Senior Regulatory Affairs Manager (Out-Licensing) (f/m) 100%
Zürich / Oerlikon, International/Corporate
Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technolo-gies. We have a clear focus on selected emerging markets in the Middle East, Africa, the CIS Region, and Latin America, and we operate in some of the most dynamic countries of the world. We value courage, commitment, trust, and empathy and pro-vide an environment that supports initiative and effort. We are proud to be action-oriented and open-minded, with a strong focus on quality and product availability, even in remote and hard to reach areas of the world. For our Out-Licensing Division with focus on Europe we are currently looking for a Senior Regulatory Affairs Manager.
This position is based in Zürich / Oerlikon.
Your main responsibilities include:
- Audit dossiers for new molecules (Modules 2 and 3)
- Assistance in defining regulatory strategy for Europe
- Compile eCTD dossiers for submission in EU together with CROs/partners (new molecules)
- Liaise with regulatory consultants, authorities, customers
- Review contracts with respect to RA matters
- Cross-functional coordination and alignment on OL projects with internal and external stakeholders on a global level
- Follow-up on daily business for existing molecules
- Pro-actively pursuing project related topics and removing project bottle-necks
- Creation and establishment of project plans, timelines, stakeholder matrixes, communication channels and further project tools with internal & external stakeholders
- Ensuring timely execution of Out-Licensing projects
- Ensuring execution of Out-Licensing projects within pre-defined budgets
- Preparing and leading project meetings with internal and external stakeholders
- Reporting the project status to the management
- Minimum educational requirements are a Master’s Degree in Pharmacy, Chemistry, Biology or another life science
- More than 7 years of experience in regulatory affairs specialized in the CMC area and with knowledge of the EU procedures (DCP/MRP/National)
- Experience in pharmaceutical industry preferably in the generics business
- Experience in project management
- Strong expertise in CMC
- Outstanding communication skills
- Ability to work cross-functional in a complex project environment and keeping close track of project activities
- Ability to work in an international business setting
- Scientific/regulatory background
- Experience in pharmaceutical industry is an advantage
- Project Management experience, Project Management certifications and/or MS Project experiences are a very strong advantage
- Business mind-set & customer focused
- Pro-active work attitude
- Willingness to take on full ownership of projects
- Ability to stand difficult discussions internally and with stakeholders
- Experience in reporting and presenting to senior management is a plus
- Organized & structured work approach
- Ability to work under pressure and with tight timelines
- Fluent in German and English
- Experience with office 365 applications, docuBridge and drugTrack is a plus
This is the opportunity to join a very dynamic organization, where decisions are tak-en fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you! Please send us your complete ap-plication to – preferably via e-mail into one PDF document – to Ms. Emmanuelle Leblanc.
HRBP & Talent Acquisition
We are looking forward to the opportunity to get to know you.
Only direct applications are considered.
Apply & Further Information
To apply we invite you to send your application along with all pertinent documents – preferably via e-mail in one PDF document – to our HR team through the email listed below. The team is also happy to respond to any questions about the role or Acino, that you might have.
We are looking forward to hearing from you. Only direct applications are considered.Job list