Norgine sucht Regulatory Affairs Executive (m/f)
Norgine is an independent pan-European speciality pharmaceutical company, established in 1906. We operate in three therapy areas – gastroenterology, hepatology, critical and supportive care. Norgine is a medium-sized company with short decision-making processes characterized by a cooperative leadership and team-oriented working style.
For our office in Vienna with starting date 01st November 2014 we are looking for a
Regulatory Affairs Executive (m/f) – Austria and Switzerland
Full time, 38,5 hours/week, fixed term for 14 months; extension possible, reporting directly to Regulatory Affairs Manager Germany, Austria and Switzerland –
The Regulatory Affairs Executive is responsible, under supervision, for preparing high quality documentation for straightforward regulatory submissions; liaising with relevant departments to ensure regulatory requirements for these submissions are met; communicating with regulatory authorities in order to expedite approval of these submissions with guidance or assistance as required.
- To prepare and submit, under supervision, high quality documentation for straightforward regulatory submissions, following current best practice standards
- To liaise with relevant internal departments and external contacts to ensure regulatory requirements for these submissions are met and to communicate with regulatory authorities in order to expedite approval of submissions, both independently and as directed by line manager
- To prepare and maintain, under supervision, product labelling for appropriate markets in cooperation with local regulatory and commercial contacts
- To resolve straightforward regulatory issues and to assist in the resolution of more complex issues under supervision
- To participate as appropriate in project teams
- To guide and manage direct reports, if applicable
- To prepare draft plans for submissions within agreed timelines
- To identify and provide information for incorporation in the Regulatory databases as appropriate
- To provide information on expenditure against budget for inclusion in periodic financial reports
- To maintain the paper and electronic filing systems for assigned products/countries, following Records Retention procedures
- To interact with industry trade associations and external consultants as necessary
- Good university degree in a relevant life science subject or equivalent
- Well-developed regulatory experience and general knowledge of worldwide regulatory requirements (including GMP, GLP and GCP)
- Working experience and good knowledge of EU and Swiss regulatory environments
- A full strategic understanding of the drug development principles and processes
- Awareness, understanding and an ability to interpret the ICH guidelines relevant to his/her technical/functional responsibilities, specifically those related to developing a Target Product Profile and delivering a product at the end of the development process
- Experience in regulation of medical devices considered an advantage
- Awareness of external regulatory environment
- Demonstrates a good ability to analyse and summarise data
- Focuses on customer needs, follows up on commitments and requests
- Good interpersonal skills
- Excellent verbal and written communication skills
- Works cooperatively within a team
- Able to work effectively without supervision, very good self-organisation skills
- Excellent command of spoken and written English and German
- Results-orientation, reliable and motivated
- Commitment to detail, thoroughness
- Very good understanding of Microsoft Office (Word, Excel, PowerPoint)
- The role requires occasional travel as and when necessary within Europe
You will be part of a very experienced pan-European team, where we believe our skills, experience and resources can improve patients’ lives. Collaboration is a way of life for us. As One Norgine, we are dedicated to working with each other and with our stakeholders. Inventiveness, flexibility and teamwork are at the heart of what we do. It is what makes us different.
Our philosophy is to invest in people who have a high level of qualification, who are open to change and who are willing to work with passion and high commitment. Furthermore we offer an attractive compensation package based on collective agreement of employees in trading firms (salary table A, occupation group 5, salary area Vienna) and a pay for performance approach beyond that. We enable every staff member to contribute to the success of the company.
Do you want to apply?
Please contact Annika Müller in our German office for more information at the following number 0049 6421 9852 – 85 or address your application by email to firstname.lastname@example.org.
Im Schwarzenborn 4