Regulatory Affairs Manager/QPPv
We are looking for you with a few years of experience working in Regulatory Affairs and / or Quality Assurance, Pharmacovigilance. The position is an important role with varying tasks and a large area of responsibility with the opportunity to influence and develop the role. Here you get the chance to work at a small company that is in an expansive phase, while you get to spend everyday life with a wonderful team with a focus on innovation and patient benefit. The position is full time and the head office is located in Danderyd in Stockholm.
About the service
In the role of Regulatory Affairs Manager / QPPv at FrostPharma, you work closely with the Head of Regulatory Affairs, but also other departments at the company. Your main tasks and responsibilities will be:
Handle complaints and perform self-inspections for tasks performed by the wholesaler
Handle applications to competent authorities such as translations, local variations, notifications, exceptions or the like for products where Frost Pharma acts as a local representative.
Advice in Regulatory Affairs strategies for marketed products, external handling of product information such as handling of catalog texts (FASS, Felleskatalogen, Pharmaca Fennica, etc.).
Assessment of compliance for marketing materials.
Act as QPPv and establish and maintain the drug monitoring system at FrostPharma and be responsible for drug monitoring activities being conducted in accordance with all applicable requirements and regulations.
Receipt, follow-up and documentation of side effect reports in accordance with the local quality system and in accordance with agreements with external partners.
Responsible for ensuring that all employees and contracted consultants involved in drug monitoring activities at FrostPharma regularly receive appropriate training in drug monitoring.
Who are we looking for?
We are looking for you who are independent, structured, unpretentious, driven and thrive in a work environment where changes can come quickly and roles are broadened and developed. To succeed in the role, you must have a relevant scientific education and at least 5 years of work experience in Regulatory Affairs and / or Quality Assurance, Pharmacovigilance. We want to you speak and write fluently in Swedish and English.
According to the agreement
A warm welcome with your application! We interview on an ongoing basis and the position may be filled before the last response date.