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- Tasks: Lead regulatory CMC activities and prepare briefing packages for biosimilar products.
- Company: Join a growing pharmaceutical business 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 with innovative biosimilar solutions.
- Qualifications: Experience in CMC Regulatory Affairs and knowledge of EU regulatory processes required.
- Other info: Contact Freddie Hill at pharma-partners for more details.
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.
- A 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.
Senior Manager, Regulatory Affairs CMC (Cambridge) 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 (Cambridge)
✨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 conversations during interviews and show that you're genuinely interested in contributing to their success.
We think you need these skills to ace Senior Manager, Regulatory Affairs CMC (Cambridge)
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in CMC Regulatory Affairs, particularly within the pharmaceutical or biotechnology industry. Emphasise any relevant submissions or interactions with regulatory authorities like EMA and Health Canada.
Craft a Compelling Cover Letter: In your cover letter, address how your background aligns with the responsibilities of the role. Mention specific experiences that demonstrate your ability to prepare regulatory roadmaps and conduct due diligence for new projects.
Showcase Relevant Skills: Highlight your working knowledge of FDA, EMA, ICH, and cGMP regulations. Provide examples of how you've successfully navigated regulatory challenges in past roles, especially during MAA submissions.
Follow Up: After submitting your application through our website, consider sending a polite follow-up email to express your continued interest in the position. This can help keep you on the radar of the hiring team.
How to prepare for a job interview at Gleeson Recruitment Group
✨Know Your Regulatory Landscape
Familiarise yourself with the latest regulations and guidelines from EMA, FDA, and ICH. Being able to discuss recent changes or trends in regulatory affairs will demonstrate your expertise and commitment to staying updated.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Think of examples from your past experience where you successfully navigated regulatory challenges, particularly in CMC activities.
✨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've effectively communicated complex regulatory information to different audiences.
✨Demonstrate Strategic Thinking
Highlight your ability to develop regulatory roadmaps and conduct gap analyses. Discuss how you've contributed to the strategic direction of projects, especially in relation to biosimilars and product launches.
