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 RA Development department with the registration of new medicinal products of the commercial product portfolio.
Your main responsibilities include:
- Planning, preparation, procedure management and process ownership of new marketing authorizations in EU, Switzerland and UK, for assigned products to support Business development and Out-licensing. Willingness to overtake potential international submissions for marketing authorizations when needed.
- Timely preparation and compilation of high-quality submission dossiers and direct submission to health authorities.
- Track and monitor queries/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.
- Serves as a regulatory liaison in collaborative projects with other companies.
- 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.
- Accountable for budget forecasting and tracking of the regulatory associated costs in collaboration with finance department.
- Performs other related duties as assigned.
- 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.
- Extensive experience in new submissions in EU, Switzerland and UK and independently running DCP/MRP procedures. Experience in centralized procedures as advantage. Experience in submissions in emerging markets is advantage.
- In-depth knowledge of regulatory requirements, processes and pathways in EU, Switzerland and UK.
- 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.
- 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.
- Willing to work according to the strict regulatory deadlines.
- Excellent command of English; German 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.