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- Tasks: Lead global regulatory submissions and ensure high-quality delivery across product lifecycles.
- Company: Ipsen Biopharm Ltd, a global biopharmaceutical company focused on transformative medicines.
- Benefits: Inclusive workplace culture, career growth opportunities, and a chance to make a real impact.
- Why this job: Join a passionate team dedicated to tackling unmet medical needs through innovation.
- Qualifications: 10-15 years in Regulatory Affairs with strong leadership and project management skills.
- Other info: Dynamic environment with a commitment to diversity and inclusion.
The predicted salary is between 43200 - 72000 £ 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.
Job Description:
The head of Regulatory Submission Project Management provides strategic and operational leadership for a unified Regulatory Project Management (Reg PM) organization overseeing both early-phase (IND and CTR) and late-phase (NDA/MAA/BLA) regulatory submissions globally. This role is accountable for establishing and leading a single, high-performing Regulatory Project Management group that ensures consistent, high-quality, and on-time delivery of regulatory submissions across the full product lifecycle. He/she partners closely with Global Regulatory Affairs, Clinical Development, Biometry, Portfolio Project Management, Pharmaceutical Development and other cross-functional stakeholders to drive submission excellence, risk mitigation, and continuous process improvement.
Main Responsibilities & Technical Competencies
- Strategic Leadership & Governance: Establish, own and lead a single Regulatory Project Management function covering early development (INDs, CTRs, amendments, maintenance) and late-stage submissions (NDA, MAA, BLA, major variations and extensions). Define and implement a global regulatory submission project management strategy, aligned with Global Regulatory Affairs and RegOps objectives.
- Submission Oversight (Early & Late Phase): Provide oversight and/or direct leadership for high-priority, complex, or high-risk submissions, including INDs, NDAs, MAAs, BLAs, and major lifecycle filings. Ensure robust submission planning, scenario planning, and risk/opportunity management across all development stages.
- Operational Excellence & Delivery: Ensure consistent execution of submission activities, including original applications and major variations. Oversee coordination of document authoring, review cycles, publishing readiness, and final submission delivery in collaboration with Publishing Leads.
- People & Team Leadership: Build, lead and develop a Regulatory Project Management organization, including hiring, onboarding, performance management, succession and capability building. Coach and mentor Regulatory Project Managers across experience levels, fostering a culture of accountability, collaboration, and continuous improvement.
- Process, Tools & Continuous Improvement: Act as the global champion for regulatory project management methodologies, tools, and best practices. Standardize and optimize processes for submission planning, tracking, risk management, and reporting.
- Cross-Functional & External Collaboration: Foster strong matrix collaboration across Regulatory Affairs, Clinical Development, PharmDev, Safety, Quality, and external partners. Influence without authority to align stakeholders around submission priorities, trade-offs, and decisions.
HOW - Behavioural Competencies Required
- Manage Complexity (Thinking Dexterity)
- Influences (Being Intentional)
- Communicates Effectively (Being Intentional)
- Ensures Accountability (Making a Real Impact)
- Excellence in Execution (Making a Real Impact)
HOW - Knowledge & Experience
- Significant experience in the pharmaceutical or biotechnology industry.
- Minimum 10–15 years of experience in Regulatory Affairs/Pharmaceutical Project Management, including extensive regulatory submission and project management experience.
- Strong portfolio/program PM capability (critical path, scenario planning, dependency management, risk-based decision support).
- Proven leadership experience managing teams and complex programs in a global, matrixed environment.
- Strong experience leading international IND, CTR, NDA, MAA, and/or BLA submissions.
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.
Head of Regulatory Submission Project Management in Holmfirth employer: Ipsen Pharma (SAS)
Contact Detail:
Ipsen Pharma (SAS) Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Head of Regulatory Submission Project Management in Holmfirth
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Ipsen. A friendly chat can open doors that applications alone can't.
✨Tip Number 2
Prepare for interviews by knowing your stuff. Research Ipsen's projects and values, and think about how your experience aligns with their mission. Show them you’re not just another candidate!
✨Tip Number 3
Practice your storytelling skills. Be ready to share specific examples of your past successes in regulatory project management. Make it engaging and relevant to the role you're after.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen. Plus, it shows you’re serious about joining the Ipsen team.
We think you need these skills to ace Head of Regulatory Submission Project Management in Holmfirth
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Head of Regulatory Submission Project Management role. Highlight your relevant experience in regulatory affairs and project management, especially with INDs, NDAs, and MAAs. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to tell us why you're passionate about regulatory submissions and how your leadership experience can drive submission excellence at Ipsen. Keep it engaging and relevant to the job description.
Showcase Your Achievements: Don’t just list your responsibilities; showcase your achievements! Use specific examples of how you've successfully managed complex submissions or led teams to success. Numbers and outcomes speak volumes, so let us know the impact you’ve made.
Apply Through Our Website: We encourage you to apply through our website for a smoother application process. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, you’ll find all the details you need right there!
How to prepare for a job interview at Ipsen Pharma (SAS)
✨Know Your Regulatory Submissions
Make sure you brush up on the different types of regulatory submissions like INDs, NDAs, and MAAs. Understanding the nuances of each will help you speak confidently about your experience and how it aligns with the role.
✨Showcase Your Leadership Skills
This position requires strong leadership in a matrixed environment. Be ready to share specific examples of how you've successfully led teams through complex projects, especially in regulatory affairs. Highlight your ability to influence without authority.
✨Prepare for Scenario Questions
Expect questions that assess your problem-solving skills in complex situations. Think of scenarios where you had to manage risks or make critical decisions under pressure. Use the STAR method (Situation, Task, Action, Result) to structure your answers.
✨Communicate Clearly and Effectively
Practice delivering concise and structured messages. This role demands clear communication, especially when dealing with stakeholders. Prepare to discuss how you’ve effectively communicated project statuses and influenced decisions in previous roles.
