Syneos Health®, a global leader in fully integrated biopharmaceutical solutions, is inviting applications for the role of Regulatory Consultant with EU market experience. This remote-based opportunity in India offers an exciting career path for regulatory professionals passionate about driving innovation in clinical development and regulatory operations.
About Syneos Health
With a presence in over 110 countries and a team of 29,000+ professionals, Syneos Health is dedicated to accelerating the delivery of therapies through a unique combination of clinical, medical affairs, and commercial insights. The company’s model centers on collaboration, innovation, and a strong focus on patients and customers.
Work Here Matters Everywhere – This is not just a tagline, but a commitment to employees’ personal and professional growth, inclusion, and purpose-driven work.
Job Title: Regulatory Consultant (EU Market Experience)
Location: Remote – India
Job ID: 25100212
Key Responsibilities
- Serve as a regulatory expert supporting product development projects for the EU market.
- Author and review Module 3 (CMC) documentation with at least 6 years of experience.
- Handle post-approval CMC variations and lifecycle maintenance activities.
- Operate within regulatory systems like RIMS and Veeva Vault, including troubleshooting.
- Contribute to the preparation of regulatory submissions including INDs, MAAs, and briefing packages for health authority interactions.
- Ensure project delivery aligns with timelines, budget, and client expectations.
- Collaborate across multidisciplinary project teams and provide strategic regulatory guidance.
- Support internal and client meetings, training, audits, and proposal development.
Candidate Profile
- Education: BS or PhD in a science-related field or equivalent experience.
- Proven experience in EU regulatory submissions, including electronic CTD submissions.
- Hands-on expertise in authoring CMC documents and working with regulatory software systems.
- Strong verbal and written communication skills in English.
- High attention to detail, project management capability, and problem-solving mindset.
- Team player with the ability to also work independently.
Why Join Syneos Health?
- Access to world-class training and professional development
- A diverse and inclusive work culture
- Global exposure and collaboration with industry leaders
- Competitive compensation and total rewards program
- Be part of a company truly making a difference in healthcare innovation
If you’re ready to elevate your regulatory career with a globally respected biopharmaceutical leader, Syneos Health welcomes your expertise.
Apply now and help transform the future of clinical research and drug development.
