Responsibilities:
- Develop/contribute/review content and format according to country regulatory guidelines for regulatory submissions (major and minor submissions, PSURs, MSSRs etc.), Swissmedic meeting requests, variations, notifications and other regulatory activities.
- Work with Global Regulatory Science and Global cross-functional project teams regarding the development and execution of regulatory strategy through the clinical development processes to post-market activity.
- Responsible for coordinating aspects of regulatory submissions relevant to assigned projects or programs.
- Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
- Contribute to the development and implementation of clinical and pre-clinical regulatory strategy for projects in all stages of development (CTA through commercial).
- Maintain Swiss labelling (SmPC, PIL, artwork and packaging) in alignment with regulatory requirements and Global labeling/core-datasheet.
Skills:
- BA/BS degree in a scientific/engineering/healthcare discipline required, Masters, PharmD or PhD preferred.
- 5-8+ years of experience in Regulatory Affairs or related field
- Experience in biologics, vaccines essential, Rare or Autoimmune Diseases and Oncology is preferred
- Strong knowledge of current Swissmedic regulations, eCTD and EMA or other international regulatory processes.
- Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements. Strong experience with CTD format and eCTD submission builds, including preparation of Module 1 documents
- Proven ability to liaise with Regulatory Agencies
- Excellent command of spoken and written German and English languages is a must.
- Experience with developing and implementing gap analysis and related competitive regulatory strategies
- Advanced problem-solving ability and a drive to generate compliant regulatory solutions prior to elevation of topics to manager
EU (Hybrid): Sr. Regulatory Manager (235836)
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