Senior Manager Regulatory Affairs 80-100%

Gefunden in: beBee S CH - vor 4 Wochen

CH Basel SFL Regulatory Affairs & Scientific Communication GmbH Teilzeit

Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry?

SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from vibrant start-ups to established top 10 pharma and medtech companies.

We have an opening for an experienced Senior Manager Regulatory Affairs located in Switzerland or EU.

Core responsibilities

· Leading regulatory activities on assigned projects

· Develop and lead regulatory strategy

· Ensuring regulatory compliance of assigned projects

· Independent preparation of regulatory dossiers

· Interactions with Health Authorities

· Interactions with client contact persons

Qualifications and requirements

· Master/PhD in Pharmacy, Life Sciences or equivalent

· Minimum of 5 years regulatory affairs experience in consulting or pharmaceutical industry

· Hands-on experience and sound understanding of the regulatory processes

· Analytical and systematic thinking, organization, business orientation and flexibility

· Experience with early development projects, including PIPs, ODDs, authority meetings and MAAs under the centralized procedure

· Global regulatory experience, or experience with Swiss Regulatory is a plus

· Able to work independently and on own responsibility under pressure

· A highly motivated and open minded personality, able to work in an international environment

· Excellent communication skills

· Fluent in English; German or additional languages welcome

SFL offers

· A stimulating role in a growing and dynamic organization

· Work in an international, energetic, motivated team

· Continuous development and training opportunities

· Office- or home-based working

· Rewards for outstanding accomplishments

About SFL

We provide innovative and customized services and solutions in the field of life sciences from offices in Switzerland and the EU. Our main areas of expertise are Regulatory Affairs, Medical Affairs, Quality Assurance & Supply Chain, Market Access, Public Affairs, Pharmacovigilance, and Legal & Compliance.

Expertise, innovation, development, respect and ethical behavior are our values and corner stones of our company culture and key to our success and excellent reputation. We are a rewarding company with an excellent environment to grow.

If you are interested in this position, please share with us your application with CV, motivation letter and references here.

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