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For Companies At a Glance
- Tasks: Lead regulatory support for established pharmaceutical products and manage submissions.
- Company: Join a dynamic pharmaceutical business based in London, focused on innovation.
- Benefits: Enjoy a competitive salary and a comprehensive benefits package.
- Why this job: Be part of a collaborative team making a real impact in the pharmaceutical industry.
- Qualifications: Experience in CMC Regulatory and a degree in Life Sciences preferred.
- Other info: Opportunity to work with EU regulatory authorities and contribute to exciting projects.
The predicted salary is between 43200 - 72000 £ per year.
Job Description
Job title: Senior Manager, Regulatory CMC
A pharmaceutical business in London are seeking a Senior Manager, Regulatory CMC to join their team. The role will be responsible for providing CMC regulatory support for established products including growth market submissions and any post-approval activities relevant.
Responsibilities:
- Collaborate with IPT and CMC teams supporting development projects towards license submission and approval.
- Preparation of regulatory roadmaps and gap analysis for the development of biosimilars up to approval.
- Provide CMC expertise cross functionally.
- 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 within the pharmaceutical or biotechnology industry
- Experience with Small Molecules is a must have and any experience in Biologics would be a bonus.
- 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
Senior Manager, Regulatory 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 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 CMC regulatory roles. This can help you gain insights into the company culture and potentially get a referral.
✨Tip Number 2
Stay updated on the latest regulatory guidelines and trends in CMC for both small molecules and biologics. This knowledge will not only prepare you for interviews but also demonstrate your commitment to the field.
✨Tip Number 3
Prepare to discuss specific examples of your experience with EU regulatory authorities. Be ready to share how you've successfully navigated scientific advice meetings or pre-submission meetings, as this will showcase your expertise.
✨Tip Number 4
Research the company’s recent projects and any news related to their products. Being knowledgeable about their portfolio will allow you to tailor your discussions and show genuine interest during interviews.
We think you need these skills to ace Senior Manager, Regulatory CMC
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in CMC regulatory within the pharmaceutical or biotechnology industry. Emphasise your work with small molecules and any relevant experience with biologics.
Craft a Compelling Cover Letter: Write a cover letter that specifically addresses the responsibilities mentioned in the job description. Discuss your experience with regulatory roadmaps, gap analysis, and interactions with EU regulatory authorities.
Showcase Relevant Achievements: In your application, include specific examples of past projects where you provided CMC expertise or reported on regulatory progress. This will demonstrate your capability to handle the responsibilities of the role.
Proofread Your Application: Before submitting, carefully proofread your application for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in regulatory roles.
How to prepare for a job interview at Gleeson Recruitment Group
✨Know Your CMC Regulations
Make sure you have a solid understanding of CMC regulations, especially those relevant to small molecules and biologics. Brush up on recent changes in the regulatory landscape, as this will show your commitment and expertise during the interview.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world scenarios. Prepare examples from your past experiences where you successfully navigated regulatory challenges or collaborated with cross-functional teams.
✨Showcase Your Communication Skills
As a Senior Manager, you'll need to communicate effectively with various stakeholders. Be ready to discuss how you've reported on regulatory progress and issues in previous roles, and highlight your experience in presenting to senior management.
✨Research the Company and Its Products
Familiarise yourself with the pharmaceutical business's portfolio and any recent developments. This knowledge will not only help you answer questions more effectively but also demonstrate your genuine interest in the role and the company.
