For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
Senior Regulatory CMC Manager (m/f), 100%, Basel
- 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, etc.)
- 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.
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
- Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
- Languages: Fluent English required (oral and written).
- Good skills in site (local) language desired (oral)
- 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.
- Computer literacy.
Work Place: Basel
Start Date: October 2020
End Date: September 2021
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Insa Voss (+41 61 270 80 07).