Loading ...

Job content

On behalf of a fast growing pharmaceutical company I am currently looking for a Regulatory Affairs Professional with hands-on expertise on CMC (min. 4 years of exp.).
The successful candidate will be involved in pre-approval RA and will interact with authorities even in the clinical phase of the regulatory as well.
The company is a pharmaceutical company delivering injectable anesthetics and analgesics to patients worldwide through innovative solutions with excellence in development, production and marketing.
The successful candidate will operate under the direct coordination of the CMC Strategy Manager and in collaboration with the Pharmaceutical Development Team and the colleagues in the Scientific Affairs Department, will follow the project starting from the input, which could be a new product dossier or a change implementation in an approved dossier, until the submission of the complete CMC part (Module 3 and 2.3) or specific sections.

Tasks and Responsibilities:
Collaborations with Regulatory Affairs and Technical Departments to define regulatory CMC strategies and identification of potential regulatory risks.
Identification of the required documentation for CMC submissions and negotiation with the Technical Departments of the approved technical data and documents delivery.
Review of post-approval CMC changes (Change Controls) and assessment of the regulatory impact on the affected dossiers in collaboration with Regulatory Affairs. Definition of the regulatory strategies for variation and preparation of the concerned CMC section.
Collecting the responses to inquiries from Regulatory agencies on CMC content of regulatory submissions.
Preparation of meeting materials and attending to Health Authority advice related to CMC drug development activities and submissions.
Responsible to identify critical CMC/CMC regulatory issues, drive strategies and implementation for their resolution.

Skills and Competences:
Bachelor’s degree in a scientific discipline (Chemistry, Industrial Chemistry, Pharmaceutical Chemistry)
+5 years of experience in scientific/ technical line functions (e.g., upstream/ downstream/ analytical or drug product development)
Experience in eCTD CMC Part (Module 3 and 2.3) compilation and management
Knowledge of EU/US/Swiss regulations related to the eCTD CMC Part (Module 3 and 2.3) and guidelines related to manufacturing equipment, process validation, stability and photostability studies, elemental impurities, extractable & leachable, analytical methods validation.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover.
Loading ...
Loading ...

Deadline: 04-05-2024

Click to apply for free candidate

Apply

Loading ...
Loading ...

SIMILAR JOBS

Loading ...
Loading ...