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- Tasks: Lead CMC regulatory activities for GSK's vaccine products and manage complex projects.
- Company: GSK is a global biopharma leader focused on improving health through innovative vaccines and medicines.
- Benefits: Enjoy a dynamic work environment with opportunities for growth, mentorship, and collaboration.
- Why this job: Join a mission-driven team that values innovation and inclusivity in tackling global health challenges.
- Qualifications: Master's or PhD in Life Sciences; extensive CMC regulatory expertise required.
- Other info: Fluency in English and French preferred; strong project management skills essential.
The predicted salary is between 43200 - 72000 £ per year.
Lead CMC regulatory activities in the late development and/or lifecycle management of GSK products.
Responsibilities:
- Drive the CMC strategy, coordinate the timely preparation and authors, as needed, of technical (CMC) regulatory documents to support lifecycle maintenance submissions, in accordance with applicable regulatory & scientific standards, considering evolving regulatory requirements.
- Identify risks to the business associated with submission data and information packages, and communicate well-defined risk mitigation strategies.
- Play a key role in major post-approval filing activities (e.g., significant manufacturing changes or key regulatory interactions in lifecycle management).
- Mentor or train staff, with potential direct line management responsibilities.
- Manage project activities for multiple complex projects and teams, providing strategic direction and understanding departmental constraints within a highly complex organization.
- Engage and potentially lead CMC Subject Matter Expert activities, with deep/specialized expertise, both internally (for compliance, harmonization, efficiency) and externally (advocacy, shaping regulatory environment).
- Support major inspections (e.g., PAIs) or quality incidents (PIRCs) by delivering CMC regulatory strategies.
- Accountable for submission content, advising on regulations, guidelines, procedures, and policies related to development, registration, and manufacturing of biopharmaceutical products to expedite approvals.
- Ensure all CMC regulatory aspects for product release are in place to maintain market supply, and that submissions meet regional requirements, allowing maximum flexibility with minimal questions.
- Innovate and improve CMC regulatory processes, policies, and systems to enhance efficiency and quality.
- Communicate complex regulatory issues across the company and with external agencies to influence project and policy decisions, managing agency interactions confidently.
- Operate independently on most matters, communicating sensitive issues promptly and appropriately.
- Participate in corporate evaluations and provide CMC regulatory support for in-licensing and divestment projects.
About you:
- Master's or PhD in Life Sciences or related field.
- Extensive knowledge of drug development, manufacturing, and supply processes.
- Recognized as a CMC Regulatory expert in a specific area.
- Deep understanding of global CMC regulatory requirements and ability to influence the regulatory environment.
- Proven project management and multi-tasking skills.
- Experience managing multiple projects and teams.
- Ability to lead major post-approval filings and regulatory interactions.
- Fluency in English and French.
Preferred Qualifications & Skills:
- Strong project management and multitasking capabilities.
- Effective influencing and negotiating skills with regulatory agencies and industry bodies.
- Ability to handle complex global CMC issues through change and improvement.
GSK is a global biopharma company dedicated to improving health through vaccines, medicines, and innovative science, focusing on infectious diseases, HIV, respiratory/immunology, and oncology. Our success depends on our people. We strive to be an inspiring, inclusive environment where everyone can thrive, grow, and contribute to our mission.
Senior Manager CMC Vaccines Mature Products employer: Gsk
Contact Detail:
Gsk Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager CMC Vaccines Mature Products
✨Tip Number 1
Network with professionals in the biopharmaceutical industry, especially those who have experience in CMC regulatory roles. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in CMC regulations.
✨Tip Number 2
Familiarise yourself with GSK's recent projects and initiatives in the vaccine sector. Understanding their current focus areas will help you tailor your discussions during interviews and demonstrate your genuine interest in their work.
✨Tip Number 3
Prepare to discuss specific examples of how you've successfully managed complex projects in the past. Highlight your project management skills and your ability to lead teams through challenging regulatory landscapes.
✨Tip Number 4
Brush up on your knowledge of global CMC regulatory requirements and be ready to discuss how you can influence the regulatory environment. This will show that you are not only knowledgeable but also proactive in addressing industry challenges.
We think you need these skills to ace Senior Manager CMC Vaccines Mature Products
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior Manager CMC Vaccines Mature Products position. Make sure you understand the responsibilities and qualifications required, as this will help you tailor your application.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in CMC regulatory activities, project management, and any specific expertise related to drug development and manufacturing processes. Use concrete examples to demonstrate your skills.
Showcase Your Qualifications: Clearly state your educational background, particularly if you hold a Master's or PhD in Life Sciences or a related field. Mention any certifications or recognitions that establish you as a CMC Regulatory expert.
Tailor Your Application: Customise your cover letter to reflect your understanding of GSK's mission and how your skills align with their goals. Mention your fluency in English and French, as this is a preferred qualification for the role.
How to prepare for a job interview at Gsk
✨Showcase Your CMC Expertise
Make sure to highlight your extensive knowledge of CMC regulatory activities and drug development processes. Be prepared to discuss specific examples where you've successfully navigated complex regulatory requirements or led major post-approval filings.
✨Demonstrate Project Management Skills
Since the role involves managing multiple projects and teams, be ready to share your experiences in project management. Discuss how you've effectively coordinated activities, managed timelines, and ensured compliance with regulatory standards in previous roles.
✨Communicate Clearly and Confidently
Effective communication is key in this role. Practice articulating complex regulatory issues in a clear and concise manner. Be prepared to explain how you've influenced project decisions and managed agency interactions in the past.
✨Prepare for Scenario-Based Questions
Expect scenario-based questions that assess your problem-solving abilities and risk mitigation strategies. Think of situations where you've identified risks in submission data and how you communicated those risks to stakeholders, showcasing your strategic thinking.
