Full-Time Regulatory Affairs CMC Manager
Regulatory Affairs CMC Manager
Permanent: 41 hours pw
Salary: 130,000CHF (Negotiable DOE) + benefits package
My client is a global leader in protein biologics and novel Bio-therapeutics. They currently strive to research, develop and manufacture therapies to treat serious and rare illnesses and genetic diseases.
Their areas of research touches on disorders of the blood (such as coagulation) and immune deficiency diseases. They are looking for an ambitus and driven Regulatory Affairs Manager to join their growing team in their Bern offices, which is just one of their offices across a global collection of 19 in total.
Main Responsibilities and Accountabilities
- Develops and executes global regulatory strategies in close collaboration with the site Quality and Manufacturing;
- Departments and with regional regulatory experts to license product changes;
- Develops and executes global regulatory strategies to obtain new marketing authorizations worldwide of established product in agreement with the commercial organization;
- Represents the Global Regulatory Affairs function in cross-functional project teams;
- Responsible for the maintenance of the content of regulatory submissions of the licensed products from the site of manufacture, meeting appropriate standards and content requirements;
- Responsible for the compilation of relevant high quality documentation for CMC submissions according to agreed schedules while taking into account regional specific requirements;
- Authors the CMC dossier narratives for the comprehensive CTDs;
- Coordinates the compilation and updates of technical documentation with expert departments;
- Compiles CMC documentation in preparation of Scientific Advice Meetings, contributes to and participates at Scientific Advice Meetings;
- Evaluates the CMC technical and scientific information for compliance with regulatory requirements, identifies deficiencies and proposes strategies to remediate risks;
- Compiles the CMC part of Base Dossiers for new marketing authorization applications in relevant countries;
- Contributes to the review of the CMC sections of the Investigator’s Brochures and product information/package leaflets;
- Contributes to the review of CMC related information for marketing product monographs and other promotional marketing documents;
- Responsible for regulatory support during international Health Authorities Inspections or Customers Audits;
- Assesses and communicates inspectional findings applicable to product(s).
Qualifications & Experience
- BS/BA/Masters/PhD in Natural Science (Preferably a degree in Regulatory Affairs);
- Two to three years of experience in the pharmaceutical industry, knowledge of the global regulatory environment and CMC;
- Strong background in natural sciences with a focus on biological medicinal products, ideally plasma-derived and recombinant products;
- Excellent communication, project management, planning, problem solving and presentation skills;
- Flexibility to work in a global regulatory cross-cultural work environment and can work independently as well as in a team;
- Fluent in English, German is a plus.
If you feel you match the skills and experience necessary to apply for this position you can apply directly on our company website.
How to Applyhttps://www.leap29.com/jobs/3jWmb/regulatory-affairs-cmc-manager-bern-switzerland-switzerland-europe
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