Reg Affairs Officer 2

0-1 years

Not Disclosed

Bengaluru

10 Dec. 5, 2024

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

Here’s a refined version of the job description for clarity and engagement:

Position: Regulatory Submissions Specialist
Company: IQVIA
Location: EU Time Zone (Preferred)

About IQVIA
IQVIA is a global leader in clinical research services, healthcare insights, and life sciences intelligence. We leverage our expertise to connect data, technology, and services, accelerating the development and delivery of innovative medical treatments to improve patient outcomes worldwide.

Key Responsibilities:
As a Regulatory Submissions Specialist, you will play a pivotal role in managing and coordinating regulatory submissions to ensure compliance and timely delivery. Your responsibilities include, but are not limited to:

Submission Management:
- Develop submission content plans in regulatory document management systems or health authority portals (e.g., IRIS, CTIS).
- Monitor submission progress to ensure deadlines are met.
Document Preparation and Authoring:
- Author administrative sections, such as cover letters and submission forms, for routine submissions.
- Manage the preparation of documents for various submissions, including:
  - Investigator submissions.
  - Annual reports (e.g., PSURs, DSURs, Orphan Drug reports).
  - IND Safety Reports.
Cross-Functional Coordination:
- Collaborate with other functional groups to ensure cohesive document preparation.
- Coordinate submission documents through review cycles.
- Provide guidance for uploading and managing documents in regulatory submission systems.
Team Meetings and Affiliate Support:
- Support affiliates as needed.
- Organize and coordinate team meetings for major and routine submissions in alignment with the Global Regulatory Lead (GRL) and EU/US Regulatory Strategy Leads.
Submission Review:
- Oversee submission completeness and coordinate with the Publishing Lead on document statuses and timelines.
- Review published outputs for quality and accuracy.
Operational Excellence:
- Participate in improvement initiatives and operational excellence projects.

Qualifications:

Proficiency in managing regulatory documents and familiarity with submission systems such as IRIS and CTIS.
Strong organizational and communication skills.
Experience coordinating cross-functional activities in a regulatory or healthcare setting.
Prior experience with regulatory submissions, such as PSURs, DSURs, and IND reports, is a plus.
Flexibility to work in EU time zones, as requested by the client.

Why IQVIA?
IQVIA offers a dynamic work environment with opportunities to collaborate with experts across the healthcare and life sciences industries. Our mission-driven approach and global reach provide unparalleled opportunities for professional growth and development.

Learn more about IQVIA and explore opportunities to grow your career: IQVIA Careers

This version ensures clarity and structure while maintaining professionalism, catering to potential applicants and meeting the client’s expectations. Let me know if you’d like additional refinements!

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Reg Affairs Officer 2

Job Description

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