Regulatory Submission Project Manager

Title:

Regulatory Submission Project Manager

Company:

Ipsen Biopharm Ltd

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 endeavor 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!

For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram.

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

#LI-MM1 #LI-hybrid

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.