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Drug Regulatory Affairs Executive (Male)

0-2 years
Not Disclosed
10 Oct. 30, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Position Overview

We are seeking a skilled professional with technical expertise in dossier compilation (CTD, ACTD) for European, CIS, and ASEAN countries. The ideal candidate will have a strong understanding of regulatory guidelines and pharmacopoeia, along with excellent communication and analytical skills.

Key Responsibilities

  • Dossier Compilation & Review: Independently compile and review dossiers for both Finished Products and APIs (CTD, eCTD, ACTD), and respond to subsequent queries.
  • Regulatory Documentation: Maintain and update regulatory documents and records.
  • Cross-Department Coordination: Collaborate with the plant R&D Team for AMD, AMV, Tech Transfer, and Stability Charging Dates.
  • Technical Documentation: Prepare all technical documents for dossiers, including package inserts and drug-drug interaction rationales.
  • Artwork Review: Review artwork for regulatory submissions.
  • Regulatory Submissions: Prepare CTD and ACTD dossiers and file submissions with regulatory authorities.
  • Product Assessments: Conduct assessments of new or revised products.
  • Complaint Management: Manage documentation related to complaints, including investigations and closures.
  • Regulatory Inquiries: Respond to inquiries from regulatory bodies.
  • Coordination: Work with relevant departments to arrange necessary documents and coordinate with courier agencies for dossier/sample dispatches.
  • Submission Tracking: Make timely entries for submissions and dispatches.
  • Contract Drafting: Demonstrate hands-on experience in drafting Non-Disclosure Agreements and assist in resolving regulatory matters.

Qualifications

  • Education:
    • UG: B.Pharma in Pharmacy
    • PG: M.Pharma in Pharmacy
  • Experience: Proven experience in regulatory affairs, with knowledge of ICH guidelines and bioequivalence evaluation.

Skills Required

  • Technical Knowledge: Strong understanding of dossier compilation and regulatory requirements for medicines and food supplements.
  • Communication Skills: Excellent verbal and written communication skills.
  • Analytical Skills: Strong analytical skills with a focus on accuracy and detail.
  • Self-Motivated: Enthusiastic and self-driven with the ability to work independently.
  • Flexibility: Willingness to travel and meet with manufacturing plant representatives as needed.
  • Microsoft Office Proficiency: Proficient in Microsoft Word, Excel, and PowerPoint; good data management skills.

Employment Details

  • Role: Regulatory Affairs Compliance
  • Industry Type: Pharmaceutical & Life Sciences
  • Department: Legal & Regulatory
  • Employment Type: Full Time, Permanent
  • Role Category: Corporate Affairs

If you possess the qualifications and are eager to contribute to our regulatory affairs team, we encourage you to apply.