Regulatory Affairs Manager

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.

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