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
Senior CMC Regulatory Affairs Manager
As our Senior CMC Regulatory Affairs Manager, you will plan, author and manage the assembly and timely submission of CMC related documentation for EU, US and RoW such as Module 2 and Module 3 CTD documents and IMPDs filings of new drugs.
The role will provide strong support and guidance to cross-functional teams (across multiple projects), as well as Technical Operations in global regulatory CMC requirements to assure compliance. You will also support other departments in Technical Operations, QC and QA with activities related to regulatory compliance and improvements on procedures.
You will report to Director Regulatory Affairs.
The main responsibilities are as follows:
• Work cross-functionally to develop CMC regulatory strategy in line with overall regulatory strategy across projects and company project goals.
• Responsible for coordination, development and authoring of high-quality regulatory documentation, in particular but not solely CMC dossiers for regulatory submissions (IMPDs/INDs, Module 2 and 3 for MAAs and BLAs) and lead response preparation on Health Authority requests for information.
• Ensure maintenance of regulatory compliance, conformance of internal quality procedures and provide training to internal stakeholders with guidance on impact of new regulatory and scientific regulations.
• Leverage both technical and scientific knowledge to conduct appropriate analysis, mitigate risks and evaluate opportunities for regulatory innovation within projects
• Support the preparation and execution of Health Authority meetings, meetings with consultants, and external partners.
• Assist in overseeing and supporting regulatory submissions other than CMC-related, when necessary.
To succeed in this role we require that you have a relevant Bachelor's Degree plus 10+ years of experience in pharmaceutical industry. You have working knowledge of EMA, FDA and ICH regulatory guidance and regulations, with focus on regulatory Chemistry Manufacturing and Control (CMC) or with regulatory expertise in pharmaceutical science development and manufacturing. Experience with biological products would be highly advantageous as well as track record of authoring IMPDs and IND Module 3 documentation.
You need to have the ability to interpret and apply global / regional CMC regulatory requirements for assigned portfolio and a good level of knowledge and solid understanding of the development and (Current) Good Manufacturing Practices (part of GxP) required to assess technical, scientific and regulatory merits of CMC information, commitments and data to lead teams and/or project(s).
Other requirements are in-depth knowledge in technical writing and electronic working tools, a clear track record of effective teamwork, collaboration, and an open communication together with good planning/organizing by prioritizing ability. Proficient in written and spoken English.
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 while securing high quality deliverables. You are enthusiastic and enjoy creating results and achieving goals both individually and together with your teams.
The position is office based in Lund. However, the position may also offer a flexible working arrangement.
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!
Please send us your application, personal letter and CV and tell us why you are the right person for this new position, at the latest 1st of September 2022.
BioInvent has a collective agreement and contact persons for the Unions are:
Matilda Rehn, Akademikerföreningen and Jenny Nilsson, Unionenklubben