Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.
We are currently looking for a Senior Regulatory Affairs CMC Manager to be based in Basel for a 12-months contract position.
As a Senior Regulatory Affairs CMC Manager, you will provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
- 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 (e.g., project plans, strategic documentation, lessons learned);
- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements throughout project lifecycle;
- Prepare CMC responses to health authority questions during development, registration and product lifecycle;
- Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines;
- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible;
- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
- 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;
- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required;
- Bachelor/Advance 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 of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines;
- 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 under pressure of time and workload;
- Effective planning, organizational and interpersonal skills;
- Reasonable approach to risk assessment;
- Excellent written/spoken communication and negotiation skills.