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
Clinical Regulatory Affairs (m/f/n)
In this function, you will be responsible for assisting in the development of clinical regulatory 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.
- Provide regulatory guidance and strategy including identifying and assessing regulatory risks and challenges for clinical activities
- In collaboration with CROs and internal clinical development teams, oversee and assist in the preparation of the regulatory documentation of clinical trial applications (IND and IMPD), CTA/IND amendments, annual reports, health authority briefing packages, and responses to information requests
- Oversee and manage the preparation of Modules 5, 2.5 and 2.7 for BLA/MAAs in co-operation with internal clinical development teams and external service providers
- Manage and contribute to the preparation of global regulatory documents such as Orphan Drug Designations and Expedited Pathway Designations (Fast Track, Breakthrough Therapy, PRIME and Adaptive Licensing)
- Lead a cross-functional team to prepare for major health authority interactions (e.g. FDA pre-NDA/BLA, EOP2 meetings, advisory committee meetings and/or EU oral explanations/ scientific advice etc)
- Work cross-functionally with internal departments, including clinical, and third parties on Regulatory Affairs related issues
- Maintain up-to-date knowledge of regulatory requirements
- Contribute to the SOPs relevant for the Regulatory Affairs department
- PhD with focus in Pharmaceutical Sciences or a technical field along with 5+ years of experience in Regulatory Affairs
- International regulatory experience is required, with experience overseeing major clinical submissions (Modules 5, 2.5 and 2.7)
- 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 prioritise competing and voluminous work streams simultaneously
The position is project-based and thus limited for 6 months.
The position may be partially home-office based. Flexibility to travel is required.
Please apply online. For further information about the position, please contact your Kelly recruiter, Mrs Simone Mumbauer, PhD (+41 44 225 41 12).
We connect people to jobs in ways that enrich lives. Kelly Services® is a leading global provider of human resources solutions, operating in over 40 countries. Together with its subsidiaries, Kelly offers a wide range of outsourcing and consulting services; temporary, permanent and management positions as well as flexible forms of employment at all hierarchy levels. Kelly Services (Schweiz) AG has been present in Switzerland since 1979 and counts more than 200 employees in over 40 Talent Offices and Centers.