About the role
In September 2023, Owkin opened its first wet laboratory to generate novel knowledge, allow it to validate hypotheses (target, pathway, mechanism of action related) and reinforce its commitment to understanding complex biology.
Owkin is now looking to establish itself as a fully-operational biotech company and seek to structure its activities in this field. Therefore, Owkin is looking for a Director or Head of Regulatory Affairs in relation to the biotechnological products it develops.
The Director or Head of Regulatory Affairs will be responsible for the formulation and implementation of regulatory strategies and will lead the process in the development of regulatory submissions, including but not limited to: CMC regulatory strategy, risks, and overall plans, to support clinical trial applications, scientific advice, orphan designation, FDA/EMEA MAA including accelerated and conditional approvals leading to successful registration and life-cycle management of unique therapeutic products serving patients with unmet medical needs,
As the Director or Head of Regulatory Affairs, you will proactively identify new regulatory trends and challenges and predict the effect of changes on regulations, policies and procedures. You will conduct due diligence and develop risk management solutions, build collaborative relationships with key stakeholders and manage the internal and external teams responsible for delivery.
In particular, in this role, you will:
- Lead the development and implementation of global regulatory strategies for product development and approvals,
- Identify regulatory risks and develop market-standard strategies to mitigate such risks,
- Serve as Owkin’s main contact with Regulatory Agencies,
- Oversee the preparation and timely submission of regulatory documentation in support of Owkin’s R&D programs (relating to new clinical trial application submissions; pharmacovigilance, marketing authorisation applications, biosamples use, import or export etc.),
- Manage effective submission of additional documentation and information in a timely manner including requests for information, meeting briefing books, meeting minutes, in respect to IND/IMPD/CTA/MAA submissions.
- Develop and implement Owkin’s regulatory compliance program in conjunction with QA,
- Provide regulatory expertise and guidance, including for CMC activities, to internal stakeholders
- Develop and implement internal guidelines and procedures, to ensure compliance with applicable regulatory requirements in conjunction with QA.
- Monitor and interpret new regulatory requirements, including for CMC, Laboratory etc, assessing impact on research activities and development programs
- Train key stakeholders on regulatory requirements.
About you
Required qualifications / experience:
- Advanced degree (or equivalent) in scientific discipline (including but not limited to Pharmacy, Medicine, Chemistry, Biological Sciences).
- Significant experience of regulatory affairs in the biotechnology and/or pharmaceutical industry, with robust knowledge of regulatory frameworks for US, EU and the UK, with demonstrated ability to deliver high quality Regulatory documents and a thorough understanding of the drug development process.
- Hands-on experience successfully preparing and filing IND/CTA/IMPD/MAA within timelines; global submission experience required.
- Ability to both define and execute a global regulatory strategy, balancing high-level planning with direct involvement in regulatory submissions, interactions and compliance activities.
- Demonstrated ability to adapt to changing regulatory landscapes and proactively address regulatory challenges.
- Outstanding written and oral communication skills in English; comfortable communicating with and building relationships with various stakeholders including external partners and regulatory authorities.
- Willingness to travel internationally, as required.
Other beneficial skills and experience include:
- Having supported the development and registration of small molecules and Immuno-Oncology drug products.
- Understanding of AI-technologies in relation to pharmaceutical development is highly desirable.
- CMC/Quality aspects for development of investigational products with FDA expedited regulatory development pathways is highly desirable.
- Expertise in regulatory frameworks for Japan, China, Korea, Australia and Canada is desired but not required.
- Regulatory affairs certifications (RAC, TOPRA) or equivalent are highly desirable.
- Biologics License Applications (BLAs) experience or exposure is desired but not required.
Please submit your application in English
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