Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Lead regulatory CMC activities and prepare briefing packages for biosimilar products.
- Company: Join a dynamic pharmaceutical company in London that's on the rise.
- Benefits: Enjoy competitive pay, flexible working options, and a vibrant team culture.
- Why this job: Make a real impact in the pharmaceutical industry while growing your career.
- Qualifications: Experience in CMC Regulatory Affairs within pharma or biotech is essential.
- Other info: Opportunity to work with top authorities like EMA and Health Canada.
The predicted salary is between 48000 - 72000 £ per year.
A growing pharmaceutical business in London are seeking a Senior Regulatory Affairs Manager CMC to join their team. The role will be responsible for the development, execution and tracking of regulatory CMC activities, specifically the preparation of briefing packages for Scientific Advice of Biosimilar products.
Responsibilities:
- Participate during the interactions with Competent Authorities (EMA, National EU Authorities, Health Canada, TGA and others).
- Address issues/requests by the Agency during MAA.
- Preparation of regulatory roadmaps and gap analysis for the development of biosimilars up to approval.
- Provide support and guidance to the BD&L Team when evaluating new projects and M&A by conducting dossier due diligence.
- Report on regulatory progress and issues for new products or LCM activities at all project team and Project Review Meetings, and to Senior Management as required.
Requirements:
- Experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.
- Relevant and current experience in submissions/managing of National and European MAA and support product.
Senior Manager, Regulatory Affairs CMC employer: Gleeson Recruitment Group
Contact Detail:
Gleeson Recruitment Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager, Regulatory Affairs CMC
✨Tip Number 1
Network with professionals in the pharmaceutical and biotechnology sectors, especially those who have experience in CMC regulatory affairs. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in the field.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for biosimilars in Europe and other relevant markets. Understanding the nuances of these regulations will not only enhance your knowledge but also demonstrate your commitment to the role during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences with MAA submissions and interactions with regulatory authorities. Be ready to share specific examples of how you've successfully navigated challenges in past projects, as this will showcase your expertise and problem-solving skills.
✨Tip Number 4
Stay updated on recent developments in regulatory affairs by following relevant publications and online forums. This will not only keep you informed but also provide you with talking points that can impress interviewers and show your proactive approach to professional growth.
We think you need these skills to ace Senior Manager, Regulatory Affairs CMC
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Senior Regulatory Affairs Manager CMC position. Highlight key responsibilities and requirements that align with your experience, as this will help you tailor your application.
Tailor Your CV: Customise your CV to reflect your relevant experience in CMC Regulatory Affairs. Emphasise your achievements in managing submissions and interactions with regulatory authorities, particularly in the pharmaceutical or biotechnology sectors.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses how your background and skills make you a perfect fit for the role. Mention your experience with biosimilars and any successful projects you've led that relate to the responsibilities outlined in the job description.
Highlight Relevant Skills: In your application, be sure to highlight skills that are crucial for the role, such as regulatory roadmap preparation, gap analysis, and your ability to communicate effectively with Competent Authorities. Use specific examples to demonstrate these skills.
How to prepare for a job interview at Gleeson Recruitment Group
✨Know Your Regulatory Landscape
Familiarise yourself with the latest regulations and guidelines from authorities like EMA, Health Canada, and TGA. Being able to discuss recent changes or trends in regulatory affairs will demonstrate your expertise and commitment to the field.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world situations. Prepare examples of how you've handled regulatory challenges in the past, particularly related to CMC activities and biosimilars.
✨Showcase Your Communication Skills
As a Senior Manager, you'll need to communicate effectively with various stakeholders. Be ready to discuss how you’ve successfully interacted with regulatory agencies and how you convey complex information to non-experts.
✨Demonstrate Strategic Thinking
Highlight your ability to develop regulatory roadmaps and conduct gap analyses. Discuss how you approach long-term planning for product approvals and how you align regulatory strategies with business objectives.
