Associate Director Regulatory Affairs - CMC
When it comes to life-threatening diseases, we are one family. We at Kiadis are focusing our research & development on NK cell therapeutics, leveraging the natural strengths of our immune systems to source the best cells for life.
Would you like to be the pathway between our CMC activity and the Regulatory Authorities to help delivering our amazing work to patients worldwide? Are you a Regulatory Affairs expert with broad CMC knowledge and that is ready to deliver crucial strategic input? Are you a charismatic influencer that effectively manages leadership encounters with a high sense of integrity? Read on.
As an Associate Director Regulatory Affairs - CMC, you are responsible for preparation, review, editing and submission of regulatory documents and liaising with regulatory agencies, and with the focus on CMC. In addition, you are responsible for development of the CMC Regulatory strategy and pathways, and managing development of the Regulatory Affairs plan for the different investigational products. Develop and recommend company policy and position on Regulatory Affairs issues. In your day-to-day you will:
- Represent the Regulatory Affairs department/be the Regulatory Affairs Lead in multi-disciplinary project team meetings.
- Participate in the design of the Kiadis Pharma product strategy.
- Liaise with Regulatory Authorities (FDA, EMEA, Health Canada and/or local competent authorities) on clinical programs, ODDs, marketing authorizations and product compliance issues and ensure that the company’s activities comply with the regulatory requirements.
- Be responsible for the preparation of all CMC related documentation in the regulatory filings
- Be responsible for managing the compilation and submissions of all regulatory filings within established timeframe and schedule by coordinating filing activities between departments and any outside consulting firms.
- Be responsible for vendor selection and vendor management for Regulatory Affairs.
- Ensure that the company’s activities comply with US, European and Canadian, regulatory requirements.
- Support other departments like Clinical Operations, Pharmacovigilance and QA to ensure regulatory requirements are met.
- Maintain current knowledge of relevant regulatory requirements for drugs, ATMP’s and biological products in US, Europe and Canada.
The ideal candidate
We are looking for someone that wants to be part of a dynamic organization, with multidisciplinary team structures and continuous switch of prioritization. It would be great if you have the following requirements:
- MSc, PhD or PharmD in cell biology, immunology, hematology, oncology, biotechnology, or related fields.
- At least 7-10 years of experience in a related field, preferably in regulatory affairs. Experience in the field of cell or gene therapies/ATMPs, and/or orphan drug designations is a plus.
- Familiar with FDA, EMEA, Health Canada and/or competent authorities.
- Strong Regulatory Affairs knowledge on CMC development.
- Strong communicator both with internal and external parties.
- Open to travel up to 10%.
- Flexible as we work across multiple time zones.
- Fluency in English, other languages are a plus.
32 tot 40 uur per week
Minimaal 7 jaar related field, preferable in regulatory ervaring
Je beheerst Engels