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Specialist - Regulatory Affairs

Merck Kgaa
Merck KGaA
2-3 years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: B.Pharm/M.Pharm/Pharam.D 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 Title: Specialist - Regulatory Affairs
Job ID: 282175
Location: Mumbai, Maharashtra, India
Job Type: Full-Time


Job Description

Join Merck Group as a Specialist in Regulatory Affairs and support India-specific regulatory activities and product-related processes. This role plays a key part in ensuring compliance with regulatory requirements and contributing to business objectives in the APAC region.


Key Responsibilities

Regulatory Activities and Maintenance

  • Maintain product registrations and licenses in RA systems (e.g., SharePoint, Veeva Vault).
  • Perform labeling reviews and assist in project creation within the Artwork Management system (WebCenter).
  • Ensure timely submission of renewals, site registrations, and minor product submissions to Health Authorities in APAC countries.
  • Collect regulatory intelligence for relevant countries and update the Country Regulatory Tool system.
  • Generate reports, manage vendor payments, and address country-specific requests.

Operational Support

  • Facilitate sample collection requests via the K2 system.
  • Provide cross-functional regulatory support and participate in regional/global hub initiatives.
  • Review and revise hub processes to drive efficiency.

Strategic and Dossier Management

  • Align submission strategies with country-specific requirements for site registrations.
  • Assist in preparing, submitting, and tracking applications for renewals and product maintenance.
  • Ensure timely dispatch and updates related to dossier submissions.

Who You Are

Qualifications and Experience

  • Bachelor’s or Master’s degree in Pharmacy or D.Pharma.
  • 2–3 years of experience in the Indian Regulatory Market.
  • Familiarity with CDSCO, Import, and State FDA regulations.

Skills

  • Fluent in written and spoken English.
  • Proficient in regulatory intelligence and RA system tools.
  • Strong organizational and communication skills.
  • Ability to work collaboratively within a diverse, matrixed organization.

What We Offer

  • A global team that values innovation, diversity, and inclusion.
  • Opportunities for personal and professional growth.
  • A supportive culture that celebrates different perspectives and backgrounds.

Apply now and become a part of our mission to champion human progress and innovation!