About this role
Job description - Regulatory Support Specialist
Job Summary:
- Collection information and prepare the documentation to support the HGRAC application and submission.
- Provides support and assistance in terms of reviews data for accuracy and compliance to applicable SOPs and regulations. Maintains and expands knowledge of regulatory requirements, SOP requirements, and client requirements.
- Responsible for communicating with internal teams to resolve any issues during the submission process.
Essential Job Duties:
- Assists to the collect information, prepare documentation and upload to complete the HGRAC submission.
- Possesses a strong understanding of HGRAC policy and departmental processes. And proactively communicates with internal teams to resolve any issues during the submission process.
- Follow up the HGRAC application status of the project and the problems during the application process, if needed, to prevent recurring citations, problems, or errors.
- Prepares and supports HGRAC inspections.
- Assisting a working knowledge of client SOPs and requirements. Ensure that the data reviewed comply with applicable departmental procedures and HRGAC policies.
Requirements (Experience, Education, Qualifications and Skills)
Experience:
- The candidate with 2 years’ experience about HGRAC submission in the Pharmaceutical industry in Regulatory Affairs or Drug Development is preferred.
Education:
- Bachelor’s Degree in Life Sciences or equivalent, possibly with a higher qualification.
Skill:
- Required outstanding communication and negotiation skills.
- Be able to read, write and speak English proficiently
Job description - Regulatory Support Specialist
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
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Other facts
About Labcorp
Laboratory Corporation of America Holdings is a life sciences company that is integrated in guiding patient care, providing clinical laboratory and end-to-end drug development services. The Company operates as a healthcare diagnostics company. The Company operates through two segments: LabCorp Diagnostics (LCD) and Covance Drug Development (CDD). The LCD segment is an independent clinical laboratory business, which offers menu of frequently requested and specialty testing through an integrated network of primary and specialty laboratories across the United States. The CDD segment offers drug development services, and provides a range of drug research and development (R&D) and market access services to biopharmaceutical companies and medical device companies across the world. It serves a range of customers, including managed care organizations (MCOs), biopharmaceutical companies, governmental agencies, physicians and other healthcare providers.
What you'll do
- The Regulatory Support Specialist is responsible for collecting information, preparing documentation, and supporting the HGRAC application and submission process. They will also communicate with internal teams to resolve issues and ensure compliance with regulatory requirements.
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