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

• Minimum 1 year of experience in Global Regulatory Affairs.
• Hands-on experience in the preparation and review of global CMC dossiers, variation applications, and post-approval changes.
• Solid understanding of regulatory markets and authorization dossier applications across regions including: EU, US, LATAM, APAC, Middle East, Africa, and China.
• Proven ability to work effectively in a fast-paced, team-oriented environment.
• Strong aptitude and attitude to learn and grow within the regulatory domain.
• Candidates with internship experience in Regulatory Affairs (CMC) will be given preference.
•  ​Assists with preparation of product development documents including gap analyses and clinical development plans.
• ​Assists with preparation of regulatory submission documents including components of investigational new drug applications (INDs), new drug applications or new marketing applications (NDAs/MAAs), drug master files (DMFs), variations, renewals, marketing authorization transfers (MATs) and other lifecycle maintenance activities, according to current government regulations and guidelines.
• ​Conducts regulatory research to identify regulatory precedents and to support the preparation of orphan drug designation requests.
• ​Performs quality checks on related documents.
• ​Assists with submissions of other regulatory documents and other regulatory research as needed.
• ​Assists clients, customers, or others with general information
• ​Gathers, compiles, analyzes, and reports information.
• ​Gathers information, searches files and records, and makes personal contacts to obtain specific information in order to prepare detailed reports and compose routine correspondence.

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