Compliance Specialist II
PARC Street Partners
Regulatory Manager – CMC Mature Products
GSK
full-time
Posted on:
Location Type: Hybrid
Location: Massachusetts, Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Responsible for the global CMC regulatory activities for assigned projects and responds readily to changing events and priorities.
- Responsible for CMC strategy development, with managerial support, for CMC submission documents to support marketed product lifecycle management activities in accordance with the applicable regulatory & scientific standards.
- Understands, interprets and will sometimes advise teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, review and approval of global CMC applications.
- Ensures all appropriate CMC regulatory aspects for product release are in place, to ensure continuity of market supply.
- Ensures information submitted lifecycle maintenance submissions meets regional requirements, allowing maximum Supply/Production/Quality flexibility with minimal unanticipated questions.
- Works in cross-functional matrix project teams, which include colleagues from regulatory, development, quality and manufacturing ensuring adequate interaction and partnership in order to define proper regulatory CMC filing strategy.
- Maintains high quality standards and seeks to raise levels of performance through continuous improvement and an innovative approach in responding to the evolving regulatory environment.
- Ensures regulatory compliance is maintained and shares best-practices and learnings within the CMC Regulatory teams and other impacted functions.
- Engages in CMC Subject Matter Expert activities internally (for increased compliance, harmonisation and efficiency).
- Will sometimes deliver CMC regulatory strategy to support major inspections (eg PAIs) with managerial support.
Requirements
- Bachelor’s degree in life sciences related discipline
- 3+ years of experience in Chemistry, Manufacturing and Controls (CMC) regulatory affairs or product development experience with involvement in regulatory submission preparation in late phase development and/or marketed product life cycle submissions
- Experience with drug development, manufacturing processes and supply chain
- Experience with worldwide CMC regulatory requirements
- Master’s degree in life sciences, related discipline preferred
- Good time management skills with the ability to effectively plan, prioritise and co-ordinate multiple tasks and adjust to changing priorities to deliver results to tight deadlines
- Continued professional growth in global regulatory affairs including communication of evolving/emerging trends and policies
- Experience in influencing and negotiating with company personnel and with regulatory agencies in a variety of settings
- Strong interpersonal, presentation and communication skills with established internal networks
- Proactively seeks out and recommends process improvements
- Proven ability to develop and implement regulatory strategies and evaluate their potential impact on overall project/product strategy
- Demonstrated ability to handle global CMC issues through continuous change and improvement
- Developing experience in major post approval filing activities (significant manufacturing change or key regulatory interactions in lifecycle management)
- Regulatory Affairs Certification (RAPS)
Benefits
- Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
ChemistryManufacturingControls (CMC)regulatory submission preparationdrug developmentmanufacturing processessupply chainglobal CMC regulatory requirementsregulatory strategiespost approval filing activities
Soft skills
time managementplanningprioritizationcoordinationcommunicationinterpersonal skillspresentation skillsnegotiationprocess improvementadaptability
Certifications
Regulatory Affairs Certification (RAPS)
