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Dra – Exports Profile

0-2 years
Not Disclosed
10 April 20, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Hiring for DRA – Exports Profile

Designation: DRA – Exports
Experience: Freshers (M.Pharm)
Work Mode: Work from Office (6 Days Working)
Location: Kaushambi, Ghaziabad

Job Overview:
We are looking for enthusiastic and motivated freshers with an M.Pharm qualification to join our Regulatory Affairs (DRA) – Exports team. This is an exciting opportunity for candidates passionate about pharmaceutical regulatory processes to start their career in a dynamic and supportive environment. The role involves supporting the documentation and regulatory requirements for export markets, ensuring compliance with international guidelines and standards.

Key Responsibilities:

  • Assist in the preparation, compilation, and submission of dossiers for regulatory approvals in various export markets.

  • Review and organize technical documents related to product registrations.

  • Support regulatory activities by coordinating with cross-functional teams like Quality Assurance, Quality Control, Production, and R&D.

  • Maintain and update regulatory databases and archives as per standard practices.

  • Ensure compliance with country-specific regulatory requirements for product registration and post-approval changes.

  • Assist in responding to queries from regulatory authorities in a timely and professional manner.

  • Stay updated with global regulatory trends, changes, and requirements to support continuous compliance.

  • Support the senior regulatory team in documentation audits and inspections.

Candidate Profile:

  • Freshers with an M.Pharm degree (specialization in Pharmaceutical Regulatory Affairs or related fields preferred).

  • Strong academic background and understanding of regulatory guidelines and documentation.

  • Good written and verbal communication skills.

  • Ability to work meticulously and maintain high attention to detail.

  • Proficient in Microsoft Office (Word, Excel, PowerPoint).

  • Self-motivated, eager to learn, and able to work collaboratively in a team-oriented environment.

Why Join Us:

  • Opportunity to start your career in a highly respected regulatory role.

  • Exposure to global regulatory requirements and documentation practices.

  • Work in a supportive environment with professional growth opportunities.

  • Direct mentorship and guidance from experienced regulatory professionals.

Application Details:
Interested candidates are invited to share their updated resumes at: hrm@rivpraformulation.com