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JEFFERSON WELLS
REGULATORY AFFAIRS SPECIALIST
* Brussels
* Contract duration specified
* Full Time, Home Office
* Published: 1 day ago
Apply Now
Save this Job
Regulatory affairs SpecialistJefferson WellsBrusselsBE2022-04-08T14:01:32Z
Will you be our new ambassador?
Jefferson Wells Life Sciences specializes in supporting pharma & biotech
companies in their daily challenges. Hence our interest in experts like you to
pass our team.
Let's look together at your first challenge with us!
YOUR RESPONSIBILITIES
The contractors will be Brussels based. Remote work is possible, but at least 1
day/week in the office is required. During the training it is advised to be
present more often.
Assignment is for 6 months.
Support RA activities in the EU, UK, Switzerland and the non-EU Balkan countries
for products approved through the centralized and decentralized/MRP procedures –
in collaboration with the Regulatory Liaison.
Primary activities include, but are not limited to:
• Provides administrative regulatory support during filing and review of new
submissions, variations, in order to safeguard submissions according to EU
requirements.
• Plans and coordinates new submissions, variations, CHMP referrals, FUM. to
ensure timely submission.
• Drafts of module 1 components and organizing the gathering of the module 1
components.
• Collaborates closely with Regulatory Operations to establish submission
timelines and content of Module 1.
• Collaborates closely with Country RA Registration Managers in order to ensure
timely submission.
• For the centralized procedure, supervises and coordinates the translation
process to ensure timely submission to EMA.
• Provides other administrative support related to Marketing Authorization
Applications to the Executive Director, Distinguished Scientist, Senior
Principal Scientist, Associate Principal Scientist or Senior Scientist as
needed.
• Ensures updates to regulatory databases.
YOUR PROFILE
• Bachelor degree , preferably in a science related to medicine, and at least
four years of experience in the pharmaceutical industry with knowledge of the
drug development and/or approval process.
• Good organizational skills, proven ability to multi-task, excellent written
and verbal communication skills in English.
• Can work across boundaries, demonstrates the ability to act as intermediary
across boundaries.
• Demonstrates the ability to evaluate new ideas and proposed methods for
practicality and ease of implementation.
• Demonstrates ability to coordinate tasks with others for timely completion and
to avoid setbacks.
• Demonstrates the ability to check regulatory documents to determine accuracy
and find potential errors.
WE OFFER
What can Jefferson Wells do for you?
As an ambassador you have the opportunity to grow within international companies
where you can build a strong network. Through a personal follow-up, you
receive quality support in every step that you accommodate. Finally, you enjoy
the opportunity to develop yourself personally and professionally through
internal training and education.
Are you interested? Apply now with your cv! or email
yannick.kizito@jeffersonwells.be
Apply Now
LOCATION
Open map
Jefferson Wells
1000 Brussels, Belgium
JEFFERSON WELLS
1. HR Services, Recruitment & Selection
Company Profile
31 Jobs
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WE USE COOKIES
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Nederlands
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We transmit personal data to third-party providers who help us to improve our
web services. In this context, we also create and enrich usage profiles (e.g.,
on the basis of cookie IDs), which may also be transferred outside the EEA. For
this and to be able to use certain services for the purposes listed below, we
require your consent. By clicking "Accept all", you agree to these (revocable at
any time). This also includes your consent to the transmission of certain
personal data to third countries, including the USA In case of doubt, the third
countries concerned, particularly the US, do not have the level of data
protection that you enjoy under the GDPR. This can have disadvantages such as a
more difficult enforcement of data subject rights, a lack of control over
further processing and transmission of the data or access to the data by
government agencies, US authorities, for control and monitoring purposes,
without you being entitled to legal remedies against this. *, in accordance with
Art. 49 (1) (a) GDPR. You can change your settings or refuse data processing
under "Settings or reject". You can change your selection at any time under
"Privacy Statement" at the bottom of the page.
Storing and/or retrieving information on a device
Cookies, device identifiers or other information may be stored on or retrieved
from your device for the processing purposes shown to you.
Personalised ads and content, ad and content measurement, audience insights and
product development
Ads and content can be personalised based on a profile. More data can be added
to better personalise ads and content. The performance of ads and content can be
measured. Insights about audiences who have viewed the ads and content can be
extracted. Data can be used to build or improve user experience, systems and
software.
Display third-party content (social networks, videos)
Content from social networks and embedded content from third-party providers can
be displayed.
Settings or reject
Accept All
You can also exercise your right to object to data processing based on
legitimate interests under “Privacy Statement”.
Privacy Statement