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- Tasks: Lead regulatory CMC activities and prepare briefing packages for biosimilar products.
- Company: Join a growing pharmaceutical business based in London, making waves in the industry.
- Benefits: Enjoy a competitive salary and a comprehensive benefits package.
- Why this job: Be part of a dynamic team impacting healthcare through innovative biosimilars.
- Qualifications: Experience in CMC Regulatory Affairs and a degree in Life Sciences preferred.
- Other info: Engage with top regulatory authorities and contribute to exciting product launches.
The predicted salary is between 43200 - 72000 £ per year.
A growing pharmaceutical business in London is 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 launches.
- Working knowledge of FDA, EMA, ICH and cGMP CMC regulatory guidance and regulations.
- Experience interacting with EU regulatory authorities – Scientific advice meetings/ Pre-submission meetings.
- Degree in Life Sciences would be beneficial.
Salary and benefits:
A highly competitive salary and wider benefits scheme is on offer.
To apply for this position or hear further details then please contact Freddie Hill via Freddie.hill@pharma-partners.co.uk.
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
Make sure to network with professionals in the regulatory affairs field, especially those who have experience with CMC activities. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends in biosimilar regulations.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks of the EMA and other relevant authorities. Understanding their processes and requirements will not only help you in interviews but also demonstrate your commitment to the role.
✨Tip Number 3
Prepare to discuss your previous experiences with MAA submissions and how you've successfully navigated challenges in regulatory affairs. Be ready to provide examples that showcase your problem-solving skills and ability to work under pressure.
✨Tip Number 4
Research the company’s recent projects and any news related to their biosimilar products. This knowledge will allow you to tailor your discussions during interviews and show that you are genuinely interested in contributing to their success.
We think you need these skills to ace Senior Manager, Regulatory Affairs CMC
Some tips for your application 🫡
Understand the Role: Thoroughly read the job description for the Senior Regulatory Affairs Manager CMC position. Make sure you understand the responsibilities and requirements, especially regarding CMC activities and interactions with regulatory authorities.
Tailor Your CV: Highlight your relevant experience in CMC Regulatory Affairs, particularly any work with biosimilars or interactions with EMA and other regulatory bodies. Use specific examples to demonstrate your expertise and achievements in this area.
Craft a Compelling Cover Letter: Write a cover letter that connects your background to the job requirements. Emphasise your experience with regulatory submissions and your ability to support product launches. Show enthusiasm for the role and the company.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or typos. A polished application reflects your attention to detail, which is crucial in regulatory affairs.
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, FDA, and ICH. Being able to discuss recent changes or trends in regulatory affairs will demonstrate your expertise and commitment to the field.
✨Prepare for Technical Questions
Expect questions related to CMC activities and biosimilar product development. Brush up on your knowledge of submission processes and be ready to explain how you've handled similar situations in your previous roles.
✨Showcase Your Communication Skills
As a Senior Manager, you'll need to interact with various stakeholders, including regulatory authorities. Be prepared to discuss how you effectively communicate complex regulatory information to both technical and non-technical audiences.
✨Demonstrate Strategic Thinking
Highlight your experience in preparing regulatory roadmaps and conducting gap analyses. Discuss specific examples where your strategic insights have led to successful product approvals or mitigated regulatory risks.
