Director Regulatory Affairs

BioInvent International AB (OMXS: BINV) is a clinical stage company focused on the development of novel, first-in-class immuno-modulatory antibodies for the treatment of cancer, addressing the need for novel treatment options that have the potential to significantly improve patient outcomes. Our powerful discovery engine is based on our validated, proprietary F.I.R.S.T™ technology and our proprietary n-CoDeR® antibody library to simultaneously identify targets and antibodies that bind to these targets, generating many promising new drug candidates to fuel the Company’s proprietary product pipeline as well as for licensing and partnering purposes. More information is available at www.bioinvent.com.
The BioInvent team covers all aspects of drug development, including discovery, preclinical and translational research, manufacturing, and clinical development.
Together we are creating the exciting future of BioInvent, and we welcome you to be part of it – as our Director Regulatory Affairs.
Key Responsibilities
The Head of Regulatory Affairs is responsible for developing and executing global regulatory strategies aimed at identifying and implementing the most efficient regulatory pathways for BioInvent’s current and future drug development programs.
The responsibilities of the position include, but are not limited to:
Developing and formulating BioInvent’s regulatory strategy and policy, ensuring that product manufacturing (CMC), pre-clinical and clinical development plans comply with all applicable regulatory requirements (e.g., global development plan, TPP).
Overseeing the planning and preparation of regulatory submissions to pursue expedited review to facilitate development of BioInvent’s drugs (e.g., IND/CTA, scientific advice, orphan drug designation, fast track designation, breakthrough designation, PRIME) and maintaining these.
Maintaining a high-quality network of service providers and consultants to bring expert critical thinking about regulatory strategy.
Acting as an internal resource for regulatory input on pre-clinical, clinical and product development (CMC) policies.
Planning, coordination and preparation of communications and interactions with regulatory agencies (e.g., scientific advice meetings, pre-IND, IND meetings) including leading the preparation of briefing documents and attending the meetings.
Supporting due diligence and partnering activities, as needed.
Analyzing and communicating current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends, to keep company informed on any relevant changes in the regulatory landscape.
Contributing to corporate development strategies and implementation of a risk-based clinical Quality Management System.
Performing all duties in keeping with BioInvent’s core values, policies, and all applicable regulations.

Requirements
At least 10 years regulatory affairs experience in the biotech or pharmaceutical industry, preferably experience of early phase studies in oncology and /or hematology drug development. Experience with immunotherapies and monoclonal antibodies would be an advantage.
Detailed knowledgeable of European, US FDA pharmaceutical regulations and guidance, drug development process (in addition, knowledge of Chinese environment would be an advantage)
Proven ability to think strategically; managed and solved challenging regulatory issues.
Superior communication skills in cross-cultural environments
Ability to manage complexity and uncertainty.
Excellent business judgment, problem solving skills.
Enjoy creating and participating in an efficient cross functional working environment.
Be flexible, think creatively, and be willing to undertake different approaches.
Practical experience in project management and leadership.
Proficient in MS Word, Excel, Power Point, Outlook, MS Project.
Proficient in written and spoken English.
Excellent presenting skills.

Qualifications
Educated to BA/BSc level in relevant life science discipline.
Desirable: Masters/ PhD/ PharmD in related area of discipline (sciences, clinical, business, project management)


Personal Profile
We are looking for a driven, structured, self-motivated and responsible person, who easily collaborates and communicates with others both verbally and in writing. You have excellent problem solving, and negotiation skills and you enjoy creating efficient working methods and contributing with your experience to ensure continuous improvements.
Personal suitability is of great importance and we believe that you are efficient, have a strong commitment and ability to make things happen. You understand the importance of achieving results, keeping deadlines and to secure high quality within your work. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
To summarize, BioInvent has several value driving factors in place with great potential for the future. If you match the described profile and would like to contribute to important cancer research as a part of BioInvent and our exciting future, you are welcome to apply for the position!
Location
The position is office based in Lund. However, the position may also offer a flexible working arrangement.
Application
Please send your application (CV and personal letter) through our website https://careers.bioinvent.com/
Interviews will be held continuously which means the positions can be filled before deadline. Please make sure to send in your application as soon as possible, at the latest 17 April 2021.
BioInvent has a collective agreement and contact persons for the Unions are:
Fredrik Wiberg, Akademikerföreningen and Jenny Nilsson, Unionenklubben