For our client, an International firm within the Healthcare & Life Sciences based in Basel, Swisslinx is seeking a highly motivated individual to take on a challenging role as a Senior Regulatory CMC Manager. This is a great opportunity to bring your proven knowledge and expertise to an organization that offers a dynamic working environment.
Your mission: - Formulate, lead and drive global CMC regulatory strategy with a focus on innovation, maximizing the business benefit balanced with regulatory compliance - Support implementation of all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products - Produce high quality strategic project documentation and presentations - Author high-quality CMC documentation for HA submission - Prepare CMC responses to health authority questions during development, registration and product lifecycle - Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned - Establish and maintain sound working relationships with partners and customers
Your background: - Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent - Regulatory experience preferred, and/or experience in drug/biopharmaceuticals - Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology - Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable - Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects - Effective planning, organizational and interpersonal skills - Reasonable approach to risk assessment. - Fluency in English, German desired By applying for this position, I consent to the Swisslinx Group of companies: - storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities - using my personal information or - supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities - transferring where applicable my personal information to a country outside the EEA/EFTA