Senior Specialist Regulatory Affairs 100% (f/m/d)
Zurich / Oerlikon, International/Corporate
Acino is a Swiss pharmaceutical company, leader in advanced drug delivery technologies. 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 provide 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.
We are currently looking for a highly motivated and qualified Senior Specialist Regulatory Affairs to support the International RA department with the registration of new medicinal products and with regulatory life cycle activities of the commercial product portfolio.
Your main responsibilities include:
- You will have global responsibility for assigned medicinal products.
- Planning and procedure management of new marketing authorizations, renewal and variation applications for your assigned products.
- Timely preparation of high-quality submission dossiers and direct submission to health authorities, where possible.
- Tracking and monitoring of deficiency letters, commitments from/to Regulatory Competent Authorities and other relevant authorities to ensure that these are implemented and conformed to in a timely manner.
- Review of dossier sections with focus on the compliance to regulatory requirements.
- Direct interaction with regulatory authorities during all stages of the submission preparation, assessment process, up to the approval of submitted regulatory documents, where possible.
- Update of Acino’s Regulatory Information Management System.
- Update of regulatory authority databases, as required.
- Preparation for and participation in meetings with internal and external stakeholders.
- Evaluation of the regulatory environment.
- Provision of internal advice and regulatory information to ensure product compliance.
- Degree in biomedical sciences (Human Medicine / Pharmacy / Veterinary Medicine / Pharmaceutical Sciences) or Chemistry.
- Minimum five years of work experience in a Regulatory Affairs role in the pharmaceutical industry or at regulatory authorities.
- In-depth knowledge of regulatory requirements, processes and pathways in global markets.
- In-depth knowledge of the life cycle management of pharmaceutical products, preferentially generic products.
- Experience in working in project teams or leading regulatory projects.
- Experience in interacting with health authorities as an advantage.
- Experience in the compilation of eCTD sequences and direct submission through health authority webportals as advantage.
- Ability to interact effectively with a diverse group of people from different functions, of different nationalities and at different levels within the company or external business partners.
- Excellent command of English and German; German as native language is an advantage.
This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future.
Execution, Accountability, Multiplier, Growth Mindset and Explicit are Acino Behaviors.
If this sounds exciting, we look forward to hearing from you!
Please send your application documents in English.
Only direct applications are considered. No agencies please.
Our team is happy to respond to any questions about the role or Acino you may have:
We are looking forward to hearing from you.
Only direct applications are considered.