work From Home Regulatory Associate – EU Market at Syneos Health

work From Home Regulatory Associate – EU Market at Syneos Health
  • Full Time
  • Remote

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
work From Home Regulatory Associate – EU Market at Syneos Health
work From Home Regulatory Associate – EU Market at Syneos Health

Application Process

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


Quick Reference Table

Company NameCurrent Vacancies in Departments
Syneos HealthRegulatory Affairs – EU Market
Required EducationExperience Required
M.Pharm / M.Sc. in Life SciencesMinimum 1 Year
Location
Remote (India)

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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

To apply for this job please visit www.syneoshealth.com.


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