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.

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 

Regulatory Affairs Manager

Key Responsibilities:

• Support in preparation/review/ authoring of regulatory documentation and compilation of dossiers for regulatory submissions (IND/CTA, scientific advice, orphan drug designation, fast track designation, breakthrough designation, etc.)

• Lead continuous improvement of the Regulatory Pharmacovigilance system

• Responsible for safety management across studies, review of safety management plans, overseeing CROs on AEs case processing and reporting to regulatory authorities, global compliance, inspection readiness, quality management, pharmacovigilance training

• Responsible for the coordination of Development Safety Update Report’s (DSUR) preparation, IND updates coordination etc.

• Identify and implement process improvements required for compliance with Clinical Trial Regulation (CTR) readiness

• Oversight of CROs in regarding to CTR increased notifications requirement and documentation redaction

• Support quality, regulatory and other personnel outside of clinical function in the company as required

• Analyzing and communicating current regulatory guidance and regulations, as well as industry and regulatory agency best practices and trends

Required:

We think you have an BA/BSc level in relevant life science discipline together with at least 5 years regulatory affairs and pharmacovigilance experience in the biotech or pharmaceutical industry. 

You enjoy creating and participating in an efficient cross functional working environment. You need to have good technical writing and editing skills. Working knowledge of Regulatory and Patient Safety legislation, worldwide, and standard documentation/ document types including understanding of GDP, GVP are important together with relevant experience of PV within the pharmaceutical industry.

As a person you are highly organized, proactive, detail oriented and responsible person. You are an experienced communicator and facilitator, proficient in written and spoken English. To succeed in this position you need to be an effective time manager with good organization and problem-solving skills and to be proficient in MS Word, Excel, Power Point and Outlook.

Personal Profile 

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!

The position is office based in Lund. However, the position may also offer a flexible working arrangement.

Application

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, you are welcome to apply for the position! 

Please send in your application, CV and personal letter, as soon as possible, at latest the 29^th of May 2022.

BioInvent has a collective agreement and contact persons for the Unions are Matilda Rehn, Akademikerföreningen and Jenny Nilsson, Unionenklubben