On behalf of our client, a global biopharmaceutical company (focus on oncology) headquartered in the Basel area and currently having around 12,000 employees worldwide, we are seeking, starting on 01 July 2026 and for an expected term until 31 Dec 2026 (as may be extended) an "Associate, Regulatory Operations (100%; Contractor)". The draft JD reads as follows (with minor adjustments from us):
Responsibilities
* Support the client's expanding portfolio of assets in CH. Responsible for the timely planning, preparation, and coordination of regulatory submissions and for providing regulatory input to cross-functional teams on strategy and execution
* Contribute to cross-functional initiatives and support the development and implementation of regulatory strategies for development programs in alignment with business objectives
* Manage the execution of lifecycle management activities for approved products in CH, ensuring ongoing regulatory compliance and the timely handling of post-approval variations and regulatory commitments to maintain marketing authorizations
* Support the client's Commercial Operations during product launches and throughout the product lifecycle by providing regulatory input on labeling, promotional materials, and local regulatory requirements to ensure compliant product launch and continued marketability of products in CH
* Coordinate the preparation, submission, and lifecycle maintenance of regulatory applications for clinical and non-clinical development, incl. orphan drug applications, paediatric investigation plans (PIPs), and annual reports
* Execute lifecycle management activities for marketed products, incl. product information (PI) updates and review of promotional materials
* Collaborate with cross-functional stakeholders to ensure regulatory strategy is effectively integrated into product development and lifecycle plans
* Support the preparation and coordination of interactions with regulatory authorities, including briefing documents and meeting logistics
* Serve as local regulatory contact for Swissmedic, supporting regulatory interactions and ensuring alignment of submissions and responses with local requirements
* Manage and track regulatory authority queries and commitments in collaboration with subject matter experts; ensure timely and compliant responses and provide status updates as needed
* Maintain regulatory documentation within internal regulatory information management systems, including submission tracking and archiving
* Perform regulatory research to support the development and refinement of regulatory strategies for assigned programs
* Maintain up-to-date knowledge of applicable regulatory requirements and communicate relevant changes internally
Requirements
* Bachelor of Science degree (or higher) in a relevant life sciences or other scientific discipline (or equivalent experience)
* 3-5 years' experience in Regulatory Affairs, incl. submission of marketing authorization applications in CH and demonstrated experience interacting with Swissmedic, familiarity with their portal and systems as well as the national publication platform. Solid understanding of the drug development process and the pharmaceutical and healthcare regulatory environment, incl. applicable guidelines and policy trends. Experience in lifecycle management and post-approval activities would be an asset
* Excellent written and verbal communication skills in German and English (each at least level B2-C1)
* Proven ability to work effectively in cross-functional teams and deliver on objectives with a high level of professionalism
* Strong organizational and planning skills with high attention to detail
* Self-starter with the ability to manage broad responsibilities in a dynamic, fast-paced environment
* Highly motivated and fast-learning individual
* Ability to business travel up to 10%
* Residence in Switzerland (with Swiss work permit) or a cross-border permit (if residence in Germany or France) are required
Place of work: Greater Basel area (with possibility of working from home)
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