Head of Regulatory Affairs

Datwyler Group; Altdorf (UR); Remote; CHF 180,000 - 260,000; Full time

Benefits offered by this job

Competitive compensation

Global exposure

Development opportunities

Job summary

Datwyler seeks a Head of Regulatory Affairs to establish and lead a strategic regulatory capability across Healthcare’s injectable primary packaging and other markets. You will define strategy, oversee submissions, and partner with R&D, Quality, Manufacturing, Commercial, and Legal to position regulatory excellence as a value driver.

You will drive a global regulatory function, build governance and processes, and ensure proactive intelligence on evolving regulations while leading a

Qualifications

• Master's degree or PhD in Pharmacy, Chemistry, Biomedical Engineering, Materials Science, Regulatory Affairs, or related field.
• Minimum 10 years of Regulatory Affairs experience in the pharmaceutical industry.
• At least 5 years of leadership experience in a global organization.
• Strong understanding of international regulatory frameworks and healthcare industry requirements.

Responsibilities

• Develop and lead Datwyler's global Regulatory Affairs strategy.
• Monitor evolving regulatory requirements and industry trends worldwide.
• Provide strategic regulatory guidance for new products, materials and growth initiatives.
• Translate regulatory developments into actionable business recommendations.
• Build regulatory roadmaps to support growth and competitiveness.
• Oversee regulatory documentation and submissions for customers and business needs.
• Drive regulatory assessment in product lifecycle and change management.

Skills

Leadership

Regulatory strategy

Global regulatory

Stakeholder mgmt

Regulatory guidance

Education

Master's degree

PhD

Job description

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In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high-tech company focuses on high-quality, system-critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million.

Our employees are the heart of Datwyler - we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100-year corporate history. Become part of our great team as a...

Head of Regulatory Affair s

The Head of Regulatory Affairsestablishes and leads Regulatory Affairs as a strategic capability for Datwyler, anchored first in Healthcare’s injectable primary packaging business and designed to scale over time across Datwyler’s broader served markets, including Medical Device, Food & Beverage, and selected industrial applications.

As the global regulatory leader, the position defines Datwyler’s regulatory affairs strategy across applicable frameworks, regulations, standards, and customer expectations, prioritizing the regulatory complexity and business criticality of Healthcare while progressively extending regulatory discipline to other markets as the function matures.

The role provides strategic leadership across Regulatory Affairs and partners closely with R&D, Product Management, Quality, Manufacturing, Operations, Commercial, Legal, external customers, regulatory bodies, and Notified Bodies to position regulatory capability as a source of compliance confidence, customer trust, and enterprise value creation.

Your Responsibilities

• Develop and execute Datwyler's global Regulatory Affairs strategy
• Monitor and interpret evolving regulatory requirements and industry trends across global markets
• Provide strategic regulatory guidance for new products, materials, technologies, and growth initiatives
• Translate regulatory developments into business insights and actionable recommendations
• Build regulatory roadmaps that support business growth and long-term competitiveness

Lead Regulatory Strategy

• Ensure regulatory compliance throughout the lifecycle of healthcare products and related product portfolios
• Oversee regulatory documentation and submissions supporting customer and business requirements
• Drive regulatory assessment processes as part of product lifecycle and change management activities
• Ensure regulatory considerations are integrated into development, manufacturing, and commercial processes
• Support global change notification and customer communication activities
• Establish a proactive regulatory intelligence capability covering relevant global regulations, standards, and industry requirements
• Assess emerging regulatory trends and evaluate potential business impact
• Represent Datwyler in industry associations, technical committees, and regulatory forums
• Build strong relationships with external stakeholders, including customers and regulatory authorities

Partner with Customers

• Provide regulatory expertise to customers throughout product development, qualification, and commercialization activities
• Support customer submissions with the required scientific and regulatory documentation
• Participate in customer audits, technical discussions, and strategic reviews
• Serve as a trusted regulatory advisor in key customer engagements

Build and Lead the Global Function

• Develop and lead a high-performing global Regulatory Affairs organization
• Establish governance, processes, and best practices that support sustainable growth
• Collaborate closely with cross-functional teams including R&D, Quality, Manufacturing, Operations, Commercial, and Legal
• Promote a strong regulatory culture across the organization through coaching, training, and knowledge sharing
• Support innovation initiatives through early regulatory engagement and strategic guidance

Your Profile

• Master's degree or PhD in Pharmacy, Chemistry, Biomedical Engineering, Materials Science, Regulatory Affairs, or a related scientific field
• Minimum 10 years of Regulatory Affairs experience within the pharmaceutical industry
• At least 5 years of leadership experience within a global organization
• Strong understanding of international regulatory frameworks and healthcare industry requirements
• Experience interacting with regulatory authorities, customers, industry associations, and external stakeholders
• Proven track record of building regulatory strategies and influencing business decisions
• Strong leadership, stakeholder management, and communication skills
• Ability to operate effectively in a global, matrix organization
• Strategic mindset combined with a pragmatic, hands-on approach
• Passion for continuous improvement, innovation, and customer success

What We Offer

• A unique opportunity to build and shape a global Regulatory Affairs function
• High visibility and influence within a leading international healthcare organization
• The chance to work at the intersection of innovation, quality, and regulatory excellence
• An entrepreneurial environment where you can make a lasting impact on the future of the business
• Competitive compensation and development opportunities within a global company

Be yourself at Datwyler

We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.