Regulatory Affairs Cmc Manager
Vor 5 Tagen
CSL Vifor is a world leading Nephrology, Iron Deficiency and Cardio-Renal pharmaceutical company. We are experiencing rapid growth due to pipeline realization, optimization and innovative alliance partnerships on a global basis.
- Effectively collaborate with technical experts, oversee and direct compilation and update of CMC related dossier components, pro-actively provide input to project planning, evaluation and decision making, and address CMC regulatory questions related to the assigned product(s).
- Evaluate available technical and scientific CMC information for compliance with relevant regulatory requirements, perform gap analysis and propose solutions and strategies to remediate risks.
- Lead the timely provision of compliant global regulatory impact assessments for planned CMC changes.
- Liaise with relevant GRA sub-functions (Product Strategy, International Strategy, LCM) to initiate and oversee the development and implementation of regulatory submission plans for CMC changes and ensure they are suitable to meet business goals.
- Author and manage regulatory CMC documentation in compliance with applicable regulations, and internal procedures, workflows and systems.
- Promote knowledge sharing and development of regulatory expertise within Regulatory Affairs CMC.
- Contribute to the development or improvement and training of regulatory policies and procedures.
**Minimum Requirements**
- MA/MS or equivalent university degree in natural or life sciences
- Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with at least 3 years in Regulatory Affairs, Quality, Pharmaceutical Development or other relevant area.
- Solid technical regulatory expertise.
- Demonstrated understanding of the regulatory framework in at least one key region (US, EU, CH, Japan, China).
- Fluency in English (verbal and written).
**Additional Qualifications**
- Ph.D. or further degree, e.g. in Regulatory Affairs
- Knowledge in Good Manufacturing Practice or Quality Management
- Good command of German (verbal and written).
- Strong team player with a demonstrated ability to develop constructive and effective relationships and successfully influence across all levels of the organization to achieve business goals.
- Thinks solution-oriented and takes a proactive approach in identifying business needs, facilitating information flow and developing new creative approaches.
**About CSL Vifor**:
CSL Vifor aims to become the global leader in iron deficiency and nephrology.
The company is a partner of choice for pharmaceuticals and innovative patient-focused solutions across iron, dialysis, nephrology and rare conditions. CSL Vifor strives to help patients around the world with severe, chronic and rare diseases lead better, healthier lives. It specializes in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision patient care.
**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Vifor**:
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