Senior Regulatory Associate Remote Jobs at Syneos Health for EU market experience with remote and hybrid options in India.
Company Overview
Syneos Health is a globally established biopharmaceutical solutions organization supporting pharmaceutical and biotechnology companies across clinical development, regulatory affairs, medical affairs, and commercial operations. With a strong international footprint and thousands of professionals working across multiple continents, the organization is recognized for its integrated service delivery model and high-quality regulatory expertise. Syneos Health partners with sponsors to support product development, regulatory submissions, and lifecycle management across major global markets, offering employees exposure to complex international regulatory environments and long-term career growth opportunities. Senior Regulatory Associate Remote Jobs
Job Location & Employment Type
- Work Locations:
- India – Remote (Pre-Approved)
- Gurugram, Haryana – Hybrid
- Employment Type: Full-Time
- Work Model: Remote / Hybrid (based on approval and business requirements)
Open Positions / Department Details
- Job Title: Senior Regulatory Associate – EU Market
- Department: Regulatory Affairs
- Job Requisition ID: 25105062
This role is designed for regulatory professionals with hands-on experience supporting European Union (EU) regulatory submissions and post-approval activities, including lifecycle maintenance and dossier management. Senior Regulatory Associate Remote Jobs
Key Roles & Responsibilities
The Senior Regulatory Associate will play a key role in supporting regulatory submission activities and ensuring compliance with global regulatory standards. Responsibilities include both independent execution and supervised handling of complex submissions. Senior Regulatory Associate Remote Jobs
Key responsibilities include:
- Preparing and submitting regulatory applications and supporting documentation for marketing authorization and lifecycle maintenance activities
- Independently handling non-complex regulatory submissions and supporting complex submissions under guidance from senior regulatory leadership
- Supporting initial marketing authorization applications and post-approval variations for EU and other international markets
- Contributing to authoring, reviewing, and maintaining CTD Modules 2 and 3
- Managing regulatory information processing activities with a high level of accuracy, quality, and adherence to timelines
- Maintaining regulatory records, submission trackers, logs, and databases as per internal and client-specific requirements
- Performing quality control reviews of regulatory documents and coordinating internal and external review cycles
- Tracking documents through final submission and delivery to clients or health authorities
- Participating in client meetings and supporting communication related to regulatory deliverables
- Reviewing work completed by Regulatory Associates or junior team members to ensure accuracy and compliance
- Monitoring workload and identifying potential risks to project delivery, with timely escalation when required
- Proposing solutions for non-complex regulatory or project-related challenges
- Supporting training and mentoring of team members as per project needs
- Ensuring completion of all mandatory training and maintaining individual training records
This role requires a high level of accountability, regulatory knowledge, and the ability to manage multiple regulatory activities concurrently. Senior Regulatory Associate Remote Jobs
Eligibility Criteria
Education
- Bachelor’s degree in Pharmacy, Life Sciences, Chemistry, or a related discipline
- Equivalent practical experience may also be considered
Experience
- Minimum 2–3 years of experience in Regulatory Affairs
- Strong hands-on experience with EU market regulatory submissions
- Exposure to APAC and Gulf markets will be considered an added advantage
- Experience supporting initial marketing authorization applications and post-approval variations is essential
- Prior involvement in CTD Module 2 and Module 3 authoring or support is required
Skills Required
- Solid understanding of global regulatory frameworks, particularly EU regulations
- Strong experience in regulatory submission preparation and lifecycle management
- Excellent written and verbal communication skills in English
- Advanced proficiency in Microsoft Office applications
- Strong analytical and problem-solving abilities
- High attention to detail and documentation accuracy
- Ability to work independently with minimal supervision
- Capability to collaborate effectively with cross-functional and global teams
- Strong time management skills with the ability to handle multiple projects simultaneously
Salary & Benefits
- Compensation: As per company norms
In addition to competitive compensation, the organization offers structured career progression, technical and therapeutic training, performance recognition programs, and a supportive work culture focused on professional growth and inclusion. Senior Regulatory Associate Remote Jobs
Selection Process
The hiring process may include:
- Initial profile screening based on regulatory experience
- Technical interview focusing on EU submissions, lifecycle activities, and CTD modules
- Assessment of documentation quality, analytical skills, and communication
- Final HR discussion and offer issuance
Only shortlisted candidates will be contacted during the selection process. Senior Regulatory Associate Remote Jobs
How to Apply
Interested candidates should apply through the official company application channel as specified by the employer.
- Application Mode: Online application via company careers portal
Applicants are advised to clearly highlight EU regulatory experience, post-approval activities, and module-level exposure in their resumes. Senior Regulatory Associate Remote Jobs
Important Dates
- Job Posted On: Posted Today
- Application Status: Currently Open
Early applications are recommended due to the competitive nature of remote and hybrid regulatory roles.
Why Apply for This Pharma Job?
This Senior Regulatory Associate role offers an excellent opportunity for experienced regulatory professionals to work on global EU submissions within a reputed international organization. The role provides exposure to complex regulatory projects, opportunities to mentor junior team members, and flexibility through remote or hybrid working models. For professionals aiming to strengthen their expertise in EU regulatory affairs and progress into senior regulatory leadership roles, this position offers both depth and long-term career potential.
Important Note / Disclaimer
IndiaPharmaJobs.in is an independent job information platform that publishes pharmaceutical and life sciences job opportunities for informational purposes only. We are not affiliated with Syneos Health or any hiring organization. Candidates are advised to verify job details, eligibility criteria, and application procedures directly with the employer. IndiaPharmaJobs.in does not charge any fees for job listings or job applications. Senior Regulatory Associate Remote Jobs
Final Call-to-Action
If you have proven experience in EU regulatory submissions and lifecycle management and are looking to advance your career in global regulatory affairs, this Senior Regulatory Associate opportunity offers a strong platform for professional growth. Eligible candidates are encouraged to apply through the official application process at the earliest. Senior Regulatory Associate Remote Jobs
