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Regulatory Affairs Team Lead

Pharmazone
Pharmazone
10 to 15 years of RA experience years
Preffered by Company
1 July 15, 2024
Job Description
Job Type: Full Time Education: BSC, MSC, B Pharma, M Pharma, Pharma 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: Regulatory Affairs - Team Lead

 

Location: Ahmedabad

Designation: Senior Manager

Candidate Specifications:

  • Experience:
    • Total of 10 to 15 years in Regulatory Affairs (RA).
    • At least 6 years of experience in regulated markets such as the USA, EU, UK, or CA.
    • Multiple market experience is an advantage.
  • Skills:
    • Excellent written and verbal English communication skills.
    • Proven team handling experience.
    • Familiarity with eCTD submissions.

 

Job Profile:

  • Act as a regulatory lead.
  • Responsible for the execution and delivery of all RA projects.
  • Assist in and perform dossier drafting and compilation for all markets.
  • Perform quality checks on all output from the RA team.
  • Responsible for all regulatory submissions from the RA team.
  • Represent project status to the client and the RA Head of Department (HOD).
  • Mentor less experienced or new staff members.

 

Past Experience:

  • Required to have 6+ years of experience in regulatory market (USA/EU/CA/UK) dossier submission.

Experience: 10 - 15 years

Qualification: B. Pharm / M. Pharm

Apply: Share your resume mentioning the JOB CODE at hr@pharmazones.com