Regulatory Associate – EU Market (Remote, India)
Job Summary:
Syneos Health is hiring a Regulatory Associate (EU Market) for a remote, India-based opportunity. This role is perfect for professionals with at least 1 year of experience in global regulatory affairs, particularly in preparing and reviewing CMC dossiers and handling post-approval changes across international markets. You'll work in a dynamic global biopharmaceutical environment where innovation, quality, and regulatory compliance converge to drive impactful healthcare outcomes.
Key Responsibilities:
Prepare and review global CMC dossiers, variation applications, and lifecycle maintenance submissions.
Support documentation for INDs, NDAs/MAAs, DMFs, renewals, and marketing authorization transfers.
Conduct regulatory research across EU, US, LATAM, APAC, Middle East, Africa, and China.
Assist in developing gap analyses and product development documents.
Perform quality checks and assist with orphan drug designation submissions.
Collaborate with clients and internal teams to meet regulatory deadlines and standards.
Analyze and report regulatory data, compose correspondence, and maintain documentation quality.
Required Skills & Qualifications:
Master's in Pharmacy (preferred) or Master’s in science/healthcare field.
Minimum 1 year of experience in global regulatory affairs; internships in Regulatory CMC preferred.
Strong knowledge of international regulatory environments, especially the EU market.
Proficiency in Microsoft Office applications.
Strong analytical skills and attention to detail.
Excellent communication and interpersonal skills.
Fluent in spoken and written English.
Ability to work independently and across cross-functional teams.
Perks & Benefits:
Competitive salary and total rewards program
Global learning and development programs
Career advancement opportunities
Inclusive and diverse work culture
Full-time remote flexibility
Exposure to high-impact global projects
Supportive leadership and team environment
Company Overview:
Syneos Health is a global biopharmaceutical solutions provider offering clinical development, medical affairs, and commercial services. Known for partnering on 94% of all novel FDA-approved drugs in the last 5 years, Syneos Health leads innovation across 110+ countries.
Work Mode:
Remote (India-based)
Call to Action:
Are you ready to advance your regulatory career in a global, mission-driven organization? Apply now to join Syneos Health and help accelerate life-changing therapies to market.
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Siliguri |Illinois :
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Canada |Quebec :
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Zaventem |South America :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Tallinn |Hà Nội :
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Prague |Chile :
Santiago |Bosnia and Herzegovina :
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