At a Glance
- Tasks: Lead global product labeling strategy and ensure compliance across markets.
- Company: Join Sobi, a company dedicated to improving lives through innovative therapies.
- Benefits: Competitive pay, work/life balance, and opportunities for professional growth.
- Other info: Dynamic role with international collaboration and excellent career advancement opportunities.
- Why this job: Make a real impact on patients with ultra-rare diseases while working in a collaborative environment.
- Qualifications: Degree in a scientific field and 5+ years in Regulatory Affairs required.
The predicted salary is between 70000 - 90000 £ per year.
Company Description
At Sobi, each person brings their unique talents to work as a team and make a difference.
We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease.
Our edge comes from our team of people and our commitment to patients.
Benefits
- Competitive compensation for your work
- Emphasis on work/life balance
- Collaborative and team-oriented environment
- Opportunities for professional growth
- Diversity and Inclusion
- Making a positive impact to help ultra-rare disease patients who are in need of life‑saving treatments
Job Description
The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA).
This role can be located in several countries in Europe and Switzerland, depending where the chosen candidate will be located.
The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross‑functional stakeholders.
As a core member of the Global Regulatory Team(s) (GRT) for assigned product(s), the GLL ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets.
- Lead the content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI).
- Manage the review and approval of country labeling for new filings in international markets.
- Ensure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives.
- Support continuous improvement of labeling processes and systems.
Key Responsibilities
- Lead the development, implementation, and maintenance of the CCDS, USPI, and EU PI for assigned Sobi products throughout the product lifecycle via cross‑functional Labeling Working Groups (LWG).
- Guide LWGs in labeling discussions with HAs, ensuring management alignment and adherence to labeling governance.
Collaborate closely with internal stakeholders and partner companies, as applicable.
Document and archive LWG decisions and outcomes.
- Present new labeling content and major updates to the Executive Labeling Committee for approval.
- Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US.
- Maintain oversight of labeling compliance, including documentation of labeling content deviations and end‑to‑end tracking of safety variations.
- Contribute to the development and improvement of labeling processes, including creation and review of process documents.
- Support inspections and audits related to labeling activities.
- Participate in cross‑functional and cross‑regional initiatives to strengthen collaboration and increase operational efficiencies.
Qualifications
- Degree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific discipline such as Pharmacy, Medicine, Life or Natural Sciences.
- At least 5 years of experience in Regulatory Affairs within the pharmaceutical industry or a regulatory authority, including at least 3 years of relevant experience in prescription drug labeling.
- Experience working with different types of labeling documents, including (Development) Core Data Sheets, EU and/or US Prescribing Information, and Target Product Labels, for both marketed and investigational products.
- Experience leading project teams in a cross‑functional matrix environment.
- Comfortable working in a global, cross‑functional environment, collaborating effectively with stakeholders across multiple regions, time zones, and cultural backgrounds.
- Experience with Regulatory Information Management systems.
- Strong proficiency with standard business tools (e. g., MS‑Office).
- Excellent English language skills (oral/written/listening); additional languages are an advantage.
- Ability to plan, coordinate and lead multiple projects concurrently.
- Desired
- Knowledge of labeling requirements and templates in geographic regions outside of the US and EU.
- Experience in aligned drug and device processes related to Instructions for Use (IFU) management.
- #J-18808-Ljbffr
Global Labelling Lead in London employer: Sobi - Swedish Orphan Biovitrum AB (publ)
At Sobi, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. Our commitment to employee growth is evident through continuous professional development opportunities and a supportive environment that encourages cross-functional teamwork. Located in a vibrant setting, we offer competitive benefits and the chance to make a meaningful impact in the field of biopharmaceuticals, ensuring that our employees feel valued and engaged in their work.
Contact Details:
Sobi - Swedish Orphan Biovitrum AB (publ) Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Global Labelling Lead in London
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like Sobi - Swedish Orphan Biovitrum AB (publ). 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 Sobi - Swedish Orphan Biovitrum AB (publ).
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Sobi - Swedish Orphan Biovitrum AB (publ). 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 Sobi - Swedish Orphan Biovitrum AB (publ) is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Global Labelling Lead 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 Sobi - Swedish Orphan Biovitrum AB (publ)!
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 Sobi - Swedish Orphan Biovitrum AB (publ) 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 Sobi - Swedish Orphan Biovitrum AB (publ)!
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 Sobi - Swedish Orphan Biovitrum AB (publ), 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 Sobi - Swedish Orphan Biovitrum AB (publ)
✨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 Sobi - Swedish Orphan Biovitrum AB (publ) 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 Sobi - Swedish Orphan Biovitrum AB (publ)’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.
