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Regulatory Affairs Director of Cmc
vor 2 Wochen
Hobson Prior are currently seeking for a Regulatory Affairs Director of CMC to join a brilliant pharmaceutical organisation on permanent basis with the ability to work across various sites in Europe. Our client is focused on providing the best possible remedies to protect the health and wellbeing of people.
Please note that to be considered for this role you must have the right to work in this location.
**Key Responsibilities**:
- For this role you will be guiding interactions with health agencies to approve on CMC regulatory methods and data needs to enable successful approval of allocated products/projects.
- Participate in CMC process initiatives to assist in the production of internal international and local SOPs and guidance papers.
- Offer training and direction to less experience personnel in the EU CMC regulatory team.
- You will anticipate when and how regulatory problems may influence the business and conscientiously and swiftly advice project teams and management appropriately.
- Any other assigned duties.
**Requirements**:
- Familiarity with small molecule dosage forms as well as with biological products which would be beneficial for the role.
- Comprehension of eCTD needs and familiarity with planning CMC documentation for new product EU MAAs such as Module 3, Module 2 QOS, Module 1 Quality connected administrative documents, etc.
- Prior involvement in writing post-approval variations for CMC alterations.
- Know-how of EMA and ICH regulatory CMC/Quality regulations suitable across the product life cycle.
- Experience with age-suitable paediatric construction needs and assisting in planning CMC sectors for PIPs.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
