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Senior Director Regulatory Affairs

Headquartered in Nijmegen, The Netherlands, Tagworks Pharmaceuticals is a dynamic biotech company with strong backing from prominent US and European investors. Specializing in proprietary in vivo click chemistry, Tagworks is committed to improving the effectiveness and reducing the toxicity of systemic cancer treatments. With operations in The Netherlands and as well as in the USA, Tagworks pioneers unique approaches towards antibody-drug conjugates, prodrugs, and targeted radiotherapeutics through its "Click-to-Release'' platform, rooted in Nobel Prize-winning research. To further strengthen the organization, we are looking for a Senior Director Regulatory Affairs.

The position
Our Senior Director Regulatory Affairs (US-based, remote / on-site) is responsible for the development and implementation of the regulatory strategy for our product candidates, and drives the operational momentum for these programs. You manage and collaborate with CRO partners in the process of planning and preparing for global regulatory submissions. You establish and manage regulatory timelines and serve as a liaison between the company and regulatory authorities for assigned programs. You prepare meeting requests and briefing documents, provide expertise and support to your Tagworks colleagues in advance of meetings/teleconferences with regulatory agencies. You prepare regulatory development plans for programs for US and ex-US. You develop and maintain regulatory knowledge of US, EU and ROW regulations. You coordinate and prepare responses to Regulatory Agency requests for information. You create an interface with CMC, non-clinical and clinical research colleagues and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company. You maintain active INDs/CTAs (amendments and annual reports) and assist in the development of company processes, policies, SOPs and associated documents.

The requirements
You bring 15+ years’ experience in a biotech/pharmaceutical research environment, including 10+ years in US Regulatory Affairs. You have at least a Bachelor’s Degree in a scientific discipline or equivalent but preferably a Master’s Degree or PhD in a scientific discipline. You have experience in the preparation, submission, and navigating FDA review of INDs, BLA or NDA for bio-pharmaceutical products (such as ADCs), preferably in oncology. Besides this, EU regulatory experience is preferred. You have people management experience and you are a team player who can collaborate and work successfully with multiple key stakeholders. You have the ability to handle multiple, competing tasks in a fast-growing company environment. You have strong verbal and written communication skills. You are a highly motivated, resourceful individual who can set goals, shift priorities, work independently and collaborate effectively with project teams. Finally, you have good organizational skills and attention to detail.

The offer
You will join a group of passionate and very skilled professionals working towards a common goal. We offer a set of attractive and competitive benefits, recognizing and rewarding our talented and motivated employees.

Our culture and values
At Tagworks, our culture is built on innovation, collaboration, inclusivity and achieving results. We prioritize teamwork, flexibility, resilience, adaptability, and fulfilling commitments.

How to apply
Please send your CV together with a cover letter to hr@tagworkspharma.com.


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Contact
T +31 85 800 8550
info@tagworkspharma.com

Address
Tagworks Pharmaceuticals BV
Toernooiveld 1
6525 ED  Nijmegen
The Netherlands

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