Regulatory Affairs Manager (f/m/d)

Lonza; Basel; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

Agile culture

Inclusive workplace

Compensation programs

Benefits package

Zusammenfassung

Lonza in Visp, Switzerland, seeks an experienced Manager Regulatory Affairs to lead end-to-end regulatory programs at the manufacturing site. You will shape regulatory strategies, coordinate cross-functional teams, and ensure timely delivery for complex projects, including health authority interactions and lifecycle activities.

The role requires a strong background in GMP environments, excellent stakeholder management, and fluency in English with German as an advantage.

Qualifikationen

• Academic degree in Chemistry, Biochemistry, Pharmacy, or related discipline.
• Solid experience in pharmaceutical, chemical, or biotech industry, ideally within CDMO environments and GMP manufacturing.
• Experience in cross-functional, client-driven environments with understanding of GMP, quality systems, and manufacturing processes.
• Experience contributing to regulatory activities (e.g., submissions, lifecycle management, health authority interactions) is a strong advantage.
• Strong stakeholder management and communication skills; ability to collaborate across QA, QC, MSAT, Production, and Supply Chain.
• Excellent command of English; German is an advantage; familiarity with TrackWise, LIMS, Documentum or Veeva is a plus.

Aufgaben

• Lead end-to-end regulatory activities for Visp client programs.
• Act as Regulatory Affairs Project Lead, aligning strategy, timelines, and deliverables with program objectives.
• Coordinate regulatory workstreams across internal functions and global RA networks.
• Drive prioritization, planning, and tracking of regulatory deliverables across multiple programs.
• Oversee preparation, review, and delivery of regulatory documentation and health authority responses.
• Support lifecycle management, inspections readiness, and regulatory compliance across projects.

Kenntnisse

Regulatory leadership

CMC strategy

Cross-functional leadership

Regulatory submissions

Health Authority liaison

Project management

GMP knowledge

English & German

Ausbildung

Academic degree in Chemistry, Biochemistry, or Pharmacy

Tools

TrackWise

LIMS

Documentum

Veeva

Jobbeschreibung

Location: the actual location of this job is in Visp, Basel, Switzerland. Relocation assistance is available for eligible candidates and their families, if needed. This is a temporary position for a period of one year.

As a Manager Regulatory Affairs based at our manufacturing site in Visp , you provide end-to-end regulatory leadership for complex client programs supported by the site. You are accountable for shaping and executing robust regulatory strategies that enable efficient development, manufacturing, and commercialization.

You act as a trusted regulatory advisor to cross-functional teams and clients , ensuring proactive risk management, alignment of regulatory expectations, and seamless integration of regulatory requirements into project execution.

By orchestrating regulatory activities across functions and geographies, you ensure the high-quality, compliant, and timely delivery of regulatory milestones , strengthening the Visp site’s ability to execute complex programs and enhancing Lonza’s position as a manufacturer of choice for highly complex molecules including bioconjugation projects.

What you will get:

• An agile career and dynamic working culture
• An inclusive and ethical workplace
• Compensation programs that recognize high performance
• A variety of benefits dependent on role and location

The full list of our global benefits can be also found on https://www.lonza.com/careers/benefits.

What you will do:

Project Leadership & Regulatory Coordination:

• Lead end-to-end regulatory activities for assigned Visp client programs.
• Act as Regulatory Affairs Project Lead, ensuring alignment of regulatory strategy, timelines, and deliverables with overall program objectives.
• Coordinate regulatory workstreams across internal functions and global RA networks, ensuring seamless execution and transparency.
• Drive prioritization, planning, and tracking of regulatory deliverables across multiple concurrent programs.

Operational Oversight & Execution:

• Ensure efficient execution of day-to-day regulatory activities supporting client programs, including submissions, lifecycle management, and health authority interactions.
• Oversee preparation, review, and delivery of high-quality regulatory documentation (e.g., dossier content, responses to Health Authority queries, briefing packages).
• Support teams in managing competing priorities and resolving operational challenges in a timely manner.

Regulatory Strategy & Compliance:

• Support customers with CMC strategies in alignment with global requirements and customer expectations.
• Ensure all regulatory activities are compliant with applicable guidelines, registered dossiers, and Lonza procedures.
• Provide regulatory assessment of changes, deviations, and lifecycle activities, ensuring alignment with regulatory filings and strategy.
• Ensure consistent interpretation and application of regulatory requirements across projects and technologies.
• Support the Lonza Regulatory Information Bulletin.

Customer & Stakeholder Management:

• Act as primary regulatory interface for customers on assigned programs, providing expert guidance on CMC regulatory topics and strategy.
• Build and maintain strong, trust-based relationships with customers and key internal stakeholders (e.g., MSAT, Quality, Production, Supply Chain).
• Support customer interactions with Health Authorities, including preparation and participation in meetings and responses.
• Ensure clear, proactive communication of regulatory risks, timelines, and deliverables to all stakeholders.

Continuous Improvement & Regulatory Excellence:

• Contribute to strengthening regulatory capabilities at the Visp site, ensuring scalability and consistency across programs.
• Support inspection readiness, ensuring high standards of compliance and documentation.
• Proactively identify risks and improvement opportunities, implementing mitigation strategies to ensure reliable program delivery.

What we are looking for:

• Academic degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline
• Solid experience in the pharmaceutical, chemical, or biotech industry, ideally within CDMO environments and GMP-regulated manufacturing and proven experience in functions such as Quality Control (QC), Quality Assurance (QA), Regulatory Affairs, or Program/Project Management, with strong exposure to manufacturing operations (preferably Small Molecules, Conjugates or related technologies)
• Demonstrated ability to work in cross-functional, client-driven environments , with a strong understanding of how to translate customer and regulatory requirements into operational execution. Good understanding of GMP regulations, quality systems, and manufacturing processes , with the ability to apply regulatory requirements in a pragmatic, solution-oriented manner
• Experience contributing to or supporting regulatory activities (e.g. submissions, lifecycle management, change assessments, or health authority interactions) is a strong advantage
• Strong stakeholder management and communication skills , with the ability to collaborate effectively across functions (e.g. QA, QC, MSAT, Production, Supply Chain) and interact confidently with customers
• Structured, proactive, and solution-oriented working style with a strong sense of ownership and accountability in a dynamic CDMO environment and ability to balance compliance, customer expectations, and operational feasibility , ensuring efficient and reliable delivery of program objectives
• Excellent communication skills in English and Germanis an advantage and experience with relevant systems (e.g. TrackWise, LIMS, Documentum, Veeva) is an advantage.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.