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Regulatory Affairs Manager

Employer
Proclinical Staffing
Location
Switzerland
Salary
Negotiable
Start date
20 Aug 2019
Closing date
3 Sep 2019

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

An internationally recognised pharmaceutical company is advertising a vacancy for a Regulatory Affairs Manager, based in their Swiss office. The organisation manufactures and markets innovative pharmaceuticals in novel drug delivery forms. This is an exciting opportunity to join an establishment that works in emerging markets across the globe.

Job Responsibilities:

  • Implementing the global regulatory needs during the development and lifecycle of the assigned products.
  • Implementing the global regulatory needs during the development and lifecycle of the assigned products.
  • Advising project teams in registration questions with focus on regulatory strategy, but also in terms of e.g. preclinical and clinical aspects in collaboration with the specialists of the line functions (Medical Affairs, Marketing, Clinical Development, Commercial Operations, and Supply Chain).
  • Interacting with regulatory agencies and is the regulatory representative for Switzerland and EU region; further countries may be applicable dependent on the product.

Skills and Requirements:

  • Master's Degree in Pharmacy, Chemistry, Biology or another life science.
  • More than 5 years of experience in pharmaceutical industry, preferably in international regulatory affairs.
  • Proficiency in European legislation and ideally also CH, FDA regulations, policies, procedures and respective guidelines.
  • Hands-on experience in evaluation of change control requests.
  • Experience with creation, review and finalization of MA applications as well as variation packages for CH.
  • Ability to drive the regulatory process with a sense of urgency, as well as effectively communicate and negotiate with regulatory authorities.
  • Fluent in writing and negotiation in German and English. Know-how in further languages is of advantage.
  • Good understanding of database and document management systems (docuBridge).
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Alex Czuprynski at +44 203 869 2329 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-AC1

#RegulatoryAffairs

Company

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Company info
Website
Telephone
0800 988 4437
Location
Eldon House
Eldon Street
London
EC2M 7LS
United Kingdom

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