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- Tasks: Lead regulatory strategies for emerging markets and ensure timely submissions across multiple regions.
- Company: Dynamic pharmaceutical company focused on global market impact.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on innovation and improvement.
- Why this job: Make a real difference in global health by shaping regulatory strategies.
- Qualifications: 3-5 years in pharma/biotech with strong regulatory experience.
The predicted salary is between 60000 - 80000 £ per year.
Member of regulatory project team(s) representing the Global Emerging Markets primarily for 1-3 marketed products. Responsible for ensuring availability of contemporary regulatory documentation to support new submission and lifecycle management activities. Provides regulatory support to GEM regional leads including submissions for NCE/NME.
Accountability Description
- Manages the communication, development and implementation of Global Emerging Market strategies for Safety Updates for assigned products across 4 regions (LATAM, CEE, APAC and MENA). Working closely with Regional Regulatory Leads.
- Accountable and responsible for delivery of regulatory strategy for assigned products in CEER and MENA regions, working closely with partner and affiliate counterparts, supply chain, commercial and medical colleagues where required to determine optimal strategy to ensure supply continuity and patient safety. Ensuring delivery of agreed strategy to the timelines agreed.
- Provides regulatory support for NCE/NME submissions in assigned regions/markets (CEER and MENA), developing and agreeing submission strategy and timelines, liaising closely with external CRO to ensure delivery to agreed strategy/timelines.
- Product lead and member of Regulatory Project Team / Asset Team for 1-3 established products, provides consolidated Global Emerging Markets input and insight into the team, to ensure GEM has a “voice” within the organization and to ensure GEM strategy is developed in parallel and in alignment with EU/US strategies.
- Product lead for at least one Development Product from Phase 2, as above provides consolidated Global Emerging Markets input and insight into development teams, to ensure GEM has a “voice” within the organization and to ensure GEM strategy is developed in parallel and in alignment with EU/US strategies. Working closely with GEM regional leads, drives the development of Regulatory strategy in the regions, responsible for gaining agreement for submission timelines in the markets with the ASSET team and ensuring submissions are made to the timelines agreed, working through GEM regional colleagues.
- Managing day-to-day issues which arise as a result of misunderstanding in systems and processes, firefighting issues which arise due to market issues and asset-driven issues with supply chain. Taking time to review root cause and proposing/looking for improvements to our current systems and processes, to improve our performance and consolidate GEM within the global organisation.
Qualifications
- Minimum 3-5+ years pharmaceutical/biotechnology industry experience in International/Regulatory Emerging Markets.
- Skills and experience to represent the GEM group on project teams.
- Experience and knowledge in the preparation of major regulatory submissions.
Our new Senior Manager will be responsible for driving development and implementation of Global Emerging Market (GEM) regulatory strategies for legacy registration submissions and lifecycle management activities across four regions (LATAM, ASIA, CEE, MENA).
Senior Manager – Global Emerging Markets GSRS in Maidenhead employer: Biogen SANDBOX
Contact Detail:
Biogen SANDBOX Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Manager – Global Emerging Markets GSRS in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to professionals in the regulatory field, especially those working in Global Emerging Markets. Use platforms like LinkedIn to connect and engage with them; you never know who might have the inside scoop on job openings.
✨Tip Number 2
Prepare for interviews by researching the company’s recent projects and their impact on GEM strategies. Show that you’re not just interested in the role but also in how you can contribute to their goals across LATAM, CEE, APAC, and MENA.
✨Tip Number 3
Practice your pitch! Be ready to explain how your experience aligns with the responsibilities of managing regulatory strategies and submissions. Highlight your ability to work collaboratively with regional leads and cross-functional teams.
✨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 take the initiative to engage directly with us.
We think you need these skills to ace Senior Manager – Global Emerging Markets GSRS in Maidenhead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV reflects the skills and experiences that match the Senior Manager role. Highlight your experience in regulatory strategies and any specific projects you've led in emerging markets.
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about the role and how your background aligns with our needs. Don’t forget to mention your experience with lifecycle management activities!
Showcase Your Teamwork Skills: Since this role involves working closely with various teams, emphasise your ability to collaborate effectively. Share examples of how you've successfully worked with cross-functional teams in the past.
Apply Through Our Website: We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows you’re keen on joining our team!
How to prepare for a job interview at Biogen SANDBOX
✨Know Your Regulatory Stuff
Make sure you brush up on your knowledge of regulatory frameworks, especially in the LATAM, CEE, APAC, and MENA regions. Familiarise yourself with recent changes and trends in these markets, as this will show that you're not just a candidate but someone who is genuinely interested in the role.
✨Showcase Your Project Management Skills
Be ready to discuss specific examples where you've successfully managed regulatory projects or strategies. Highlight your experience in coordinating with cross-functional teams and how you ensured timely submissions. This will demonstrate your ability to handle the responsibilities outlined in the job description.
✨Communicate Clearly and Confidently
Since you'll be managing communication across various regions, practice articulating your thoughts clearly. Use concise language and avoid jargon unless necessary. This will help you convey your ideas effectively during the interview and show that you can be a strong communicator within the team.
✨Prepare Questions for Them
Interviews are a two-way street! Prepare insightful questions about their current GEM strategies and how they align with global initiatives. This not only shows your interest in the role but also gives you a chance to assess if the company’s values align with yours.