Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Drug Regulatory Affairs Executive (Male)

Ananta Medicare Limited
Ananta Medicare Limited
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.