Regulatory Associate (EU Market) – Homebased
Job Summary:
Syneos Health is hiring a Regulatory Associate (EU Market) for its Gurgaon office (homebased role). This position involves supporting global regulatory submissions, preparing CMC dossiers, and ensuring compliance with EU, US, and other regional regulatory standards. Ideal for candidates with a background in pharmacy or life sciences and at least 1 year of regulatory affairs experience.
Key Responsibilities:
Prepare and review global CMC dossiers, variation applications, and post-approval changes.
Assist in drafting regulatory submission documents including INDs, NDAs/MAAs, DMFs, variations, renewals, and MATs.
Conduct regulatory research and prepare orphan drug designation requests.
Perform quality checks and ensure accuracy in all regulatory documentation.
Compile and analyze data for detailed reports and regulatory correspondence.
Maintain compliance with global regulatory guidelines and standards.
Support cross-functional teams with regulatory insights and updates.
Required Skills & Qualifications:
Master’s degree in Pharmacy (preferred) or Science/Healthcare field.
Minimum 1 year of experience in global regulatory affairs (internship experience in CMC preferred).
Strong knowledge of EU, US, LATAM, APAC, Middle East, Africa, and China regulatory requirements.
Excellent communication and interpersonal skills.
Advanced proficiency in Microsoft Office applications.
Strong analytical, project management, and time management skills.
Ability to work independently as well as in cross-functional teams.
Perks & Benefits:
Career development programs and continuous learning.
Remote/homebased working flexibility.
Exposure to global regulatory markets and processes.
Inclusive and collaborative workplace culture.
Comprehensive rewards and recognition programs.
About Syneos Health:
Syneos Health is a leading biopharmaceutical solutions organization, collaborating on 94% of all novel FDA-approved drugs and 95% of EMA-authorized products. With a global presence in 110 countries, Syneos Health drives innovation to accelerate clinical and regulatory success.
Work Mode: Homebased (Remote – Gurgaon, India)
Call-to-Action:
Interested in advancing your career in global regulatory affairs? Apply now to join Syneos Health and be part of a team driving regulatory excellence worldwide.
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