Instagram
youtube
Facebook

Principal Specialist, Regulatory Operations

2+ years
Not Disclosed
10 Oct. 29, 2024
Job Description
Job Type: Full Time 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 Opportunity: Regulatory Affairs Specialist

Company: Fortrea
Location: [Insert Location]
Job Type: [Insert Job Type]

Company Overview

As a leading global contract research organization (CRO), Fortrea is dedicated to scientific rigor and boasts decades of clinical development experience. We offer pharmaceutical, biotechnology, and medical device customers a comprehensive range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With operations in over 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.

Role Overview

We are seeking a Regulatory Affairs Specialist with a minimum of 7 years of experience in reviewing and approving raw materials and formulations. This role involves understanding, analyzing, and interpreting regulatory requirements throughout the product development life-cycle, ensuring compliance with global regulations such as REACH, DEG/EG, Nitrosamine, elemental impurities, Halal, RSS, and allergens.

Key Responsibilities

  • Review and approve raw materials and their constituent information for completeness and accuracy.
  • Evaluate the potential impact of current guidelines and restrictions on formulations for innovation platforms, new product development, and marketed products.
  • Create ingredient lists according to the appropriate regulatory classification.
  • Prepare impact assessments for proposed formulation changes and develop remedial strategies.
  • Support the preparation of new ingredient listing submission documents.
  • Review changes outlined in change control forms for raw materials used in cosmetic and non-NDA drugs marketed globally, completing assessments and circulating for approval.
  • Ensure compliance of fibers and non-woven materials with client internal guidelines.
  • Prepare technical justifications for stability testing related to packaging material changes, adhering to regulations.

Qualifications

  • Strong knowledge of global regulations, including OECD and ICH Q3D.
  • Experience in regulatory compliance for EU, US, ASEAN, China, and Arab countries.
  • Proven ability to navigate diverse regulatory environments and assess formulations for compliance.
  • Excellent analytical skills and attention to detail.

Why Join Fortrea?

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace that nurtures personal growth, allowing you to make a meaningful global impact.


Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We strive for diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications without regard to race, religion, color, national origin, gender, family status, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

For more information about how we collect and store your personal data, please see our Privacy Statement.