Regulatory Manager (CMC – EU & Japan/China) | Gurugram, India – Hybrid
Job Summary
Syneos Health, a leading biopharmaceutical solutions provider, is hiring a Regulatory Manager (CMC) with expertise in EU and Asian markets (Japan/China). This hybrid role based in Gurugram is ideal for experienced professionals in regulatory affairs with a focus on Chemistry, Manufacturing, and Controls (CMC) for global submissions. Join a global team delivering high-impact regulatory strategies and shaping drug development across diverse markets.
Key Responsibilities
Lead and manage regulatory CMC activities for submissions to EU, Japan, and China authorities.
Collaborate with cross-functional teams to prepare, compile, and submit high-quality regulatory documents.
Ensure compliance with regional guidelines and regulatory expectations.
Provide strategic input and regulatory risk assessment on global CMC matters.
Monitor and interpret changes in regulations in target markets and adapt strategies accordingly.
Engage with external partners and regulatory agencies as necessary.
Maintain accurate records of submissions and communication with health authorities.
Required Skills & Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related discipline.
Strong knowledge of CMC regulatory requirements for EU and Asian markets.
Minimum 5+ years of experience in regulatory affairs (CMC).
Familiarity with eCTD submissions, module 3 documentation, and local regulatory guidelines.
Excellent project management, communication, and organizational skills.
Ability to work across time zones and collaborate in a global matrix environment.
Perks & Benefits
Hybrid work model with flexibility and work-life balance.
Global exposure to international regulatory frameworks.
Professional development and technical training programs.
Inclusive and collaborative culture with 29,000+ professionals across 110 countries.
Total rewards and recognition system tailored for career growth.
About Syneos Health
Syneos Health is a globally recognized biopharmaceutical services organization known for accelerating drug development and commercialization. With deep experience in clinical operations, regulatory affairs, and medical affairs, the company partners with top pharma and biotech firms worldwide.
Work Mode
Hybrid – Gurugram, India
Call to Action
Are you ready to lead regulatory strategy in a global setting? Apply now for the Regulatory Manager (CMC) role at Syneos Health and be a part of cutting-edge drug development across EU and Asia. Don’t miss this opportunity to take your regulatory career global—submit your application today.
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Japan | Saitama |Tokyo :
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