Work From Home Jobs Syneos Health Hiring Senior Regulatory Associate with EU market experience for remote and hybrid regulatory affairs roles in India.
Company Overview
Syneos Health® is a globally established biopharmaceutical services organization delivering integrated solutions across clinical development, regulatory affairs, medical affairs, and commercialization. With a strong international presence spanning more than 100 countries, the company partners with leading pharmaceutical and biotech organizations to support product development, approvals, and lifecycle management across global markets.
Syneos Health is known for its patient-focused approach, regulatory excellence, and collaborative work culture. Professionals working here gain exposure to complex global regulatory projects, diverse therapeutic areas, and evolving international health authority requirements. Syneos Health Hiring Senior Regulatory Associate
Job Location & Employment Type
- Primary Work Mode: Remote (Pre-Approved)
- Alternate Location: Gurugram, India (Hybrid)
- Employment Type: Full-Time
- Industry: Regulatory Affairs, Clinical Research, Biopharmaceutical Services
Open Positions / Department Details
- Job Title: Senior Regulatory Associate (EU Market Experience)
- Department: Regulatory Affairs
- Job Requisition ID: 25105062
- Career Level: Senior Associate
This position is intended for regulatory professionals with hands-on experience supporting European and international regulatory submissions.
Key Roles & Responsibilities
The Senior Regulatory Associate will support global regulatory submissions and lifecycle activities while ensuring compliance with applicable regional regulations. Responsibilities include: Syneos Health Hiring Senior Regulatory Associate
- Preparing and submitting regulatory applications and components for initial marketing authorization and post-approval variations
- Supporting EU regulatory submissions, along with exposure to APAC and Gulf markets
- Assisting in the preparation and review of regulatory dossiers in compliance with regional health authority requirements
- Supporting authoring and compilation of CTD Modules 2 and 3
- Managing regulatory lifecycle maintenance activities, including renewals and variations
- Processing regulatory documentation with high accuracy under defined timelines
- Maintaining regulatory records, trackers, and submission logs in internal or client databases
- Performing quality control checks on regulatory documents prior to submission
- Coordinating with project managers, senior regulatory colleagues, and cross-functional teams
- Participating in client meetings and contributing to regulatory strategy discussions
- Tracking submission timelines and identifying potential risks to project delivery
- Escalating issues proactively and supporting resolution strategies
- Reviewing work completed by junior team members for quality and consistency
- Assisting in onboarding, training, and mentoring regulatory associates as required
- Ensuring completion of all mandatory internal and client-specific training
Eligibility Criteria
Education
- Bachelor’s degree (BS/BA) in Pharmacy, Life Sciences, or a related discipline
- Equivalent practical regulatory experience may also be considered
Experience
- Minimum 2–3 years of regulatory affairs experience
- Mandatory experience supporting EU market submissions
- Exposure to APAC and Gulf regulatory markets is desirable
- Experience in post-approval variations and marketing authorization applications is required
Skills Required
- Strong understanding of EU regulatory requirements and submission processes
- Hands-on experience with CTD structure, especially Modules 2 and 3
- Excellent documentation and quality control skills
- Strong analytical and problem-solving abilities
- Proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to manage multiple regulatory projects simultaneously
- Excellent written and verbal communication skills in English
- Ability to work independently in a remote or hybrid environment
- Strong interpersonal skills for cross-functional and client interactions
Syneos Health Hiring Senior Regulatory Associate
Salary & Benefits
- Salary: As per company norms
- Competitive compensation based on experience and responsibilities
- Career development and progression opportunities
- Access to regulatory, technical, and therapeutic training programs
- Employee recognition initiatives and total rewards programs
- Flexible working arrangements including remote and hybrid options
Syneos Health Hiring Senior Regulatory Associate
Selection Process
- Application screening
- Technical and regulatory interview
- Project or competency-based discussion
- HR interview and final selection
The selection process may vary depending on project needs.
How to Apply
Interested candidates should apply through the official Syneos Health careers portal using Job Requisition ID: 25105062.
- Application Mode: Online
- Work Model: Remote / Hybrid (subject to approval)
Early applications are encouraged as positions may close without notice.
Important Dates
- Job Posted On: Today
- Last Date to Apply: Not Mentioned
Why Apply for This Pharma Job?
This role offers a valuable opportunity to work on global regulatory submissions with a company that supports the majority of recently approved FDA and EMA products. Candidates gain hands-on exposure to EU regulatory frameworks, lifecycle management activities, and cross-regional regulatory strategies. Flexible work options and structured career growth make this an ideal role for experienced regulatory professionals seeking long-term advancement. Syneos Health Hiring Senior Regulatory Associate
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent pharmaceutical job information platform and is not affiliated with Syneos Health® or its recruitment process. All job information is shared for informational purposes only. Candidates are advised to verify details directly through the official company website before applying. Syneos Health Hiring Senior Regulatory Associate
Final Call-to-Action
If you have experience in EU regulatory submissions and are looking for a global regulatory career with flexible working options, apply today and take the next step in regulatory affairs. Syneos Health Hiring Senior Regulatory Associate
