Regulatory Affairs Associate job at Syneos Health Mumbai. Check eligibility, responsibilities, skills, and apply online for pharma regulatory role today now.
Introduction
If you are aiming to build a career in regulatory affairs and drug development, this opportunity can be a strong step forward. The Regulatory Affairs Associate Job at Syneos Health offers hands-on experience in regulatory submissions, dossier management, and global compliance processes.
This role is ideal for candidates interested in pharmaceutical regulations, documentation, and working within a global clinical and regulatory environment.
Job Overview
| Details | Information |
|---|---|
| Job Title | Regulatory Affairs Associate |
| Company Name | Syneos Health |
| Location | Mumbai, India |
| Employment Type | Full-time (Hybrid) |
| Department | Regulatory Affairs / Clinical Solutions |
| Experience Required | As per role requirements (Entry–Mid level) |
| Education | Life Sciences / Pharmacy / Related Fields |
| Salary | As per company standards |
Company Overview
Syneos Health is a leading global organization providing integrated clinical, commercial, and consulting services to pharmaceutical and biotechnology companies. The company plays a key role in accelerating drug development and helping organizations navigate regulatory complexities.
With a strong global presence and involvement in a large percentage of FDA and EMA-approved products, Syneos Health offers excellent exposure to international regulatory standards and clinical processes.
Job Location & Employment Type
- Location: Mumbai, India
- Work Mode: Hybrid (combination of office and remote work)
- Employment Type: Full-time
Open Positions / Department Details
- Role: Regulatory Affairs Associate
- Department: Clinical Solutions / Regulatory Affairs
- Focus on regulatory submissions, documentation, and compliance for pharmaceutical products.
Key Roles & Responsibilities
As a Regulatory Affairs Associate, your responsibilities will include:
Regulatory Submissions & Documentation
- Assisting in preparation and management of drug registration files
- Supporting renewals, variations, and import license documentation
- Preparing documents for regulatory submissions and tenders
Data Management & Systems
- Managing internal databases for dossiers and artwork tracking
- Updating regulatory tools and documentation systems
- Performing bibliographic and literature searches when required
Coordination & Strategy Support
- Supporting planning and strategy for drug registrations
- Coordinating with internal teams and external stakeholders
- Ensuring timely document readiness for submissions
Administrative & Operational Support
- Preparing administrative documents (emails, translations, legalizations)
- Maintaining records, archives, and contact databases
- Organizing meetings and supporting departmental operations
Eligibility Criteria
Education
Candidates must have a degree in:
- Pharmacy (B.Pharm / M.Pharm)
- Life Sciences
- Biotechnology or related fields
Experience
- Entry-level to mid-level candidates can apply
- Experience in regulatory affairs or clinical documentation is preferred
Skills Required
- Knowledge of regulatory processes and documentation
- Strong organizational and documentation skills
- Attention to detail and accuracy
- Good communication and coordination skills
- Ability to work with databases and regulatory tools
- Analytical thinking and problem-solving ability
Salary & Benefits
- Salary: As per company standards
- Hybrid working flexibility
- Exposure to global regulatory frameworks (FDA, EMA)
- Career growth in regulatory affairs and clinical research
- Training and development programs
- Inclusive and collaborative work culture
Selection Process
The selection process may include:
- Resume screening
- Technical/functional interview
- HR interview
- Final selection
How to Apply
- Candidates should apply through the official Syneos Health careers portal.
- Ensure your resume highlights relevant regulatory or clinical experience.
Important Dates
- Last date to apply: Not specified
Why Apply for This Job?
The Regulatory Affairs Associate Job at Syneos Health is a great opportunity for candidates who want to build a career in global regulatory affairs.
Here’s why this role stands out:
- Work with a globally recognized life sciences organization
- Exposure to international drug approval processes
- Hands-on experience in regulatory documentation and submissions
- Opportunity to collaborate with global teams
- Career growth in:
- Regulatory Affairs
- Clinical Research
- Drug Development
- Medical Affairs
FAQs
1. Who can apply for this job?
Candidates with Pharmacy or Life Sciences backgrounds can apply.
2. Is this a remote job?
No, it is a hybrid role based in Mumbai.
3. What is the salary offered?
Salary is provided as per company standards.
4. Is experience required?
Entry-level to mid-level candidates can apply, with preference for regulatory experience.
5. How can I apply?
You can apply through the official Syneos Health careers website.
Conclusion
The Regulatory Affairs Associate Job at Syneos Health provides a strong platform for candidates looking to enter or grow in the regulatory domain. With exposure to global compliance standards and drug development processes, this role offers excellent long-term career potential.
If you are interested in regulatory affairs and pharmaceutical documentation, this is a great opportunity—apply now.
Disclaimer
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