At a Glance
- Tasks: Lead global teams to manage regulatory submissions and ensure compliance with industry standards.
- Company: Ipsen Biopharm Ltd, a global biopharmaceutical company focused on transformative medicines.
- Benefits: Inclusive workplace culture, opportunities for growth, and a chance to make a real impact.
- Other info: Dynamic environment with a commitment to diversity and inclusion.
- Why this job: Join a passionate team dedicated to improving patient outcomes through innovative solutions.
- Qualifications: Experience in regulatory affairs and project management in the pharmaceutical industry.
The predicted salary is between 63000 - 77000 £ per year.
About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavour every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society!
Job Description: The Regulatory Submission Manager collaborates with regional and global cross-functional teams to plan, coordinate, and deliver high-quality, compliant regulatory submissions, ensuring business objectives and timelines are met. The role is responsible for developing and executing submission project plans for new marketing authorisations, new indications, and other major regulatory submissions supporting product development and registration strategies. Working closely with stakeholders across Regulatory Affairs, Clinical, Quality, Manufacturing, and other functions, the Regulatory Submission Manager manages submission timelines, aids decision making through scenario planning, drives risk mitigation ensuring alignment throughout the project.
Applying project management principles, tools and regulatory expertise, the Regulatory Submission Manager oversees the preparation, compilation, review, and delivery of global regulatory submissions, ensuring compliance with regulatory requirements and internal processes. The role requires a working knowledge of drug development, regulatory filing procedures, and the CTD/eCTD framework, while promoting best practices, continuous improvement, and effective cross-functional collaboration to enhance submission quality and operational efficiency.
- Lead global cross-functional submission teams to plan, coordinate, and deliver regulatory submissions in support of new marketing authorizations, new indications, and other strategic regulatory filings.
- Collaborate with Global Regulatory Affairs and key stakeholders to execute regulatory submission strategies and ensure alignment with global product development and registration objectives.
- Develop, maintain, and manage integrated submission timelines as part of a project plan, identifying interdependencies, resolving conflicts, and mitigating risks to support on-time delivery of submissions across multiple regions.
- Lead submission planning activities, including kick-off meetings, timeline development, scenario planning, and preparation of materials to facilitate team discussions and decision-making in partnership with the Global Regulatory Leads.
- Coordinate the identification of submission risks, development of mitigation and escalation plans, and proactively drive issue resolution to maintain schedule adherence and submission quality.
- Coordinate submission deliverables across functional areas, ensuring document readiness, quality standards, and compliance with internal processes and regulatory requirements.
- Create and maintain submission forecasts aligned with Global Regulatory Strategy Plans to support portfolio planning and strategic decision-making.
- Develop communication plans and provide regular updates to stakeholders on submission status, milestones, risks, and key decisions.
- Champion best practices, lessons learned, and continuous improvement initiatives to enhance submission management processes, operational efficiency, and team effectiveness.
Knowledge & Experience (essential):
- Experience in the pharmaceutical industry, including experience in Regulatory Affairs with a focus on regulatory submission management (project management) experience.
- Strong experience in leading submission processes and CTD filings on an international level.
- A good understanding of drug development, strategy, and managing complex products/projects at international level.
- Strong multi-cultural awareness and sensitivity.
- Excellent organizational & management skills.
- Prior leading role on complex submission or excellence projects with multiple stakeholders.
- Experience with project management tools.
Knowledge & Experience (preferred):
- Experience managing global regulatory submissions across multiple regions (FDA, EMA, and other health authorities).
- Experience working in a global matrix environment and leading cross-functional teams.
- Knowledge of eCTD publishing, RIMS, and regulatory submission technologies.
- Experience driving process improvement and operational excellence initiatives.
Education / Certifications (essential): Degree in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
Education / Certifications (preferred): Project Management Qualification.
Language(s) (essential): Fluent in English.
We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application.
Regulatory Submission Project Manager in London employer: Ipsen
Ipsen Biopharm Ltd is an exceptional employer that prioritises a human-centric workplace culture, fostering collaboration and excellence. With a commitment to employee growth, Ipsen offers opportunities for continuous improvement and innovation in the biopharmaceutical field, particularly in vibrant locations like Paris and London. Employees are empowered to thrive, making a meaningful impact on patients and society while enjoying a supportive environment that values diverse perspectives.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Submission Project Manager in London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Ipsen. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
✨Join Relevant Professional Bodies
Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Ipsen.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Ipsen. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
✨Tailor Your Approach
When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what Ipsen is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Submission Project Manager 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.
✨Showcase Relevant Experience
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.
✨Be Ready for Regulatory Scenarios
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.
