work From Home Regulatory Associate – EU Market at Syneos Health

Regulatory Associate – EU Market | Remote Job at Syneos Health | M.Pharm/M.Sc. Graduates Apply Now

Home-Based Regulatory Affairs Job for M.Pharm or M.Sc. Graduates with 1+ Year Experience

Syneos Health, a global leader in integrated biopharmaceutical solutions, is hiring a Regulatory Associate (EU Market) for a remote, India-based position. This opportunity is ideal for professionals with at least 1 year of experience in Global Regulatory Affairs, particularly those with hands-on exposure to CMC dossiers, variation applications, and post-approval regulatory changes.

Key Responsibilities of Regulatory Associate

Global Regulatory Documentation

• Prepare, compile, and review regulatory submission documents for EU markets.
• Support dossier compilation for investigational new drug applications (INDs), NDAs/MAAs, drug master files (DMFs), and lifecycle management.
• Manage marketing authorization variations, renewals, and transfer documentation.

Regulatory Strategy & Compliance

• Ensure regulatory compliance with global regulations including EU, US, LATAM, APAC, Middle East, and China.
• Conduct regulatory research and assist in orphan drug designation documentation.
• Maintain updated knowledge of current/pending global regulatory legislation.

Cross-Functional Support

• Collaborate with clinical and regulatory stakeholders across departments.
• Assist with preparation of development plans, data reports, and internal audits.
• Ensure data integrity, regulatory accuracy, and submission timelines are met.

Who Should Apply?

Educational Qualifications

• Master’s in Pharmacy (M.Pharm) or Master’s in Science/Healthcare field preferred.

Experience Requirements

• Minimum 1 year experience in Regulatory Affairs.
• Candidates with CMC internship experience are preferred.

Skills & Competencies

• Advanced MS Office and documentation skills
• Strong communication and analytical skills
• Proven ability to manage multiple projects simultaneously

Why Join Syneos Health?

• Contributed to 94% of all FDA-approved novel drugs in the last 5 years
• Global presence in 110+ countries with 29,000+ employees
• Culture focused on diversity, inclusivity, and professional development

Application Process

To apply, visit the official job portal:
👉 Apply Now

Quick Reference Table

Apply for a remote Regulatory Associate role at Syneos Health for M.Pharm/M.Sc. with 1+ year experience. EU Market CMC dossier knowledge required.

Regulatory Affairs Associate Remote Job | Syneos Health Hiring M.Pharm/M.Sc. with 1+ Yr Exp

Tagged as: Global Pharma Jobs, Good Clinical Practice (GCP), Pharmaceutical Careers, Pharmaceutical Jobs