At a Glance
- Tasks: Lead CMC regulatory strategy for projects from clinical trials to market applications.
- Company: Ipsen Innovation, a leader in biopharmaceuticals with a focus on innovation.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Join a dynamic team with a commitment to career development and impactful work.
- Why this job: Shape the future of healthcare by ensuring compliance and driving innovative projects.
- Qualifications: Experience in CMC regulatory strategy and strong collaboration skills.
The predicted salary is between 70000 - 90000 £ per year.
Responsibility for CMC regulatory strategy for the assigned projects throughout the different phases of development from early clinical trials to initial marketing applications, geographical expansion, and life cycle management.
To manage the CMC Regulatory relationship for their assigned product(s)/projects with Ipsen’s GRA LT, manufacturing sites and/or Ipsen’s External Manufacturing Organisation (EMO) SMEs and LT, Global Regulatory, CMOs and Alliance partner companies to ensure alignment of strategy.
Provide CMC regulatory expertise to R&D & TechOps project teams and lead CMC regulatory interactions for the preparation of submission dossiers and support the development of junior CMC-reg colleagues.
Main Responsibilities & Technical Competencies
- Lead the development of CMC regulatory strategy (overall CMC regulatory roadmaps) for the assigned projects (new products in development and/or commercial product(s) for both lifecycle management and geographical expansion through new MAA registrations) ensuring the CMC reg risks are identified, assessed & shared as appropriate; and verifying the CMC regulatory requirements of the targeted countries are met.
- Work efficiently with CMC regulatory senior management to ensure coherence of strategies across projects.
- Lead the preparation of the CMC part of the dossier by collaborating closely with Pharmaceutical Development and / or Technical Operations teams, to generate effective CMC regulatory dossiers as per the project timelines.
- Work closely with Global Regulatory Affairs Therapeutic Area leads to integrate the CMC regulatory strategy to the overall regulatory strategy of all assigned projects.
- Define and execute the CMC regulatory strategy roadmaps for all products in scope (R&D and LCM) ensuring that regulatory requirements are met.
- Ensure regional regulatory specificities and needs are incorporated into the global plans including emerging regulations.
- Participate in gap/risk analysis activities as needed, prioritising and planning associated regulatory strategies to address any identified gaps/risks.
- Anticipate any gaps for planned regulatory submissions.
Senior Manager, CMC Regulatory Strategy in London employer: Ipsen
Ipsen Innovation is an exceptional employer that fosters a collaborative and innovative work culture, particularly for professionals in the CMC regulatory field. With a strong commitment to employee development, we offer numerous growth opportunities and support for continuous learning, ensuring that our team members thrive in their careers. Located in a vibrant environment, Ipsen provides a unique advantage by being at the forefront of pharmaceutical advancements, allowing employees to contribute meaningfully to impactful projects while enjoying a supportive and dynamic workplace.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager, CMC Regulatory Strategy in London
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We think you need these skills to ace Senior Manager, CMC Regulatory Strategy in London
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Ipsen!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Ipsen that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Ipsen!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Ipsen, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Ipsen
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Ipsen that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Ipsen’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
