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- Tasks: Lead regulatory strategies for innovative biopharmaceutical products and ensure compliance across global markets.
- Company: Join Ipsen, a dynamic biopharmaceutical company focused on transformative medicines.
- Benefits: Enjoy competitive salary, health benefits, and opportunities for professional growth.
- Why this job: Make a real impact on patients' lives while working in a collaborative environment.
- Qualifications: Experience in drug development and strong communication skills are essential.
- Other info: Be part of a passionate team dedicated to tackling high unmet medical needs.
The predicted salary is between 36000 - 60000 £ 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:
WHAT - Summary & Purpose of the Position
- To be accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide.
- To provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects.
- Act as the interface between the R&D/Franchise/Operations and GRA on all regulatory issues relevant to Development and Product Maintenance activities within the assigned product/project.
- To ensure the development and flawless execution of regulatory strategies for the assigned products/projects and all of its components (both development and marketed products) for assigned region or worldwide.
- Responsible for having a broad perspective on external influencing issues as he/she may participate in external influencing activities with health authorities or trade associations, particularly those that would benefit from a broad perspective on Ipsen regulatory policy.
- Lead operational excellence initiatives within GRA.
WHAT - Main Responsibilities & Technical Competencies
- Overall Accountability: Accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or worldwide, working with R&D, Franchise, Operations and within the regulatory science community to bring innovative and compliant approaches to the development and maintenance of those products.
- Product/Project Leadership: Accountable for the development and continuous adaptation of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member.
- Provide regulatory input into target product profile (target indications, therapeutic positioning, and key differentiating characteristics).
- Provide regulatory input into the Integrated Asset Strategic Plan. In collaboration with other departments, define the optimal plan to reach the target product profile, taking into consideration the most favourable timing for all key markets.
- Continuously evaluate the global match between development objectives and current plan versus new key findings and regulatory requirements. In collaboration with relevant functions and Asset Team/Sub-teams, ensure plan adaptation when needed. Assess impact on timelines and/or label; propose remediation where possible.
- With Asset Team/Sub-teams, define appropriate strategy in terms of sequencing of indications, dosage forms and geographies. Establish optimal label with appropriate balance between commercial expectations, regulatory requirements, and development outcomes.
- Identify opportunities and limiting factors for optimal label and propose alternative solutions.
- Incorporate commercialization challenges into regulatory strategy (not limited to trademarks, licensing agreements, product sourcing, legal status, distribution channels). Carry strategy beyond Marketing Authorization, to incorporate Pricing & Reimbursement considerations, in collaboration with Health Outcomes and Pharmacoeconomics.
- Responsible for Regulatory Intelligence for relevant disease area and to identify and then communicate the implication of upcoming trends that may impact the business.
- In collaboration with other functions ensure the establishment of CCDS and required safety plans for the assigned product.
- Ensure regional regulatory specificities and needs are incorporated into the global plans through collaboration with local and intercontinental RA where available.
- Define and execute strategy for regulatory consultation (e.g. Scientific Advice, FDA planned meetings, regulatory boards).
- Lead the preparation of submissions including PIPs, scientific advices, orphan drug designation submissions.
- Advocate to and seek buy-in from senior leaders in Ipsen and Health Authorities to proposed strategies.
- Responsible for ensuring potential risks have been identified and mitigation options proactively proposed for project team and senior management decision making.
- Accountable for the flawless execution and implementation of the related Global Regulatory plans and activities with internal or external resources as appropriate and by using Ipsen tools and processes.
- Build effective relationships with global regulators for professional communications on Ipsen strategy in relation to assigned products/disease areas.
- Responsible for ensuring outsourced activities are delivered on time and on budget.
- Responsible for identifying and alerting management regarding any service issues.
- Review and input to all key documentation relevant to Franchise plans as required.
- Responsible for conducting regulatory due diligence assessment on external opportunities.
- Lead operational excellence initiatives within GRA.
- Contribute towards effective planning of the GRA budget.
Key technical competencies:
- Excellent written and oral communication skills and delivers all communication with clarity and impact.
- Ability to distil key information from complex and extensive sources and present the information in a constructive way.
- Solid project management skills with proven ability to develop and implement longer term plans or delivery of large-scale projects.
- Consistent ability to foster strong matrix working.
- Strong interpersonal and negotiation skills with a proven ability to build strong personal networks, both within and outside Ipsen.
- Proven capability to influence decision makers both internally and externally.
- Strategic thinking with a proven ability to derive creative solutions to regulatory problems, while balancing the expectations of Agencies and ensuring compliance with regulation in all regions.
- Shows a constant focus on improving performance and excellence in all tasks.
- Capable of seeing opportunities and revising process or approach to reduce barriers for others to be able to deliver more.
- Proven ability to lead change and communicate difficult messages effectively.
Ethics and Compliance: Accountable for ensuring all activities are conducted in line with Ipsen's ethics and compliance policies.
HOW - Behavioural Competencies Required:
- Excellence in Execution
- Ensures Accountability
- Communicates Effectively
- Influences
- Manage Complexity
HOW - Knowledge & Experience:
- Proven experience of drug development/registration and managing complex worldwide products/projects within a relevant therapeutic area, in key geographies.
Manager, Global Regulatory Affairs in London employer: Ipsen Group
Contact Detail:
Ipsen Group Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Global Regulatory Affairs in London
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their products and recent news. This will help you tailor your answers and show that you're genuinely interested in joining their team.
✨Tip Number 3
Practice your pitch! Be ready to explain why you're the perfect fit for the role. Highlight your relevant experience and how it aligns with the company's goals. Confidence is key!
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets noticed. Plus, we love seeing candidates who are proactive about their job search.
We think you need these skills to ace Manager, Global Regulatory Affairs in London
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter for the Manager, Global Regulatory Affairs role. Highlight your relevant experience in drug development and regulatory strategies, showing us how you can contribute to our mission at Ipsen.
Showcase Your Communication Skills: Since this role requires excellent written and oral communication, use your application to demonstrate these skills. Be clear and concise, and make sure your passion for regulatory affairs shines through!
Highlight Your Project Management Experience: We want to see your solid project management skills! Include examples of how you've successfully managed complex projects in the past, especially in a regulatory context, to show us you're the right fit for the job.
Apply Through Our Website: Don't forget to submit your application through our website! This ensures that we receive all your details correctly and helps us keep track of your application as we review candidates for this exciting opportunity.
How to prepare for a job interview at Ipsen Group
✨Know Your Regulatory Stuff
Make sure you brush up on the latest regulatory guidelines and trends in the biopharmaceutical industry. Being able to discuss recent changes or challenges in global regulatory affairs will show that you're not just knowledgeable but also genuinely interested in the field.
✨Showcase Your Project Management Skills
Prepare examples of how you've successfully managed complex projects in the past. Highlight your ability to develop and implement long-term plans, as well as how you’ve navigated challenges. This will demonstrate your capability to handle the responsibilities of the Manager, Global Regulatory Affairs role.
✨Communicate Clearly and Effectively
Practice articulating your thoughts clearly and concisely. Since the role requires excellent communication skills, be ready to showcase your ability to distil complex information into understandable terms. Consider doing mock interviews to refine your delivery.
✨Build Relationships
Think about how you can demonstrate your interpersonal skills during the interview. Be prepared to discuss how you've built strong networks in previous roles and how you plan to foster relationships with global regulators at Ipsen. This will highlight your collaborative approach and ability to influence decision-makers.
