Newly combined with Baxalta, Shire is now the leading global biotechnology company focused on serving people affected by rare diseases and highly specialized conditions. Our 22,000 employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Company Insights https://youtu.be/ly_8oO-iJeU
The EU Regulatory Product Specialist will have to manage all product registration within Europe and provide technical support for the assigned products in Europe, Middle East & Africa and the Americas/Asia.
Specifically for the assigned products the position has the responsibilities under general supervision of the Senior Manager for the following activities:
- Support for regulatory activities for projects for the assigned product
- Support for discussion and development of regulatory strategies together with the regional (country) RA function, project groups and line function as appropriate
- Preparation of technical information and correspondence for contact with health authorities on regulatory projects and particular issues within the product responsibilities in agreement with Senior Manager
- Communication and coordination of actions with RA LCM Middle East & Africa and the Americas/Asia as well as country-based RA units in agreement with the Senior Manager
- Support of team members of the respective projects within the therapeutic groups
- Support for evaluation of change controls for their impact on European licenses
- Follow-up of compliance issues and elevation to line function
- Provision of manuscripts of labeling material and review of final printed labeling in agreement with the Senior Manager
- The jobholder stands in for team members in the same therapeutic area
- Bachelor?s degree or country equivalent in pharmacy or related scientific discipline higher degree/PhD will be a strong advantage
- Broad scientific knowledge and interest
- A minimum of 2-4 years experience within a pharmaceutical company, CRO, or similar organization, preferable in Regulatory Affairs environment
- Knowledge of regulations
- Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- Proofreading and editing skills
- Ability to contribute to multiple projects from a regulatory affairs perspective
- Ability to multitask and prioritize
- Written and Verbal communication skills in English and German
Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is € 3,008.38 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field. Company Insights: https://www.youtube.com/watch?v=Ke-L4TZOujs