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Director Regulatory Affairs Pharma EU

Employer
Veristat
Location
Switzerland, Germany, Austria, Remote
Salary
Excellent salary & Benefits
Start date
23 Nov 2022
Closing date
23 Dec 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Director/Executive
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Job Details

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

 

SFL Group 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 a Director Regulatory Affairs Pharma EU located in Switzerland

 

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 Coaching junior team members

 

Qualifications and requirements

  • Master/PhD in Pharmacy, Life Sciences or equivalent 10+ 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 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; additional languages welcome

 

SFL offers

  • A stimulating role in an award-winning company (Great Place To Work) 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.

 

Company

Veristat is a scientific-minded global clinical research organization (CRO) focused on therapeutic development in North America, Europe, and Asia/Pacific. With more than 27 years of experience in clinical trial planning and execution, Veristat is equipped to support any development program. 

Veristat supports regulatory strategy, clinical trial design and implementation, data analysis, and preparation of marketing applications. We have assembled an extraordinary team of experts who specialize in supporting biopharma in developing the most complex, novel, rare, and advanced therapies.

 At Veristat, culture and fit are just as important as skills and experience. We believe that the work we do, and the values we do it with, are critical to bring new therapies to market to save and extend lives. 

Veristat supported clients in preparing marketing applications for 12% of the 2021 U.S. Food and Drug Administration (FDA) novel drug approvals. 

Find Us
Location
27 Old Gloucester Street
London
WC1N 3AX
GB
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