At a Glance
- Tasks: Lead global labelling strategy and ensure compliance with regulatory requirements.
- Company: Ipsen Biopharm Ltd, a global biopharmaceutical company focused on transformative medicines.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Join a diverse team committed to collaboration and excellence.
- Why this job: Make a real impact in healthcare by shaping labelling strategies for innovative products.
- Qualifications: Advanced degree in life sciences and strong regulatory affairs experience required.
The predicted salary is between 75000 - 100000 £ per year.
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 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:
Summary & Purpose of the Position
- Responsible for leading the development and implementation of global labelling strategy for assigned products, including those in early and late-stage development, life cycle management (LCM), and marketed portfolios.
- Play an active role in shaping labelling strategy early in product development by providing regulatory input into clinical development plans.
- Ensure that core labelling (e.g., Company Core Data Sheets) and major market labelling comply with global regulatory requirements, reflect current scientific and clinical evidence, and support the safe and effective use of Ipsen products.
- Accountable for the quality and consistency of labelling content across global markets.
- Play a key role in driving transformation, process excellence, and capability building across Global Labelling.
Main Responsibilities & Technical Competencies
- Drive the development of global labelling strategies in alignment with the overall asset strategy and processes.
- Contribute to early development programs by identifying labeling-relevant clinical endpoints.
- Develop and maintain core labelling documents and major market labels.
- Accountable for proposing and driving labelling positions, leading cross-functional alignment.
- Support regulatory agency interactions and negotiations involving labeling content.
Continuous improvement and team’s capabilities
- Provide input and may lead the improvement of global labeling processes, templates, tools and systems.
- Ensure right communication with stakeholders and in particular with compliance for the implementation of safety label changes.
- Responsible for promoting labelling activities and processes across Ipsen organization.
Behavioural Competencies Required
- Define and drive a clear global labelling strategy aligned with asset development and lifecycle objectives.
- Integrate complex and sometimes conflicting inputs into robust labelling decisions.
- Drive alignment and decision-making across cross-functional and matrix teams.
- Build strong partnerships across Global, Regional, and Local Regulatory teams.
- Engage, guide, and develop team members and stakeholders to deliver high-quality labelling outcomes.
Knowledge & Experience (essential)
- Strong knowledge of global regulatory labelling requirements (FDA, EMA, ICH).
- Demonstrated expertise in the development and maintenance of core labelling.
- Proven ability to define and implement global labelling strategies.
- Strong scientific and analytical capability to interpret complex data.
- Proven ability to operate effectively in matrix environments.
Education / Certifications (essential)
- Advanced degree in life sciences, pharmacy, medicine or related field.
- Significant experience in regulatory affairs within the pharmaceutical or biotechnology industry.
Language(s) (essential): Fluent English
Director, Regulatory Affairs, Labelling in London employer: Ipsen Group
Ipsen Group in Wrexham is an excellent employer that prioritises employee growth and development within the pharmaceutical manufacturing sector. With a strong commitment to innovation and excellence, employees benefit from a collaborative work culture that values safety and compliance, alongside opportunities for meaningful contributions to drug substance production. The location offers a supportive environment where team members can thrive and make a real impact in their roles.
