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16420en
- Contract
- English
- Associate
- Research & Development
- Bern
- Healthcare & Life Sciences
Skills
Pharma, Biotech, Regulatory Affairs, GMP, Agency Interaction Experience, Clinical
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On behalf of our client, a leading biopharmaceutical company, Swisslinx is seeking a Global Regulatory Affairs Lead for their site in Bern. In this role you will be a member of a GRA GPS Therapeutic Area and contribute to the vision and goals for Global Regulatory Affairs.
Contract Type: Contract
Start Date: ASAP
Location: Bern
Workload: 100%
Duration: 6 months’
Your mission:
Develop and lead global regulatory strategies with a focus on patient outcomes and risk management. Represent GRA in key teams and governance meetings, serving as the primary voice and leading the Global Regulatory Affairs Strategy Team (GRAST) for assigned products. Drive GRAST deliverables by assigning tasks, ensuring alignment, and approving key regulatory documents.
• Build strong relationships as a full-time GRA member, providing sound regulatory input to product portfolio teams (e.g., PST, CDT, SMT).
• Lead product portfolio GRASTs to ensure timely global regulatory submissions, partnering with Regulatory Project Managers for on-time delivery.
• Oversee GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and support GRAST members as needed.
• Review and sign off on CTD clinical/safety documentation for development and registration.
• Collaborate with GRA regions in global health authority interactions and participate in product-related discussions.
• Ensure effective communication between product teams (e.g., PST/CDT) and GRA teams (GRAST/GRA TA), facilitating management updates.
• Utilize GRAST, regulatory intelligence, and analytics to deliver Global Regulatory Strategy Outlines for the portfolio.
Your background:
• Minimum 4-year university degree (or equivalent) in scientific field (e.g., biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine), advanced degree desired (e.g., PhD, MS, MBA).
• Minimum of 10 years biotech/pharmaceutical industry, with 5 years regulatory experience, including 3 years in development.
• Direct agency interaction experience, preferably ICH regions, as well as exposure across multiple ICH health authorities.
• Team leadership experience, preferably 3 years as direct or matrix manager.
• Clinical (or Device/Combination Product) regulatory experience desired.
• Exposure to market access activities is desired.
• Strong scientific and ethical foundation.
• Applies Servant Leadership and Team Player principles to team environment, including leading without authority.
• Developing strategic ability to assess product vision and apply regulatory lens to effectively articulate regulatory assumptions, opportunities, and risks.
• Experience working effectively across cultures, inclusive and seeks out alternative perspectives when assessing potential outcomes.
• Fluent in English (written & verbal).
What’s on Offer:
• A 6-month contract with a leading biopharmaceutical company based in Bern.
• The opportunity to lead impactful global regulatory strategies and collaborate with cross-functional teams on innovative projects.
• A dynamic and inclusive work environment within a globally renowned organization.
If this sounds like you, don’t hesitate to apply here or contact Veronika von Mentzer, Recruiter: veronika.nakev@swisslinx.com.
Contract Type: Contract
Start Date: ASAP
Location: Bern
Workload: 100%
Duration: 6 months’
Your mission:
Develop and lead global regulatory strategies with a focus on patient outcomes and risk management. Represent GRA in key teams and governance meetings, serving as the primary voice and leading the Global Regulatory Affairs Strategy Team (GRAST) for assigned products. Drive GRAST deliverables by assigning tasks, ensuring alignment, and approving key regulatory documents.
• Build strong relationships as a full-time GRA member, providing sound regulatory input to product portfolio teams (e.g., PST, CDT, SMT).
• Lead product portfolio GRASTs to ensure timely global regulatory submissions, partnering with Regulatory Project Managers for on-time delivery.
• Oversee GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and support GRAST members as needed.
• Review and sign off on CTD clinical/safety documentation for development and registration.
• Collaborate with GRA regions in global health authority interactions and participate in product-related discussions.
• Ensure effective communication between product teams (e.g., PST/CDT) and GRA teams (GRAST/GRA TA), facilitating management updates.
• Utilize GRAST, regulatory intelligence, and analytics to deliver Global Regulatory Strategy Outlines for the portfolio.
Your background:
• Minimum 4-year university degree (or equivalent) in scientific field (e.g., biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine), advanced degree desired (e.g., PhD, MS, MBA).
• Minimum of 10 years biotech/pharmaceutical industry, with 5 years regulatory experience, including 3 years in development.
• Direct agency interaction experience, preferably ICH regions, as well as exposure across multiple ICH health authorities.
• Team leadership experience, preferably 3 years as direct or matrix manager.
• Clinical (or Device/Combination Product) regulatory experience desired.
• Exposure to market access activities is desired.
• Strong scientific and ethical foundation.
• Applies Servant Leadership and Team Player principles to team environment, including leading without authority.
• Developing strategic ability to assess product vision and apply regulatory lens to effectively articulate regulatory assumptions, opportunities, and risks.
• Experience working effectively across cultures, inclusive and seeks out alternative perspectives when assessing potential outcomes.
• Fluent in English (written & verbal).
What’s on Offer:
• A 6-month contract with a leading biopharmaceutical company based in Bern.
• The opportunity to lead impactful global regulatory strategies and collaborate with cross-functional teams on innovative projects.
• A dynamic and inclusive work environment within a globally renowned organization.
If this sounds like you, don’t hesitate to apply here or contact Veronika von Mentzer, Recruiter: veronika.nakev@swisslinx.com.
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