This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!
The Global Regulatory Affairs department of the B. Braun Avitum division has an opportunity for a Regulatory Affairs CMC Manager located at our site in Sempach, Switzerland. In our plant in Sempach, we develop and produce a broad range of products for cleaning and disinfecting instruments, biocidal products for hand and surface disinfection as well as medicinal products for use on skin and in wounds.
Diversity is a part of B. Braun Avitum AG. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity. We are looking for a passionate and talented individual who will act as an entrepreneur of the global infection prevention portfolio.
Tasks & Responsibilities
- Write and maintain all Chemistry Manufacturing Control (CMC) sections of the regulatory files for locally manufactured products within the assigned region.
- Perform due diligence on Modules 2-5 of the local Regulatory files before new registration or acquisition.
- Write the CMC part of Modules 2, 3, 4 and 5 of the local Regulatory dossiers in CTD/eCTD format in English according to EU/local regulatory requirements, in cooperation with the local manufacturers.
- Collect and compile necessary raw data, documents, and samples (active substance, impurities, finished product) to be included in the Regulatory file.
- Update and maintain all CMC sections of the Regulatory files in validated systems (eCTD-Manager).
- Perform deep and accurate due diligence on the local Regulatory dossiers within the MEA region according to internal process/guidance and according to EU/local Region regulatory requirements. Discuss the due diligence outcome and report with all stakeholders and document according to internal guidance.
- Handle variations to the dossier in accordance with the Change Control process in TrackWise system.
- Prepare responses to requests by the Competent Authorities during the evaluation process, and timely handle deficiency letters within a specific timeframe.
- Create and maintain a full up-to-date database and archiving system for tracking the local Regulatory dossiers in the region.
- Effective communication and cross-functional interaction with all involved departments, both on a Regional and Global levels (Regulatory Affairs, Quality Assurance, Quality Control, Production area, Medical Affairs, Pharmacovigilance and Business Development)..
- Forward all received Product Quality Complaints, Adverse Events and Medical Information Requests to the relevant person in Quality Assurance/ Pharmacovigilance/ Medical Affairs.
- Build collaborative relationships with decision-makers and opinion leaders to understand current issues and recognize future trends in the market
- Education in Pharmacy, natural Sciences, Chemist, Bio Chemist, Biotechnologist, or relevant discipline
- More than 3 years professional experience in Regulatory Affairs in the pharmaceutical or related industry
- Knowledge of the structure and the specifics of formation and functioning of the dossier for medicinal products in CTD/eCTD for
- Experience in writing and compiling of Modules 2-3 of the Regulatory dossier in CTD/eCTD formats in English, in close collaboration with local regulatory requirements
- Experience in due diligence of the Regulatory dossier according to EU and local regulatory requirements
- Knowledge of current legislation and corporate requirements governing regulatory activities (registrations, renewals, variations)
- Confident knowledge and power user of specialized regulatory programs and databases.
- Ability to maintain a structured documentation and archiving system
- Very good written and spoken English and German skills (any additional skills are beneficial)