AOP Orphan is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance our team in Vienna we are looking for a:
AOP Orphan is a European pioneer in the development, marketing and distribution of medicines for people with rare and complex diseases. To enhance our team in Vienna we are looking for a:
Regulatory Affairs Manager (f/m/d)
As part of our Regulatory Affairs team you will play a key role in the submission of new regulatory projects and in the life cycle management of existing licences (EU and non-EU scope).
Regulatory Affairs Manager (f/m/d)
Professional Skills
University degree in Natural Science
3-5-year 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 and German
As part of our Regulatory Affairs team you will play a key role in the submission of new regulatory projects and in the life cycle management of existing licences (EU and non-EU scope).
Ready for an ambitious job?
You are responsible for the preparation and compilation of registration dossiers according to country specific requirements in collaboration with other functions
You coordinate, review and proof-read responses to questions from authorities
You evaluate changes for regulatory impact and filing requirements
Like to take accountability?
You will play a key role in the submission of new regulatory projects and in the life cycle management of existing licences (EU and non-EU scope)
You provide regulatory guidance and strategy to Project Teams involved with the development of new products
Able to align?
You act as regulatory contact person for authorities, external partners and in-house functions
You offer CMC regulatory expertise for proposed changes within life cycle management and during pharmaceutical development activities
You are a team player and like to work cross-functionally and with external partners
Looking for an agile environment?
You prefer working with a high degree of independence and responsibility for assigned projects
You have a pro-active attitude, the ability to develop new concepts and a creative approach to problem-solving
You enjoy working in a high-performing and international company environment
The gross monthly salary provided for this function is a minimum of € 3.500.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
The gross monthly salary provided for this function is a minimum of € 3.500.- based on full-time employment. Any potential overpayment depends on professional experience and qualifications.
Ihr Ansprechpartner
Angelika Drabek
+43 1 503 72 44-62
