QA Regulatory Affairs Supervisor
- Responsible for preparing and updating Common Technical Documents (CTD) Module 2/Module 3 quality documents and review CTD prepared by Pharm. Development, qualification / validation, Operations, QC, etc.
- Manage a team of 2/3 persons
- Answer technical questions raised by Global Regulatory Affairs, affiliates and regulatory agencies during product registration procedures (new applications, variations, renewals, annual reports, commitments, tenders)
- Maintain currency and consistency of regulatory documentation managed by plant QA in several regulatory data bases.
- Approve plant drug product specifications in LIMS, in compliance with applicable registered specifications
- Support QA teams to manage and review change requests and assess their regulatory impact
- Manage change control activities for the plant
- Scientific degree (pharmacy, chemistry, biology or equivalent)
- Experience in the pharmaceutical industry and GMP environment (5-7 years’ experience)
- Experience in scientific writing (in English) : CTD Module 2/Module 3 documents (Worldwide environment: EU, US, China, Japan, LatAm, META)
- Analytical skills, ability to handle several tasks simultaneously and with high accuracy, Ability to synthesize.
- Capability to work under pressure in a complex matrix organization and demanding business networking
- Fluent in 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.