Head of Regulatory Cmc Medical Device and
vor 10 Stunden
Hobson Prior are currently looking for a Head of Regulatory CMC Medical Device and Combination Products to join a brilliant pharma establishment on a permanent basis. Our client is focused on rare illnesses and offering available novel solution that will change their lives.
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 accountable for daily regulatory CMC actions.
- Evaluate and contribute to ICH, FDA, and EU CMC regulations.
- Any other assigned duties.
**Key Skills**:
- Communication abilities, both written and verbally.
- A high attention to detail with the ability to resolve issues.
- Leadership abilities with familiarity in managing change.
- Applies good judgment in raising and conveying actual or possible problems to appropriate management.
- Works well in a team environment, as well as comfortable operating within a fast-paced organisation.
**Requirements**:
- Educated to ideally an advanced degree level in a life science discipline.
- At least 15 years of experience in a pharmaceutical organisation, which involves at least 10 years of experience in a regulatory affairs CMC leadership position.
- Knowledge in international CMC regulatory and guiding regulatory agencies CMC networking internationally, such as with FDA, CHMP, PMDA, NMPA, etc.
- International regulatory protocols know-how.
- Capable of handling engagements with Health Authorities.
- Able to embody CMC Regulatory to authorities and business management.
- Capable of examine requirement, implement familiarity and evolve resolutions to multifaceted problems, as well as conclude and/or discuss the most suitable course of action in a timely fashion.
- Fluency in the English language.
- Computer literacy in Excel, PowerPoint and Word, with the ability to configuring and having papers prompt for presenting.
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.
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