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Regulatory affairs Manager

  • City / Town: BEL
  • Date posted: Nov 8 2017 4:30PM
  • Sector: Regulatory
  • Employee status: Regular
  • Employment status: Full Time
  • Job reference: 1720692
  • Consultant: Ingrid Mertens
The Regulatory Affairs Manager (RAM) is a crucial and strategic position within the company.
The RAM will provide critical counsel, leadership and will be in charge of strategic communication on issues that impact the members.
This person will be responsible for providing the expected services and support to our members regarding all kinds of regulatory needs as for example law interpretation, new laws, issues with product registration, advertising complaints, prices dossiers, medical claims, brand name etc..
He/She will advice on new policies and legislation decision making process, coming from both national and European authorities, and explain their business consequences on   and her members.
This person is also responsible for participating to all kinds of RA meetings with the authorities and other stakeholders to represent the interest and the position of our members as well as to collect and communicate information to our members. He/She will advise on new policies and legislation decision making process and explain their business consequences and her members.
This person will also participate to theRA group meetings in order to explain to the members the new trends and laws but he/she will also try to shape the best position and follow up the decision taken.
This person will communicate constantly with our members through the internet site, e-mails but also personal contacts.
This position reports directly to the general manager.


Areas of competence:

Accountability: clear commitment to achieve the agreed result.

Influence: influence directly and indirectly the external environment to explain to our members needs and expectations. Debates alternative views to challenge the status quo and come to more valuable alternatives.

Environment knowledge: understands how decisions and changes in the pharmaceutical/legislative environment are taken.

Proactive: anticipates specific future events to create opportunities and avoid problems.

Profile and experience:

Strong scientific university degree.

Experience in regulatory affairs including OTC products (medicines, -food supplements, medical devices, cosmetcis)- (min 3 years).

o Price dossiers, umbrella branding, product claims, product registration, participation in authorities’ working groups, patient information, advertising, etc.

Existing network within the industry as well as the authorities

Dynamic, autonomous, team player, communication capacity, well organized.

Strong commitment.

Fluent in Dutch, French and English (verbal and written).

About Quintiles?

QuintilesIMS is a leading global healthcare provider of integrated information and technology-enabled services. As one of FORTUNE’s 2017 “World’s Most Admired Companies,” we help you choose the path that defines your success. With global opportunities, innovative tools and outstanding leadership, you’ll have the support you need to make a positive difference in patient health. Join us on the journey!