Looking for a Regulatory Affairs job in the pharmaceutical industry? Syneos Health is inviting applications for the position of Regulatory Associate. This is an excellent remote Regulatory Affairs opportunity for professionals with 2โ3 years of experience in EU regulatory submissions, post-approval variations, and marketing authorization applications.
Candidates with hands-on experience in EU Regulatory Affairs, eCTD, CTD documentation, Module 2 & Module 3 authoring, health authority queries, and ICH guidelines are encouraged to apply.
If you’re aiming to build your career in Global Regulatory Affairs, this could be the right opportunity.
Job Details
| Particular | Details |
|---|---|
| Company | Syneos Health |
| Position | Regulatory Associate |
| Job Type | Full-Time |
| Location | Remote |
| Experience | Minimum 2โ3 Years |
| Department | Regulatory Affairs |
Key Responsibilities
As a Regulatory Associate, you will:
- Prepare and manage regulatory submissions for EU, APAC, and Gulf markets.
- Support Initial Marketing Authorization Applications (MAA).
- Handle Post-Approval Variations and lifecycle management activities.
- Author, review, and compile Module 2 and Module 3 documents.
- Prepare and maintain CTD/eCTD submissions.
- Respond to Health Authority Queries within timelines.
- Ensure compliance with ICH Guidelines, regulatory standards, and internal SOPs.
- Review regulatory documentation for quality, completeness, and accuracy.
- Collaborate with cross-functional global teams for submission readiness.
Required Qualifications
Candidates should possess:
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.
- 2โ3 years of Regulatory Affairs experience, preferably in EU markets.
- Strong understanding of:
- EU Regulatory Affairs
- Marketing Authorization Applications (MAA)
- Post Approval Variations
- CTD & eCTD formatting
- Module 2 & Module 3 authoring
- Health Authority responses
- ICH Guidelines
- Excellent documentation and communication skills.
Preferred Skills
- Experience with EU, APAC, or Gulf regulatory markets.
- Regulatory authoring and document review expertise.
- Good knowledge of global pharmaceutical regulations.
- Ability to work independently in a remote environment.
- Strong attention to detail and regulatory compliance.
Why Join Syneos Health?
- Remote work opportunity
- Exposure to global regulatory submissions
- Opportunity to work on international pharmaceutical projects
- Collaborative global work environment
- Career growth in Regulatory Affairs
- Learn and work with experienced regulatory professionals
How to Apply
Interested candidates can send their updated resume to:
Email: anamika.jayprakash@syneoshealth.com
Subject Line: Application for Regulatory Associate โ Remote
Apply as early as possible since positions may close once suitable candidates are shortlisted.