Regulatory Affairs Team Lead

10 to 15 years of RA experience years

Preffered by Company

Ahmedabad

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

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Regulatory Affairs Team Lead

Job Description

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