REGULATORY AFFAIRS MANAGER (M/F/D)
PHARMA

Our client is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance the Regulatory Affairs team at the Vienna headquarters our client is looking for a Regulatory Affairs Manager (m/f/d).


Responsibilities

  • Responsibility for the preparation and compilation of registration dossiers according to country specific requirements in collaboration with other functions
  • Coordinating, reviewing, and proof-reading responses to questions from authorities
  • Evaluating changes for regulatory impacts and filling requirements
  • Acting as regulatory contact person for authorities, external partners, and in-house functions
  • Offering CMC regulatory experience for proposed changes within life cycle management and during pharmaceutical development activities
  • Being a team player and working cross-functionally and with external partners
  • Playing a key role in the submission management of new regulatory projects and in the life cycle management of existing licences (EU and non-EU scope)
  • Providing regulatory guidance and strategy to Project Teams involved with the development of new products


Professional Skills

  • University degree in Natural Science
  • Minimum 3 years Regulatory Affairs experience in the pharmaceutical industry
  • In-depth knowledge of international regulatory requirements
  • Ability to strategically plan, prioritise, and manage multiple projects
  • Attention to details and ability to deliver high quality regulatory documentation
  • Strong communication skills to liaise with internal and external partners with different cultural backgrounds
  • Full proficiency in MS Office, knowledge of SharePoint and an eCTD publishing tool is a plus
  • Fluent in English; German is an advantage
  • Preferring to work with a high degree of independence and responsibility for assigned projects
  • Having a pro-active attitude, the ability to develop new concepts, and a creative approach to problem-solving
  • Enjoying working in a high-performing and international company environment


The gross yearly salary provided for this function is a minimum of EUR 50,000 (excluding bonus) based on a full-time employment. Any potential overpayment depends on professional experience and qualifications.


We are looking forward to receiving your application addressed to Katrin Spögler, MA quoting reference number E1194 to jobs2@eblinger.at