Overview
| Details | Information |
|---|---|
| Position | Regulatory Affairs Associate |
| Company | Parexel |
| Experience | 2-4 Years |
| Job Type | Full-Time, Permanent |
| Work Mode | Remote |
| Hiring Location | Bengaluru, Karnataka, India |
| Department | Legal & Regulatory |
| Industry | Pharmaceutical & Life Sciences |
Key Responsibilities
As a Regulatory Affairs Associate at Parexel, you will:
- Understand and interpret global regulatory frameworks for pharmaceutical products.
- Support preparation and submission of Annual Reports and Renewals for various regulatory agencies.
- Assist in regulatory activities across the US, EU, Brazil, LATAM, China, and other international markets.
- Collaborate with cross-functional teams including CMC, Quality, Clinical, and Regulatory departments.
- Evaluate regulatory changes according to country-specific guidelines.
- Support lifecycle management activities for approved pharmaceutical products.
- Ensure compliance with CTD (Common Technical Document) guidelines and regulatory requirements.
- Contribute to regulatory documentation and submission strategies.
Required Qualifications
Educational Qualification
- Bachelor’s Degree in Pharmacy, Life Sciences, Biotechnology, Pharmaceutical Sciences, or related disciplines.
- Any Graduate with relevant Regulatory Affairs experience may also apply.
Experience
- 2 to 4 years of experience in Regulatory Affairs-CMC.
- Experience in annual report submissions and renewals.
- Exposure to global regulatory markets is preferred.
Required Skills
- Regulatory Affairs CMC
- CTD Guidelines
- eCTD Submissions
- Regulatory Compliance
- Change Evaluation
- Drug Regulatory Affairs
- Lifecycle Management
- Pharmaceutical Regulations
- Clinical Research
- Pharmacovigilance Knowledge
- ICH Guidelines
- USFDA Regulations
- EU Regulatory Affairs
- Regulatory Documentation
Preferred Qualifications
Candidates having experience in the following areas will have an added advantage:
- EU lifecycle management activities
- Annual Reports and Renewals for US and EU markets
- LATAM regulatory submissions
- Brazil and China regulatory requirements
- Cross-functional stakeholder management
Why Join Parexel?
Parexel is one of the world’s leading Contract Research Organizations (CROs), supporting pharmaceutical and biotechnology companies in bringing innovative therapies to patients.
Benefits of Working at Parexel
- Remote working flexibility
- Global regulatory exposure
- Career growth opportunities
- International project experience
- Collaborative work culture
- Exposure to multiple regulatory agencies
- Opportunity to contribute to global healthcare advancements
How to Apply
