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Sr Reg Affairs Spec

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: Lead Regulatory Affairs Specialist (Global/Regional Projects)

Location: Office-Based
Work Schedule: Standard (Mon-Fri)


Company Overview:

We are a leading global provider of clinical trial services, offering comprehensive regulatory and strategic solutions to support product development from preclinical through registration and optimization. With expertise across a wide range of therapeutic areas, we focus on delivering efficient, innovative services that meet local, regional, and ICH regulatory requirements.


Position Overview:

As a Lead Regulatory Affairs Specialist, you will oversee several countries/projects, providing strategic regulatory intelligence and guidance to ensure smooth product development from early stages through to registration. You will be responsible for preparing client deliverables, liaising with internal and external clients, and ensuring compliance with regulatory standards across a broad range of activities, including clinical trials and product lifecycle management. This role requires strong leadership and project management skills to support the regulatory 'green-light' process, authorizing the shipment of investigational products to sites and managing essential documentation globally.


Key Responsibilities:

  • Regulatory Leadership: Act as the lead for multiple countries/projects, providing innovative regulatory solutions and strategic intelligence.
  • Client Interface: Serve as a key liaison between clients and internal teams, ensuring effective communication and regulatory compliance.
  • Green-Light Process: Collaborate with clinical management and site activation teams to ensure efficient regulatory processes for initial investigational product shipments.
  • Essential Document Review: Review and approve essential clinical trial documents to ensure compliance with GCP regulations and local/national requirements, including:
    • Principal Investigator’s CV
    • Ethics committee approval documentation
    • Ethics committee approved Informed Consent Forms (ICFs)
    • Regulatory authority approval documentation
    • Protocol signature pages
    • FDA Form 1572 / Clinical Studies Information Form (CIF)
    • Financial disclosure forms for the principal investigator
  • Regulatory Expertise: Provide strategic guidance to ensure that all regulatory requirements are met throughout the product lifecycle, from clinical trial authorization to post-market.
  • Document Compliance: Ensure compliance with ICH and global regulatory guidelines, maintaining high standards for quality control and documentation.
  • Project Coordination: Manage and track timelines, priorities, and resources to ensure deliverables are met within set timelines.

Qualifications & Skills:

  • Education: Bachelor’s degree or equivalent and relevant academic or vocational qualification.
  • Experience: At least 8+ years of experience in regulatory affairs or clinical trials, providing expertise across global and regional projects.
  • Language Skills: Excellent English communication skills (written and oral); proficiency in local language(s) where applicable.
  • Attention to Detail: Strong editorial, proofreading, and quality control skills.
  • Interpersonal Skills: Ability to work effectively with cross-functional teams and stakeholders, both internally and externally.
  • Technical Skills: Proficient in Microsoft Word, Excel, PowerPoint; ability to adapt to new technologies.
  • Project Management: Strong organizational and time management skills to manage multiple projects and adapt to changing priorities.
  • Negotiation Skills: Capable of negotiating regulatory strategies and requirements with clients and stakeholders.
  • Regulatory Expertise: Deep understanding of global, regional, and national regulatory requirements for clinical trials and product lifecycle management, with expertise in ICH and other global regulatory guidelines.

Additional Information:

All personal information will be kept confidential in accordance with EEO guidelines.