Regulatory Affairs Manager, CMC
1 day ago
We are seeking a highly skilled CMC Regulatory Affairs Manager to join our team at 1925 GlaxoSmithKline LLC. As a key member of our regulatory affairs department, you will be responsible for managing global CMC regulatory activities, from early phase clinical through marketing applications and early lifecycle activities for multiple projects and teams simultaneously.
Key Responsibilities- CMC Strategy Development: Develop and implement CMC regulatory strategies to support the development and registration of new pharmaceutical products.
- Regulatory Document Preparation: Prepare and author technical (CMC) regulatory documents to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards.
- Risk Management: Identify risks to the business associated with submission data and information packages and provide and communicate well-defined risk mitigation strategies.
- Team Leadership: Mentor or train staff, and may have direct line management responsibility for managing project activities for multiple complex projects and teams simultaneously.
- Subject Matter Expertise: Engage and may lead CMC Subject Matter Expert activities and typically has deep/specialized area of expertise, both internally (for increased compliance, harmonization and efficiency) and externally (external advocacy and shaping the regulatory environment).
- Regulatory Strategy: Deliver CMC regulatory strategy to support major inspections (eg PAIs) or quality incidents (PIRCs).
- Submission Content: Has accountability for submission content. Understands, interprets and advises on regulations, guidelines, procedures and policies relating to development, registration and manufacturing of biopharmaceutical products.
- Regulatory Processes: Formulates novel approaches and influences people, evaluating/improving CMC Regulatory processes, policies and systems to enhance the efficiency and quality of departmental work.
- Communication: Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence CMC project and policy issues that are aligned with business needs.
- Education: Bachelor's degree.
- Experience: 6 + years of regulatory affairs experience.
- Skills: Drug development and manufacturing and supply processes, negotiating with regulatory agencies, industry bodies, and internal colleagues in a variety of settings, filing activities (MAA/NDA/BLA, significant manufacturing change or key development interactions at EOP2/prePhase 3 or other regulatory interactions in early development).
We are an equal opportunity employer and welcome applications from diverse candidates. Please visit our website to learn more about our comprehensive benefits program.
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