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Global Regulatory Specialist

3-4 years
Not Disclosed
10 March 18, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./Pharm D/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

We Are Hiring! Join Chisquare Labs as a Global Regulatory Specialist!

About the Company:
Chisquare Labs is a trusted name in the life sciences and healthcare industry, offering innovative solutions to clients globally. Our commitment to excellence, regulatory compliance, and cutting-edge expertise ensures a rewarding career for professionals who are passionate about regulatory affairs.

Job Title: Global Regulatory Specialist
Job Type: Full-Time/Part-Time, Remote
Location: Remote (Work from Home)

About the Role:
We are seeking an experienced Global Regulatory Specialist to join our team and contribute to the preparation and submission of global regulatory documents. The ideal candidate should have expertise in global regulatory submissions, ensuring compliance with international standards and guidelines.

Key Responsibilities:

  • Prepare, review, and submit regulatory documents for global submissions.

  • Ensure compliance with international regulations, ICH guidelines, and local regulatory requirements.

  • Liaise with regulatory authorities to obtain necessary approvals and address queries.

  • Monitor changes in global regulatory policies and implement necessary updates.

  • Collaborate with internal teams to ensure timely submission and approval of applications.

Qualifications:

  • Bachelor's Degree in:

    • Pharm D

    • Medicine

    • Or a related field,
      OR

  • Master's Degree in:

    • Regulatory Affairs

    • M Pharm

Experience:

  • 3 to 4 years of experience in:

    • Global Regulatory Submissions

    • Regulatory Compliance and Document Management

Why Join Chisquare Labs?

  • Remote Work Flexibility – Enjoy the convenience of working from home.

  • Professional Growth Opportunities – Advance your career in a fast-paced, global environment.

  • Collaborative and Supportive Culture – Work with a team of industry experts.

Interested in Joining Our Team?
Send your resume to
careers@chisquarelabs.com with the job title in the subject line!