CMC Regulatory Manager
In our Headquarter in St-Prex/Lausanne (Switzerland), we are looking for a:
- Define, lead and drive projects, from project initiation to closure including after actions reviews covering the full Product Supply scope (Technical, Operational Excellence and PS Projects)
- Active participations in design, trial execution and data analysis associated with the projects. Follow-up, writing and reviewing documentation including project plans, test protocols, risk assessment, reports to secure delivery according to plans
- Proactively review and support manufacturing/analytical improvements/changes in collaboration with the relevant manufacturing/QC testing site(s)
- Provide support for technical and regulatory CMC matters related to specified products. Assist with writing, reviewing and approving of CMC documentation in connection with submissions/responses to regulatory agencies.
- Transfer Product knowledge from the sending unit to receiving unit and Product Steward/Contact. Partner with R&D, TPMs, and CROs to ensure knowledge is captured and transferred.
- Act as Technical Product Manager for a Ferring product. The Technical Manager will represent a first point of contact within Ferring organisation for all technical support related to the product and will proactively support product or manufacturing improvements in collaboration with the relevant manufacturing site, including requirements related to Continued Process Verification.
- Participate in cross functional teams to create and implement manuals, guidelines, tools to facilitate and structure working processes within Ferring
- Degree in pharmacy. Engineer or university degree in a related scientific discipline (chemistry, biology, biotech, microbiology).
- At least 5 years’ experience in pharmaceutical/biotechnology development or production with project management experience.
- Good knowledge of various types of pharmaceutical Manufacturing technologies and analytical QC methods.
- Experience with validation of pharmaceutical processes and analytical methods according to current guidelines.
- Signiﬁcant practice (+5 years) of the registration procedures and CTD writing.
- Excellent leadership skills and ability to inﬂuence and work across organisational boundaries.
- Good communication skills excellent command of English and preferably another European language.
- Ability to work well as an integral part of a large Project Team but also as a self-starter.
- Effective leader and keen on working in a cross-cultural environment.
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