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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 knowledge of EU regulatory processes required.
- Other info: Contact Freddie Hill at pharma-partners for more details or to apply.
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:
Career Wallet 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. Attend industry conferences or webinars where you can meet people who work in regulatory affairs, especially those with experience in CMC. This can help you gain insights into the role and potentially get referrals.
✨Tip Number 2
Familiarise yourself with the latest regulatory guidelines from EMA, FDA, and ICH. Being well-versed in current regulations will not only boost your confidence but also demonstrate your commitment to staying updated in the field during interviews.
✨Tip Number 3
Prepare for potential interviews by practising responses to common questions related to CMC regulatory affairs. Focus on your experience with submissions and interactions with regulatory authorities, as these are key aspects of the role.
✨Tip Number 4
Research the company thoroughly before applying. Understand their product portfolio, recent news, and any challenges they may be facing in regulatory affairs. This knowledge will help you tailor your discussions and show genuine interest in the position.
We think you need these skills to ace Senior Manager, Regulatory Affairs CMC
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities and requirements of the Senior Regulatory Affairs Manager CMC position. Tailor your application to highlight relevant experience in CMC regulatory affairs and your familiarity with EMA and other regulatory authorities.
Highlight Relevant Experience: In your CV and cover letter, emphasise your experience in managing submissions for National and European Marketing Authorisation Applications (MAA). Provide specific examples of your work with biosimilars and any interactions you've had with regulatory agencies.
Showcase Your Knowledge: Demonstrate your understanding of FDA, EMA, ICH, and cGMP CMC regulations in your application. Mention any specific projects where you applied this knowledge, as it will show your capability to handle the responsibilities of the role.
Craft a Compelling Cover Letter: Write a tailored cover letter that not only outlines your qualifications but also expresses your enthusiasm for the role and the company. Make sure to address how your skills align with the company's goals and the specific challenges of the position.
How to prepare for a job interview at Career Wallet
✨Know Your Regulatory Framework
Make sure you have a solid understanding of the FDA, EMA, ICH, and cGMP CMC regulations. Brush up on recent changes and how they impact biosimilar products, as this knowledge will be crucial during your interview.
✨Prepare for Scenario-Based Questions
Expect to be asked about specific situations you've encountered in your previous roles. Prepare examples that showcase your problem-solving skills, particularly in dealing with regulatory authorities and managing submissions.
✨Demonstrate 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 bodies and how you can convey complex information clearly to your team and senior management.
✨Showcase Your Strategic Thinking
Highlight your experience in preparing regulatory roadmaps and conducting gap analyses. Be prepared to discuss how you approach project evaluations and what strategies you employ to ensure compliance and successful product launches.
