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Expert Medical Regulatory Writer

8+ years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Education: None Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Description: Expert Medical Regulatory Writer

Position: Expert Medical Regulatory Writer

📍 Location: Hyderabad, India
Job Type: Permanent
📅 Posted On: Feb 06, 2025 | Closing Date: Apr 30, 2025

Your Role:

As an Expert Medical Regulatory Writer, you will be responsible for authoring and reviewing high-quality clinical and safety documents for regulatory submissions, supporting marketing authorization applications, renewals, and maintenance activities. You will provide expert guidance on complex clinical study reports (CSR), CTD submission documents, periodic safety updates, risk management plans, and regulatory briefing packages.

This role requires independent decision-making, mentoring junior writers, and collaborating with cross-functional teams including Clinical Trial Teams (CTT), Global Clinical Teams (GCT), and Pharmacovigilance Teams.

💡 Key Responsibilities:

🔹 Regulatory Writing & Documentation:

  • Author and edit high-quality clinical and safety documents (e.g., CSR, CO, SCE, SCS, SCP, SBP, PBRER, ACO, RMP, HAQs, and Briefing Packages).
  • Ensure timely submission of documents in compliance with global regulatory standards.
  • Contribute to key messaging meetings and complex regulatory submissions.

🔹 Strategic Collaboration & Team Leadership:

  • Act as an SME for clinical deliverables, mentor junior writers, and provide expert peer review.
  • Work closely with Scientific Communication, Pharmacovigilance, and Regulatory Affairs teams.
  • Proactively liaise with Medical, Biostats, Legal, and Corporate Affairs departments to ensure compliance and quality.

🔹 Process & Compliance:

  • Ensure alignment with regulatory requirements and company standards across multiple countries.
  • Participate in regulatory planning, stakeholder engagement, and cross-functional discussions.
  • Support the development of trial transparency documents and product alerts.

Who You Are:

✔️ Experience:

  • 8+ years in regulatory writing within the pharmaceutical or healthcare industry.
  • Extensive knowledge of global drug registration and regulatory requirements.

✔️ Education:

  • Advanced degree in Life Sciences, Pharmacy, or Medical discipline (PhD, MSc, MBBS, BDS, BAMS, BHMS, MD).

✔️ Skills & Competencies:

  • Strong project management & stakeholder engagement skills.
  • Ability to work independently and lead project teams.
  • Expertise in global regulatory documentation and submissions.
  • Excellent written and verbal English communication skills.

🚀 Join us in driving regulatory excellence and shaping the future of healthcare! Apply now to be part of our mission at Sanofi.