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16363en
- Contract
- English
- Mid-Senior level
- Legal, Regulatory & Compliance
- Zurich
- Healthcare & Life Sciences
Cette offre a maintenant expiré
On behalf of our client, an international biopharmaceutical company, Swisslinx is looking for a Regulatory affairs lead EUCAN GI and inflammation. In this role, you will drive regional regulatory strategy to secure faster approvals and access for groundbreaking medicines, collaborating globally to shape the future of patient care.
Contract type - Contract
Start Date - ASAP
Location - Zurich
Workload - 100%
Duration - 6 months
Work type - hybrid: in office 5 days per month
Your mission:
• Develop, define, and lead regional regulatory strategies to achieve approvals and improve patient access, in alignment with program objectives, under senior team guidance.
• Provide clear, objective assessments of regulatory strategy success likelihoods to inform decision-making.
• Offer strategic and tactical regulatory advice to ensure efficient, compliant development programs.
• Lead the Regional Working Team and represent the region on global and project teams as needed.
• Serve as a regional regulatory expert for assigned projects within therapeutic areas.
• Occasionally manage interactions with EMA and national health authorities in collaboration with senior team members.
• Ensure regulatory strategies are well-documented, reviewed, and executed according to plans.
• Coordinate with regional and market access teams to align on regulatory and health authority strategies.
• Identify and communicate relevant regulatory requirements and emerging trends within the region.
• Build and maintain effective relationships with cross-functional, regional, and global teams.
• Manage regulatory submissions to ensure timely product approvals throughout development and lifecycle.
• Engage and build influence with external stakeholders (e.g., regulatory agencies, industry experts) to support strategic goals.
• Support regional and global colleagues to resolve conflicts and align on comprehensive regulatory strategies.
• Under supervision, represent the company in Health Authority meetings and communicate outcomes effectively.
• Provide strategic input on regulatory matters for licensing, development, and marketed product opportunities.
• Present regional regulatory strategies and insights to senior management when required.
Your background:
• BSc in a scientific field required; an advanced degree is preferred.
• Significant experience in regulatory affairs, with a strong understanding of EU regulations for drugs and biologics in both development and post-marketing phases.
• Demonstrated skill in managing multiple filings or programs, particularly within the EU, with global involvement a plus.
• Strong communication, negotiation, and project management skills, with an ability to influence senior leadership and collaborate across global teams.
• Proactive, solution-oriented approach to regulatory challenges, with experience managing CRO or contractor relationships preferred.
What's on offer
• A six-month contract.
• A chance to develop your career at an internationally known biotechnology company.
• A competitive salary.
• A flexible work style, with only 5 days required in the office each month.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
Contract type - Contract
Start Date - ASAP
Location - Zurich
Workload - 100%
Duration - 6 months
Work type - hybrid: in office 5 days per month
Your mission:
• Develop, define, and lead regional regulatory strategies to achieve approvals and improve patient access, in alignment with program objectives, under senior team guidance.
• Provide clear, objective assessments of regulatory strategy success likelihoods to inform decision-making.
• Offer strategic and tactical regulatory advice to ensure efficient, compliant development programs.
• Lead the Regional Working Team and represent the region on global and project teams as needed.
• Serve as a regional regulatory expert for assigned projects within therapeutic areas.
• Occasionally manage interactions with EMA and national health authorities in collaboration with senior team members.
• Ensure regulatory strategies are well-documented, reviewed, and executed according to plans.
• Coordinate with regional and market access teams to align on regulatory and health authority strategies.
• Identify and communicate relevant regulatory requirements and emerging trends within the region.
• Build and maintain effective relationships with cross-functional, regional, and global teams.
• Manage regulatory submissions to ensure timely product approvals throughout development and lifecycle.
• Engage and build influence with external stakeholders (e.g., regulatory agencies, industry experts) to support strategic goals.
• Support regional and global colleagues to resolve conflicts and align on comprehensive regulatory strategies.
• Under supervision, represent the company in Health Authority meetings and communicate outcomes effectively.
• Provide strategic input on regulatory matters for licensing, development, and marketed product opportunities.
• Present regional regulatory strategies and insights to senior management when required.
Your background:
• BSc in a scientific field required; an advanced degree is preferred.
• Significant experience in regulatory affairs, with a strong understanding of EU regulations for drugs and biologics in both development and post-marketing phases.
• Demonstrated skill in managing multiple filings or programs, particularly within the EU, with global involvement a plus.
• Strong communication, negotiation, and project management skills, with an ability to influence senior leadership and collaborate across global teams.
• Proactive, solution-oriented approach to regulatory challenges, with experience managing CRO or contractor relationships preferred.
What's on offer
• A six-month contract.
• A chance to develop your career at an internationally known biotechnology company.
• A competitive salary.
• A flexible work style, with only 5 days required in the office each month.
If this sounds like you, don’t hesitate to apply here or reach out directly to Hugo Palejowski, Recruiter: hugo.palejowski@swisslinx.com.
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