Posted in Science 30+ days ago.
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Location: King of Prussia, Pennsylvania
Position Title: CMC Regulatory Project Manager
Working Location: Pennsylvania
Employment Status: Full time
Required Experience: Not Indicated
Required Education: Bachelors
Travel Required: 0%
Global CMC Regulatory Affairs:
Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and Global Manufacturing and Supply to enable approval of new medicines and uninterrupted supply of our medicines to patients. Our work spans all formulation types, novel technologies, and Advanced Manufacturing Technology for multiple modalities for small and large molecules through to Cell and Gene Therapy.
The Regulatory Project Manager will support key, strategic CMC regulatory activities for investigational and/or commercial biopharmaceutical (therapeutic protein and cell & gene therapy) products.
The successful candidate will:.
• Represent Biopharmaceutical CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to product development teams, Global Manufacturing and Supply (GMS), Clinical Trial Supply, and Quality Assurance among other functions.
• Understand and advise on regulations, guidelines, procedures, and policies relating to the development, registration and manufacture of biopharmaceutical products to expedite submission, review, and approval of high quality, global CMC applications.
• Be responsible for the global CMC regulatory activities for project teams by ensuring that CMC dossier components of clinical trial applications and marketing applications meet global standards for content, quality, and regulatory requirements.
• Identify, document, and communicate regulatory project risks that could impact the timeline and quality of regulatory submissions.
• Support license maintenance, change control requests, and post-approval submissions while ensuring delivery to agreed timelines.
• Manage multiple projects and teams simultaneously.
• Maintain high quality standards and a continuous improvement and innovative approach in responding to the evolving regulatory environment while contributing to the improvement of GSK’s CMC regulatory processes, policies, and systems.
• Communicate across the company to influence CMC project and policy issues that are aligned with business needs.
This role would suit a self-motivated individual who can demonstrate initiative, high learning agility and adaptability. You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset.
The role would also suit an individual who has experience of working in a cross-functional, global supply organization. During the application process, we are looking to see that applicants have a clear understanding of the complexities and importance of supporting production within a pharmaceutical manufacturing process.
This role can be based in Upper Merion, Pennsylvania, USA or Ware, Hertfordshire, UK. This role requires you to interact across all the functions of Global Regulatory Affairs to ensure global approaches and strong connectivity.
• Bachelor’s degree in life sciences or related scientific discipline.
• CMC regulatory Affairs or CMC development experience in pharmaceutical or biotechnology drug development, with direct involvement in CMC-related functions and/or regulatory submission preparation.
• Detailed knowledge of biopharmaceutical drug development and manufacturing/supply processes.
• Basic knowledge of FDA and EU CMC regulatory requirements
We are an Equal Opportunity Employer and do not discriminate against
any employee or applicant for employment because of race, color, sex,
age, national origin, religion, sexual orientation, gender identity,
status as a veteran, and basis of disability or any other federal,
state or local protected class.