Nordic Nanovector's mission is to extend and improve the lives of patients with haematological cancers by developing and commercialising innovative antibody radionuclide conjugates (ARC).
Nordic Nanovector is committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The Company aspires to become a leader in the development of targeted therapies for hematological cancers. Nordic Nanovector's lead clinical-stage candidate is Betalutin®, a novel CD37-targeting antibody-radionuclide-conjugate designed to advance the treatment of non-Hodgkin's lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 29 billion by 2026. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
Nordic Nanovector was established in Oslo in 2009 and since March 2015 is listed on the Oslo Stock Exchange.
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Director CMC Regulatory Affairs (m/f/n) - Radioimmunotherapies
Reporting to the Vice President of Global Regulatory Affairs, the Director of CMC Regulatory Affairs 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.
Key responsibilities include:
- 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
What we are looking for:
- Degree in a scientific discipline or health sciences field with a minimum of 5-8 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 judgment 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
LOCATION AND REPORTING LINE
The position reports to the VP Global Regulatory Affairs and will be located in Zug/Switzerland (preference) or in the UK. The position may be partially home-office based. Flexibility to travel is required. Nordic Nanovector offers a challenging and exciting role in one of the most innovative pharmaceutical companies in the field of radioimmunotherapy.
Level of compensation will reflect experience and qualifications.
We pride ourselves on our dedication to our mission to extend and improve the lives of patients with hematological cancers, and it is important to us that all members of our team are connected to this purpose.
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For further information about this permanent position please contact our recruitment partner at Kelly Science, Consultant Jacquelyn Diamond tlf: +47 969 07 226.
Independent contractors with relevant expertise are encouraged to take contact regarding short-term opportunities with Kelly Business Partner Barbara Johnsen tlf: +47 926 39 767.
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