Regulatory EU Manager job in Zürich, Switzerland

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Contract

Discipline: Project Manager

Location: Switzerland

This vacancy has now expired. Please see similar roles below...

Proclinical are recruiting for a Regulatory EU Manager to join a pharmaceutical organisation. This role is on a contract basis.

Responsibilities:

Supervise and be responsible for working with any other RA functions and/or vendor to guarantee that regulatory proposals are completed on schedule in area of accountability.
Handle, plan, and implement regional regulatory proposals in area of accountability and assure approvals throughout product development and lifecycle are completed in a timely manner.
Oversee and notify developing trends, guidelines and changes, with emphasis on those linked to area and location of accountability.
You might need to offer guidance to senior management as seen fit.
Work alongside international colleagues, work to resolve crucial conflicts within international regulatory methods.
Write and supervise implementation for more multifaceted regional regulatory methods as required.
The ideal candidate might be needed to guide and supply regional contributions in due diligence for licensing prospects, development and/or marketed products.
Guarantee coverage of projects in the therapeutic area recognises possible gaps and suggest solutions to management.
Responsible for presenting regional regulatory methods to senior management when suitable.
Any other assigned duties.

Key Skills and Requirements:

Educated to a degree level in a science discipline or similar though an advanced degree would be more ideal.
Familiarity within a pharmaceutical organisation, which involves regulatory affairs experience within development and/or post-marketing phases.
Expertise on guidelines and regulations governing drugs and biologics in development, which involves post-marketing within the EU.
Comprehension of multifaceted scientific concerns across projects and therapeutic areas(s) of accountability as it links to regulatory needs and method.
Acquaintance within handling various filings or various programs simultaneously in connection to development area.
Knowledge of the EU region with international involvement would be ideal.
Communication skills both verbally and in writing,
Able to handle and adhere to timelines.
Deliberation capabilities with integrity and adaptability.
Capable of recognising and resolving issues.
Works well with others both internally and externally of the business.
Ability to take a stand on important concerns in a productive and respective manner.

If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com.

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.

#Regulatory