Regulatory Associate Job Opportunity – at Syneos Health, Apply Now!
Are you a detail-oriented regulatory professional passionate about navigating global health regulations? Join Syneos Health as a Regulatory Associate (EU Market) and play a pivotal role in accelerating life-saving therapies across global markets. This is a fantastic remote opportunity for professionals with a background in Regulatory Affairs or Pharmaceutical Sciences to contribute to impactful submissions and drive compliance across the EU, US, LATAM, APAC, and beyond. Be part of a dynamic global team reshaping healthcare.
- Job Position: Regulatory Associate (EU Market) – Remote | Syneos Health
- Location: India – Remote
- Job ID: 25100207
- Department: Regulatory Affairs
- Job Type: Full-Time, Home-based
About The Company
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Job Description
Syneos Health® is a global biopharmaceutical solutions organization helping customers transform their ideas into reality. With a presence in over 110 countries and a network of 29,000+ professionals, we’re passionate about accelerating clinical success and patient outcomes.
We are currently hiring a Regulatory Associate for the EU Market to work remotely from India.
Regulatory Associate Job Opportunity – Key Responsibilities
- Prepare, review, and submit global CMC dossiers, variations, and post-approval changes.
- Support regulatory submission activities including INDs, NDAs, MAAs, DMFs, and MATs.
- Conduct regulatory research to support clinical development and orphan drug requests.
- Assist with the creation and maintenance of regulatory documents, SOPs, and records.
- Collaborate cross-functionally across departments to gather and compile necessary data.
- Perform quality checks and support inspection-readiness documentation.
Regulatory Associate Job Opportunity – Required Qualifications
- Education: Master’s in Pharmacy or a related life sciences/healthcare discipline.
- Experience: Minimum 1 year in Regulatory Affairs (Global CMC). Internship experience is also considered.
- Skills:
- Knowledge of regulatory procedures in EU, US, LATAM, APAC, and China.
- Strong communication, research, and documentation skills.
- Proficiency in MS Office and ability to manage multiple concurrent projects.
- Fluency in written and spoken English.
Why Join Syneos Health?
- Total Self Culture: Be your authentic self while making a global impact.
- Career Growth: Tailored development programs, learning resources, and recognition platforms.
- Global Reach: Contributed to 94% of all Novel FDA Approvals over the last 5 years.
- Remote Flexibility: Work-from-home setup with global collaboration.
- Inclusive Environment: Diversity, equity, and inclusion are central to our mission.
Additional Info
- This is a home-based position open to candidates across India.
- Strong preference for candidates with internship or hands-on experience in Regulatory CMC.
- The role reports to the Global Regulatory Affairs team and collaborates across functions.
Keywords: Regulatory Associate, EU Market, Job Opportunity, Homebased, Syneos Health, Clinical Development
