home news about team portfolio careers contact pharma& careers We are hiring! Regulatory Affairs Manager Biologicals, marketed products Full Time or Part Time pharma& (www.pharmaand.com) is a privately owned company, aiming at satisfying needs for niche, original, Specialty Care products that offers and develops original prescription medicines for specialists worldwide and is constantly growing through strategic acquisitions. pharma& relies on an established network for the production and distribution of its products. The headquarter of the company is located in Vienna, Austria. The company is managed by its two founders and a team of experienced experts who aim to ensure the long-term availability of established originator products in specialty medicine, to supply them worldwide and to develop them further for the benefit of current and future patients. Having recently acquired with the worldwide rights of Pegasys (peginterferon alfa 2a) our first biological product we are building up our regulatory team, preferably located in Vienna and/or Zug (Switzerland). In order to perform the upcoming MATs and post marketing regulatory activities worldwide, we are looking for Regulatory Affairs Managers for the territories Europe, US and Row, who are attracted to join a team of highly motivated, self-driven and results-oriented individuals working together to secure long-term supply. Main responsibilities: You will be responsible for the execution of all regulatory tasks for your allocated region with the purpose to ensure rapid and timely regulatory approvals and maintenance on the market. Assess, prepare and submit marketing authorisation applications (incl. e-CTD); mainly variations (life-cycle management) Ensure regulatory compliance (change control etc.) and maintenance of existing marketing authorisations Drive regulatory processes to ensure timely approval Follow-up and implement new regulatory requirements (regulatory intelligence) Maintain all regulatory related databases and information systems in line with internal policies and SOPs Coordinate and manage labelling & artwork processes Act as the point of contact for all regulatory related topics (authorities incl. EMA, external and internal stakeholders etc.) Build and maintain good communication and collaboration with authorities as well as external partners and internal departments (quality, PV, manufacturing, supply etc.) Provide regulatory input into selected internal and strategic projects as required Support regional regulatory affairs (outside Europe) as required Role requirements: University Degree (ideally Master of Science degree) or equivalent Fluency in English and German (written and spoken), other languages are an advantage Proven track record and relevant international experience in drug regulatory affairs incl. experience with regulatory authorities; experience in biologicals is an asset Pragmatic team player with good communication and organisational skills Reliable, accurate, dynamic, highly self-motivated and result-driven personality Good IT and administrative skills What you can expect of us: Fast-growing company in an International environment Results oriented and owner driven entrepreneurial company spirit People centric, dynamic teams with flat hierarchies High operating freedom promoting individual accountabilities Competitive compensation in line with the market standards We are looking forward to receiving your application at career@pharmaand.com ! © 2021 by pharma& IMPRESSUM