For our customer, Nordic Nanovector a company in the field of targeted therapies for hematological cancers we are looking for a project-based role for a experienced person in the function of
CMC Regulatory Affairs - Radioummunotherapies (m/f/n)
In this function, you will be responsible for assisting in the development of regulatory CMC strategies and activities for the company, including all regulatory submissions. This includes oversight of the development and implementation of global regulatory strategies, ensuring timely preparation, review and submission of documents to regulatory authorities, oversight of the preparation of meeting requests and briefing documents to obtain regulatory advice, collaborating with development partners, and maintaining compliance with applicable regulatory requirements.
- Develop and execute sound and robust global regulatory CMC strategies for targeted biological therapies (naked antibodies and antibody-radionuclide-conjugates)
- Prepare and manage the regulatory CMC documentation of clinical applications (IND and IMPD), CTA/IND amendments, annual reports, health authority briefing packages, and responses to information requests
- Oversee and manage the preparation of Module 3 and 2.3 for BLA/MAAs in co-operation with internal CMC development teams and external service providers
- Provide direction and guidance to the project development team on CMC matters based on relevant regulatory legislation and guidance
- Liaise with Health Authorities for CMC regulatory topics and represent Nordic Nanovector at meetings and interactions with Health Authorities
- Responsible for the regulatory evaluation of CMC change controls including tracking of CMC changes for regulatory submissions
- Track, update and maintain the CMC documentation submitted to health authorities to ensure compliance
- Evaluate and communicate regulatory risks and challenges
- Maintain up-to-date knowledge of regulatory requirements
- Contribute to the SOPs relevant for CMC topics in the Regulatory Affairs department
- MSc in Life or Health Science
- Minimum of 5 years of regulatory affairs experience in the CMC area
- International regulatory experience is required, with experience overseeing major CMC submissions (Modules 3 and 2.3).
- Excellent interpersonal, oral, and written communication skills incl. presentation skills
- Excellent judgement and strong decision-making capabilities.
- Demonstrated ability to work in a dynamic environment with a high degree of flexibility
- Willing to be hands-on and does not delegate responsibilities
- Proven ability to meet aggressive time frames
- Ability to successfully prioritize competing and voluminous work streams simultaneously
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Simone Mumbauer, PhD (+41 44 225 41 12).
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