Regulatory Operations Consultant
Posted 1 hour 16 minutes ago by Swisslinx AG
Permanent
Not Specified
Other
Not Specified, Switzerland
Job Description
Regulatory Operations Consultant
Our client, an innovative pharmaceutical company, is seeking a Regulatory Operations Consultant III to support its growing portfolio in Switzerland.
Regulatory Operations Consultant
Job description:
Location: Basel
Start Date: July 2026
Duration: Until December 2026
Workload: 100%
Requirements:
Coordinate the preparation, submission, and maintenance of regulatory applications for clinical and non-clinical development programs
Support lifecycle management activities for marketed products, including product information updates and promotional material reviews
Contribute to the development and implementation of regulatory strategies aligned with business objectives
Collaborate closely with cross-functional teams to integrate regulatory requirements into development and lifecycle plans
Support interactions with regulatory authorities, including preparation of briefing documents and meeting coordination
Act as a local regulatory contact for Swissmedic and ensure submissions meet local requirements
Manage regulatory authority questions, commitments, and responses in collaboration with internal stakeholders
Maintain regulatory documentation, submission tracking, and archiving within regulatory systems
Conduct regulatory research and monitor changes in applicable regulations and guidelines
Support commercial teams during product launches and throughout the product lifecycle by providing regulatory guidance
Competences:
Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline
3-5 years of experience within Regulatory Affairs in the pharmaceutical industry
Experience interacting directly with Swissmedic
Experience with Swiss marketing authorisation applications (MAAs)
Familiarity with Swissmedic systems, including the Swissmedic Portal and national publication platform
Solid understanding of drug development and the pharmaceutical regulatory environment
Experience with lifecycle management and post-approval activities is an advantage
Strong stakeholder management and cross-functional collaboration skills
Fluent German and English, both written and spoken
Strong organisational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment jid6218ecba jit0623a jiy26a
Our client, an innovative pharmaceutical company, is seeking a Regulatory Operations Consultant III to support its growing portfolio in Switzerland.
Regulatory Operations Consultant
Job description:
Location: Basel
Start Date: July 2026
Duration: Until December 2026
Workload: 100%
Requirements:
Coordinate the preparation, submission, and maintenance of regulatory applications for clinical and non-clinical development programs
Support lifecycle management activities for marketed products, including product information updates and promotional material reviews
Contribute to the development and implementation of regulatory strategies aligned with business objectives
Collaborate closely with cross-functional teams to integrate regulatory requirements into development and lifecycle plans
Support interactions with regulatory authorities, including preparation of briefing documents and meeting coordination
Act as a local regulatory contact for Swissmedic and ensure submissions meet local requirements
Manage regulatory authority questions, commitments, and responses in collaboration with internal stakeholders
Maintain regulatory documentation, submission tracking, and archiving within regulatory systems
Conduct regulatory research and monitor changes in applicable regulations and guidelines
Support commercial teams during product launches and throughout the product lifecycle by providing regulatory guidance
Competences:
Bachelor's degree in Life Sciences, Pharmacy, Biology, Chemistry, or a related scientific discipline
3-5 years of experience within Regulatory Affairs in the pharmaceutical industry
Experience interacting directly with Swissmedic
Experience with Swiss marketing authorisation applications (MAAs)
Familiarity with Swissmedic systems, including the Swissmedic Portal and national publication platform
Solid understanding of drug development and the pharmaceutical regulatory environment
Experience with lifecycle management and post-approval activities is an advantage
Strong stakeholder management and cross-functional collaboration skills
Fluent German and English, both written and spoken
Strong organisational skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment jid6218ecba jit0623a jiy26a