(Senior) Manager Regulatory Affairs (a)

Description du poste

* International Pharma Company * Temporary contract with extension option ## About Our Client ## Our client is a biotechnology company in Basel that operates in the pharmaceutical industry, with a focus on the development and commercialization of innovative drugs in the areas of high unmet medical needs (oncology, immunology). ## Job Description ## Depending on the experience level of the candidate, the responsibilities are as follows: * Coordinate the preparation, submission, management and maintenance of submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: CTAs, amendments and requests for information, Orphan drug applications, Paediatric Investigation Plans and Annual Reports * Life cycle maintenance activities for marketed products including management information updates and assessment of promotional materials. * Collaborate with key internal stakeholders to ensure the regulatory strategy is incorporated and implemented in line with product development objectives. * Assist in coordination and preparation for Agency meetings and associated briefing document preparation. * Collaborate with cross-functional teams to ensure alignment on regulatory requirements. * Manage and track queries and commitments with regulatory agencies,collaborate with subject matter experts to respond to queries, provide updates regarding regulatory submissions, conditions/commitments. * Manages regulatory documents in internal Regulatory Information Management system including tracking submissions and archiving. * Provide representation for study-level regulatory activities and participate in cross-functional project teams and product development activities/meetings. * Perform research to support the development of regulatory strategy for the assigned clinical development programs. ## The Successful Applicant ## To be successful in this role, the candidate must have: * Degree in a life sciences discipline * 3-5 years' experience in a Regulatory capacity * Demonstrated experience of contact and relationship with **Swiss Medic** is an absolute MUST * Regulatory experience with **CTAs and MAAs** in Switzerland required * Good understanding of drug development process and the pharmaceutical healthcare environment including regulatory requirements and policy trends * Excellent oral and written communications skills in **both German** and **English** ## What's on Offer ## * 100% remote work (homebase must be in Switzerland) * An opportunity to work in a thriving innovative biotech company * Opportunities to expand your expertise in regulatory affairs Quote job ref JN-052026-7023979 Job Function Healthcare & Life Sciences Specialisation Regulatory Affairs Industry Healthcare / Pharmaceutical Location Basel-City Contract Type Interim Job Reference JN-052026-7023979 Job Nature Home Office