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Sr Reg Affairs Spec

0-2 years
Not Disclosed
10 Nov. 11, 2024
Job Description
Job Type: Full Time Remote 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

Job Title: Senior Regulatory Affairs Specialist

Location: Global (Remote/Flexible)
Job Type: Full-Time


About the Role:

We are seeking a Senior Regulatory Affairs Specialist to join our dynamic global team. This is an exceptional opportunity to advance your regulatory career and expertise within the context of global clinical trials. You will be a key team member, providing regulatory leadership, developing strategies, and coordinating regulatory affairs activities for clinical trials across all phases (Phase 1 to 4).

As part of our global Regulatory Affairs department, you will collaborate with cross-functional teams and be at the forefront of regulatory strategy, ensuring compliance, facilitating communication with sponsors, and providing guidance on regulatory submissions and documents. You will also serve as the primary liaison between internal teams, clients, and regulatory agencies, ensuring all aspects of regulatory requirements are met.


Key Responsibilities:

  • Global Regulatory Submissions: Lead the preparation, assembly, and submission of global regulatory documents to ensure compliance with applicable regulatory guidelines.
  • Client and Regulatory Agency Liaison: Interact with sponsors and regulatory agencies to provide regulatory advice, guidance, and strategic intelligence.
  • Document Review and Assessment: Review and assess clinical trial regulatory documents and scientific literature to ensure accuracy and compliance.
  • Project Management: Manage project teams, coordinate tasks, and contribute to the planning and preparation of regulatory documents for clinical trials.
  • Cross-Department Collaboration: Represent regulatory affairs in project meetings, launch meetings, and team reviews, ensuring regulatory requirements are incorporated into overall project planning.
  • Client Engagement: Lead and report on client and regulatory agency meetings, ensuring all requirements and expectations are clearly understood and communicated.
  • Business Development: Support business development efforts by contributing to regulatory proposals, including participation in bid defense meetings.

Qualifications:

  • Education: Bachelor's degree in a relevant field (advanced degree preferred). Equivalent academic/vocational qualifications or relevant experience will also be considered.
  • Experience: Proven experience in regulatory affairs, particularly within the context of global clinical trials (Phases 1-4).
  • Knowledge:
    • Deep knowledge of global clinical trials landscape and regulatory requirements.
    • Expertise in ICH guidelines and other global regulatory frameworks.
    • Familiarity with regulatory affairs procedures for clinical trial authorization across regions and countries.
  • Skills:
    • Excellent Communication: Proficient in English (both written and oral). Additional language proficiency is a plus.
    • Attention to Detail: Strong editorial and proofreading skills to ensure the highest quality regulatory documents.
    • Interpersonal Skills: Exceptional ability to work collaboratively in a team environment and act as a liaison between departments and clients.
    • Project Management: Strong organizational and time management skills, with the ability to manage multiple projects simultaneously.
    • Technical Skills: Proficient in Microsoft Word, Excel, PowerPoint, and capable of learning new technologies as needed.
    • Analytical Thinking: Strong investigative, problem-solving, and analytical abilities.

Why Join Us?:

This is a fantastic opportunity to enhance your career in regulatory affairs within a global clinical trial setting. You will be part of a forward-thinking company where your expertise will be valued, and you will work alongside a passionate team focused on delivering high-quality, innovative solutions to the clinical research landscape.


What We Offer:

  • Competitive salary and benefits package.
  • Opportunities for career growth and professional development.
  • A supportive, collaborative, and innovative work environment.
  • Global exposure to the clinical trials process across various therapeutic areas.

How to Apply:
Please submit your CV in English to be considered for this exciting opportunity.


Company Statement:
We are an Equal Opportunity Employer, and we welcome candidates from all backgrounds to apply.