Global Regulatory Affairs CMC Team Lead
- The GRA CMC Team Lead manages, oversees and develops a team of CMC regulatory professionals and is accountable for CMC regulatory tasks related to product development, registration and license maintenance for the products handled by the team. He/she ensures consistent approaches and development of best practices. The position holder may deputize for the GRA CMC Site Lead.
- As a Change Control Expert, the GRA CMC Team Lead is accountable for the timely regulatory assessment of CMC changes, technical changes related to facility and equipment and/or plasma changes in the Global Change Control (GCC) system in accordance with global regulatory requirements and in close cooperation with GRA Regions. He/she is the first contact point for relevant local technical expert departments regarding regulatory questions related to change control, and may represent GRA in local and global change panels.
- The position holder may represent GRA in local change projects affecting multiple products. In this role he/she will coordinate and consolidate input from all relevant regulatory functions.
- As a Facility & Equipment Expert, the GRA CMC Team Lead is the primary GRA contact point interfacing with relevant technical expert departments for the compilation and maintenance of facility and equipment information for regulatory submissions.
- The position holder may represent Global Regulatory Affairs in Core Project Teams for CMC projects as an expert for regulatory questions related to facility and equipment. The position holder is the primary GRA contact during GMP inspections and for preparation of inspections. He/she coordinates all incoming questions from an inspection within GRA.
- University Degree in natural sciences, further education specialized in Regulatory Affairs would be an asset.
- Minimum 5 years’ experience in biotech or pharmaceutical industry with a minimum of 3 years’ experience in Regulatory Affairs.
- A first experience in line management.
- Sound knowledge in natural sciences with a focus on biological medicinal products would be an asset.
- Sound technical regulatory expertise and understanding of the regulatory framework in more than one key region (US, EU, Japan, CH, or Australia).
- Fluent German and English.
Not yet ready to apply? Sign up to be notified of future opportunities
Serendi is a recruitment service provider with its headquarters in Switzerland. Our clients are large Swiss or international companies.
We manage the entire recruitment process for our client companies - including sourcing of candidates. Candidates are selected based on how well their experience and qualifications match our clients position requirements.
We source and screen thousands of candidates and applications per year and recommend the most qualified candidates to our clients.
If you want to apply for one of the open positions with one of our clients you can do this through this website. Please enter the required data and upload your CV. Our recruitment consultants will screen your application very thoroughly. You will receive via email constant updates on the status of your application. Please apply for each position you are interested in.