At a Glance
- Tasks: Provide regulatory expertise and lead innovative projects in biopharmaceuticals.
- Company: Join Ipsen, a global leader in transformative medicines with a collaborative culture.
- Benefits: Enjoy competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic environment with a commitment to inclusion and personal growth.
- Why this job: Make a real impact on patients' lives while working with passionate teams worldwide.
- Qualifications: Experience in Regulatory Affairs and strong communication skills are essential.
The predicted salary is between 51750 - 63250 £ 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 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 execute 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.
- Lead operational excellence initiatives within GRA.
WHAT - Main Responsibilities & Technical Competencies
- Overall Accountability - Accountable for the 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 execution of the regulatory strategies for all assigned programs, either directly or through the supervision of the Regulatory Asset Team Member:
- Implements regulatory strategy for specific projects under supervision of Therapeutic Area Senior Manager/Director/Senior Director.
- Contributes to the drafting of the regulatory strategy (Global Regulatory Strategy Document).
- Contributes to the data collection supporting building of the regulatory strategy (competitive and regulatory intelligence).
- Gathers, evaluates, organizes, manages and collates information for regulatory dossiers relating to development activities e.g. INDs/clinical trial applications, orphan drug designations, PIP/PSP submissions, NDA/MAA e.g. new and extension/variation etc.
- Contributes to review of regulatory dossiers.
- Ensures quality authoring of core administrative parts of submissions.
- Ensures adequate planning.
- Coordinates with Global Regulatory Affairs publishing team to ensure appropriate planning, completion of submission request forms, binder creation, publishing and submission (where relevant).
- Ensures that regulatory data are adequately reported and QC'd in the relevant tools/databases through data entry team in a timely fashion (e.g. Vreg) and that regulatory documentations are tracked/archived in dedicated tools/databases (e.g. eTMF).
- Uses a variety of specialist computer applications effectively.
- Ensures that quality and regulatory standards are met.
- Operational excellence - Supports operational excellence initiatives and diverse transversal projects within GRA.
- Compliance - Operates according to Regulatory and Ipsen SOPs.
- Reporting - Ensures adequate reporting of his/her activities and participates to various meetings.
- Ethics and Compliance - Accountable for ensuring all activities are conducted in line with Ipsen’s ethics and compliance policies.
HOW - Knowledge & Experience
- Knowledge & Experience (essential):
- First experience in Regulatory Affairs in the pharmaceutical industry or CRO (minimum of 3 years).
- Knowledge of regulatory procedures.
- Excellent written and oral communication skills.
- Strong organizational skills.
- Strong interpersonal skills.
- Curiosity.
- Autonomy.
- Knowledge & Experience (preferred):
- Knowledge of medical device/drug device combination regulations would be a plus.
- Education / Certifications (essential):
- Advanced degree (or equivalent) in scientific discipline (not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
- Language(s) (essential):
- English.
GRA Expert 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 GRA Expert 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 GRA Expert 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.
