Regulatory Compliance Specialist

2+ years

Not Disclosed

Remote, USA

10 Jan. 17, 2025

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

Regulatory Compliance Specialist – GSK
Location: USA – Pennsylvania – King of Prussia
Posted Date: January 14, 2025

Are you ready to play a key role in ensuring regulatory compliance in a dynamic biopharmaceutical environment? GSK is seeking a Regulatory Compliance Specialist to support the site’s regulatory compliance programs. This role provides the opportunity to work on regulatory submission processes, change and deviation management, and communicate key regulatory intelligence to the site.

Role Overview:
As a Regulatory Compliance Specialist, you will collaborate with the Regulatory Compliance Lead to ensure compliance objectives are met. Your role will involve reviewing technical changes, supporting regulatory meetings, assisting with audits, and promoting a culture of compliance awareness across the site. You will also manage communications with regulatory agencies and coordinate efforts to keep mandatory licenses and registrations current.

Key Responsibilities:

Review proposed technical changes via the Change Control System and assess their impact on regulatory submissions.
Support Change Owners in Regulatory Implementation Strategy (RIS) meetings for Change Controls with regulatory and supply impact.
Participate in quality-related audits, including regulatory, corporate, and internal audits, and assist with correspondence with regulatory agencies.
Promote regulatory compliance trends and continuous improvement initiatives at the site.
Support and/or assure completion of annual product reviews.
Participate in monthly PTRT (Product Technical Review Team) and Regulatory Community of Practice meetings.
Provide regulatory updates during monthly Quality Council meetings.
Ensure that all mandatory licenses and registrations are current in compliance with regulatory requirements.
Review QRI reports and assess the impact to the site, taking action as necessary.
Assess vendor change notifications and deviations for regulatory impact.
Assist with regulatory certification and re-certification activities.
Report and resolve cGMP/Regulatory compliance issues as required.

Basic Qualifications:

BS/BA degree.
4+ years of experience in a cGMP environment.

Preferred Qualifications:

2+ years in regulatory affairs, quality, or regulatory compliance roles.
Prior experience with licensed biopharmaceutical or biological products.
Knowledge of GMPs, FDA, MHRA, EMA, and other regulatory agency requirements.
Strong written communication, organizational, and computer skills.
Effective interpersonal skills and the ability to prioritize and implement decisions.
Experience working in multidisciplinary teams, including engineering, operations, validation, production, and QC.

Why GSK?
GSK is a global biopharma company on a mission to unite science, technology, and talent to get ahead of disease. Join us at this exciting time to help improve the health of billions of people worldwide.

Benefits:
GSK offers a comprehensive benefits program, which you can learn more about on the GSK US Benefits Summary page.

Application Instructions:
Please submit your application by January 29, 2025, including your CV or cover letter to demonstrate how your experience aligns with the role's requirements.

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Regulatory Compliance Specialist

Job Description

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