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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Regulatory Affairs, including end-to-end regulatory activities, compliance with GMP regulations, and effective stakeholder management. Proficient in preparing regulatory documentation and managing customer interactions with health authorities.
Highest-signal resume keywords
Regulatory Affairs Project LeadGMP RegulationsQuality Control (QC)Quality Assurance (QA)Regulatory Submissions
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory DocumentationLifecycle ManagementChange AssessmentsHealth Authority InteractionsCMC StrategiesManufacturing OperationsSmall MoleculesConjugatesProgram/Project ManagementQuality Systems
Soft Skills
Stakeholder ManagementCommunication SkillsProactive Working StyleSolution-Oriented ApproachOwnership and Accountability
Tools & Technologies
TrackWiseLIMSDocumentumVeeva
Industry Keywords
Pharmaceutical IndustryChemical IndustryBiotech IndustryCDMO EnvironmentGMP-Regulated Manufacturing
About the role
Key responsibilities & impact- Lead end-to-end regulatory activities for assigned Visp client programs
- Act as Regulatory Affairs Project Lead and align regulatory strategy, timelines, and deliverables with program objectives
- Coordinate regulatory workstreams across internal functions and global regulatory affairs networks
- Prioritize, plan, and track regulatory deliverables across concurrent programs
- Oversee day-to-day regulatory activities, including submissions, lifecycle management, and health authority interactions
- Prepare, review, and deliver regulatory documentation, dossier content, health authority responses, and briefing packages
- Support teams in managing competing priorities and resolving operational challenges
- Support customers with CMC strategies aligned with global requirements and expectations
- Ensure regulatory activities comply with applicable guidelines, registered dossiers, and Lonza procedures
- Assess changes, deviations, and lifecycle activities against regulatory filings and strategy
- Support the Lonza Regulatory Information Bulletin
- Serve as the primary regulatory interface for customers on assigned programs
- Build relationships with customers and internal stakeholders including MSAT, Quality, Production, and Supply Chain
- Support customer interactions with health authorities, including meeting preparation, participation, and responses
- Communicate regulatory risks, timelines, and deliverables proactively
- Strengthen regulatory capabilities at the Visp site and support scalability and consistency
- Support inspection readiness and high standards of compliance and documentation
- Identify risks and improvement opportunities and implement mitigation strategies
Requirements
What you’ll need- Academic degree in Chemistry, Biochemistry, Pharmacy, or a related scientific discipline
- Solid experience in the pharmaceutical, chemical, or biotech industry
- Experience ideally within CDMO environments and GMP-regulated manufacturing
- Proven experience in Quality Control (QC), Quality Assurance (QA), Regulatory Affairs, or Program/Project Management
- Strong exposure to manufacturing operations, preferably Small Molecules, Conjugates, or related technologies
- Ability to work in cross-functional, client-driven environments
- Strong understanding of translating customer and regulatory requirements into operational execution
- Good understanding of GMP regulations, quality systems, and manufacturing processes
- Experience contributing to or supporting regulatory activities, such as submissions, lifecycle management, change assessments, or health authority interactions, is a strong advantage
- Strong stakeholder management and communication skills
- Ability to collaborate across QA, QC, MSAT, Production, and Supply Chain and interact confidently with customers
- Structured, proactive, and solution-oriented working style
- Strong sense of ownership and accountability in a dynamic CDMO environment
- Ability to balance compliance, customer expectations, and operational feasibility
- Excellent communication skills in English
- German is an advantage
- Experience with TrackWise, LIMS, Documentum, or Veeva is an advantage
Benefits
Comp & perks- Relocation assistance for eligible candidates and their families
- Agile career and dynamic working culture
- Inclusive and ethical workplace
- Compensation programs that recognize high performance
- Variety of benefits dependent on role and location
- Global benefits program