Lausanne, Vaud, ch Business and Financial Operations Occupations
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Write, review and assemble high quality regulatory submissions, such as Quality Modules of Marketing Authorization Applications (MAA/NDA/BLA), Investigational New Drug (IND/IMPD), Variations, pre-IND briefing documents, etc.;
Participate as team member, leader, or advisor in a number of the company’s projects, in an international environment
Serve as in-house regulatory expert for internal and external projects
Participate to the definition and implementation of CMC regulatory strategies for development and registration of innovative drugs;
Provide advice on operational and technical CMC subjects (Manufacturing, analytical development, validation, specification setting, stability, etc.);
Provide support for the preparation of Agency meetings (EU and US);
Monitor, prioritize and supervise projects’ strategy, timelines, and milestones and communicate them to the project team members;
Ensure compliance with regulations and applicable guidelines;
Stay up to date with CMC EU and US trends and requirements.
At least 2 years proven professional CMC (small molecules and/or biologicals) experience;
Additional 2 years of regulatory experience is preferred;
Demonstrated ability to manage and build relationships with colleagues and regulatory authorities;
Experience with Project Management is a plus;
Direct interactions with the Health Authorities is a plus;
Experience in a consulting environment is a plus.
Personal attributes and skills:
Strong problem solving skills
High motivation and flexibility;
Client- and business-oriented;
Proven ability to meet deadlines;
Ability to work in a multicultural environment;
Proactive and enthusiastic approach to collaboration with internal and client teams;
Strong written and verbal communication, presentation, and facilitation skills;
Excellent working knowledge of MS Office (Word, Excel, PowerPoint) is essential.