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Regulatory Affairs Project Manager (M/F)


06.05.2021 | Grande Lisboa | Referência: 2018488


Regulatory Affairs Project Manager (M/F)

Grande Lisboa

Your new Company

Our client is a Shared Services Center located in Lisbon. Right now, they are recruiting a Regulatory Affairs Project Manager to be a part of the GBS team!

Your new role

Supporting one or more Global Regulatory Strategist (GRS) in the development and implementation of the global regulatory strategy;

Delivering smart tactical plans to properly execute agreed regulatory strategies in collaboration with the regulatory subteam;

Adhering to standardized processes and workflows to safeguard regulatory compliance and seamless collaboration across interfaces;

As member of the regulatory subteam, ensuring that tasks get prioritized with focus on criticality for business; Being responsible to liaise with the relevant functional experts and participate in cross-functional teams as agreed in regulatory subteam;

Serving as business partner for strategies for CoCg optimization and drives creation and updates of product intormation.

What you need to succeed

Scientific university degree (Master or PhD) or equivalent in Life Science (pharmacy, biology, chemistry or related discipline);

Profound years of experience in the pharmaceutical industry of health authority;

Regulatory experience in a global setting, main territorial focus:

European Union/ US and Latin America, experience in APAC beneficial;

In-depth knowledge of relevant ICH/EU/US guidelines and regulations covering all aspects of regulatory submission and procedure management;

Sound understanding of relevant scientific;

Excellent English communication skills, both written and verbal, German and Spanish beneficial;

Strong project management, negotiation and leadership skills;

Flexible, pragmatic, solution-oriented, independent and proactive working style;

Ability to link long ranging visions/ concepts to one’s daily work and to lead, coordinate and synchronize multiple projects, overcome obstacles and be flexible in changing daily workload priorities.

What the Company can offer you

Competitive compensation package;

Excellent Work Environment (They are recognized as one of the Best Workplaces in Portugal);

Flexible Work Schedule;

Comprehensive learning plan;

Career & Personal Development.

Next step

If you are interested in this opportunity, click on the following link to send us your updated CV, or send it directly to: