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12342en
- Contract
- English
- Mid-Senior level
- Research & Development
- Basel
- Healthcare & Life Sciences
Skills
Regulatory Affairs, CMC, HA Submission, Regulatory Strategy
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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.
Job Title: Senior Regulatory CMC Manager
Duration: 12 months
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
Job Title: Senior Regulatory CMC Manager
Duration: 12 months
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
