Senior Regulatory Affairs Manager

Employer
Hobson Prior
Location
Switzerland
Salary
£58.30 - £66.63 per hour
Closing date
30 Sep 2020

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Contract
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Hobson Prior are looking for a Senior Regulatory Affairs Manager to join world-wide pharmaceutical organisation who are determined to bring better health to patients. This position will be based in Zurich.


Job Responsibilities:

In charge of supporting the regulatory activities related to the development, registration and life cycle management of vaccine candidates in Europe.

Manages given regulatory projects including support of dossier/MAA submissions and life cycle management for vaccine candidates in the region.

Ensures that all essential applications are filed and upheld in compliance with applicable regulations.

Provides regulatory operational support for allocated projects, focused on non-clinical and clinical aspects of drug development/approval and associated regulations.

Responsible for regulatory oversight of given clinical trials conducted in the region.

Works together with all regulatory counterparts to ensure configuration and completion of the global regulatory strategy for the assigned projects.

Leads and directs the work of others as part of a matrixed organization.

Key Skills:

Capability to understand and interpret scientific issues across projects.

Pays strong attention to quality and is working reliably and thoroughly.

Strong in all basic skills sets such as oral and written communications (in English), managing and adhering to timelines, negotiation skills, integrity and adaptability.

Exceptional in working and communicating well with others.

Proactively identifies regulatory issues.

Offers creative solutions and strategies, including risk mitigation strategies as applicable.

Requirements:

Educated to a minimum of degree level, BSc- advanced scientific degree preferred.

A minimum of 6 years pharmaceutical industry experience.

At least 4 years regulatory experience.

European regulatory experience is essential.

Preferred experience in managing filings to EMA via Centralised Procedure resulting in first-time approval.

Vaccines and/or biologics experience is advantageous.

Prior participation in Global regulatory filing is beneficial.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Contact Us
  • Wellington Gate
  • 7-9 Church Rd
  • TN1 1HT
  • GB
  • 01892 612 612
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