Associate Director Regulatory Affairs to Affibody AB
Do you want to be part in a growing and evolving company developing next generation biopharmaceuticals?
Affibody AB is a Swedish biotech company focused on developing next generation biopharmaceuticals based on Affibody AB’s unique proprietary technology platforms: Affibody molecules and Albumod. The platforms have been developed within the company since 1998 which has resulted in more than 150 granted patents and 30 patent families. Affibody AB is at a strategic inflection point as the company is maturing from a pre-clinical to a clinical stage biopharmaceutical company. The pipeline currently consists of more than 10 proprietary and partnered products in multiple indications. Two therapeutic products are in clinic since 2016 and several more will enter during the coming years.
We are now searching for an Associate Director Regulatory Affairs. You will develop and manage the regulatory affairs aspects of Affibody’s own pharmaceutical projects to successful and timely decisions and deliveries from IND enabling studies to commercialization, primarily via partners. The position will be the only regulatory resource and will report to the CSO.
The Associate Director Regulatory Affairs will be part of the development team, and will be directed by the objectives and demands of preclinical and clinical projects, including developing the regulatory documents needed for the clinical translation of our projects.
Your key areas of responsibility will be:
- Responsible and accountable for delivering analyses, documentation packages and recommendations to the project, or research management, within specified timelines
- Production of IB, IMPD, ODD, and briefing documents for meetings with the regulatory agencies
- Plan and conduct of meetings with regulatory agencies
- Independently plan and execute tasks to meet specified timelines and objectives
- Keep up to date within the regulatory area, including new guidelines
- Aid in the development of Affibody AB''s internal regulatory strategies
You will have an advanced degree in Life Sciences combined with several years of relevant experience from regulatory processes including leading and managing regulatory aspects in clinical projects. You also need to have experience from hands-on work with IND/CTA submissions, interactions with regulatory agencies and regulatory strategic advice, as well as medical writing and development of other relevant regulatory documents. It will be an advantage if you have experience from work in early clinical development programs (first-in-man and phase I/II-studies) and orphan drug designations (ODD).
Affibody AB is cooperating with tthe recruitment agency Aktivia Science Work AB in this recruitment. Please call Knut Natt och Dag on +46 722 16 68 00 if you want more information or want to discuss this recruitment project. Send your application containing a personal letter and CV to email@example.com. Write “Associate Director Regulatory Affairs” in the subject field. We are working continuously with this recruitment project and would like to have your application as soon as possible.
Aktivia Science Work AB is a recruitment agency within Life Sciences. We are members of SwedenBIO and Medicon Valley Alliance. You can read more about us on our website – www.aktivia.se.