alternance global regulatory cmc
Detail de l'annonce :
The position offers a 12 months apprenticeship in Global Regulatory
Affairs, CMC Regulatory strategy and reports to the Senior Director,
Senior Manager or Manager in GRA CMC Regulatory Strategy.
* To support global regulatory Chemistry and Manufacturing Control
(CMC) strategy development and CMC dossiers preparation on a portfolio
of R&D products (small and large molecules) pertaining to EU/US and
Intercontinental regions (incl. Brazil, Russia, China, Japan….)
* Take part of strategic and operational tasks/discussions for early
and/or late stage programs.
* Take part in developing and promoting harmonized tools across all
projects throughout the CMC group and the global regulatory affairs
community.
ROLES AND RESPONSIBILITIES
Regulatory coordination
*
Participate to the CMC regulatory strategy liaising with cross
functional teams
*
Check current regulations to ensure strategy is developed in alignment
*
Participate to build, review and maintain CMC regulatory documentation
for ongoing clinical programs (IMPD/IND)
*
Participate in the authoring and reviewing phase of briefing documents
for consultation with Regulatory Agencies
*
Support the definition of the roadmaps build to guide the preparation
of global dossier taking into account geographical specificities
identified for submission to ensure dossier is in line with local
regulatory requirements
*
Support preparation of the strategy for response to question and
participate in response authoring, review, submission and follow up
*
Attend relevant project and non -project related team meetings
*
Potentially present the CMC regulatory output at CMC pharmaceutical
development forums
COMPLIANCE
*
Operates according to Regulatory and Ipsen SOPs
*
Review and update trackers
Regulatory Intelligence
*
Contributes to Regulatory intelligence, by tracking and analysing the
evolution of regulations relating to CMC topics;
*
Informs the relevant departments and answers their questions as
needed.
GRQ and GRQ Trainee Academy active team member
*
Attend/Present at GRQ knowledge sharing meetings
*
Attend Ipsen internal events (Presentations, external speakers,
forums, webinars, celebrations …)
*
Ensures adequate reporting of his/her activities and participates to
various meetings depending on project assignments
*
Be an active member of the GRQ Trainee Academy (specific program
designed to provide a framework for the GRQ interns and apprentices
only): attending proposed trainings, prepare webcast, share
experience, build network, site visits (if possible), get exposure to
senior management. Provide feedback and participate in Trainee Academy
further development and visibility.
EHS MISSIONS
*
Respect the regulations and EHS procedures in force.
*
Participate in the EHS performance of the site by reporting risks,
malfunctions or improvements.
*
Participate in mandatory EHS training.
PROFILE
* Degree (min Master 2 level) in scientific discipline (Pharmacy,
Chemistry, Quality, Biological sciences or Engineering)
* Preferred previous experience in Pharmacy, Regulatory and/or
Quality
* Intermediate English if not mother tongue
* Excellent written and communication skills
QUALIFICATION
* Degree (min Master 2 level) in scientific discipline (Pharmacy,
Chemistry, Quality, Biological sciences or Engineering)
* Preferred previous experience in Pharmacy, Regulatory and/or
Quality
* Skills
* Intermediate English if not mother tongue
* Written and communication skills
* Ability to speak-up and act as a team player
* Ability to demonstrate problem-solving skills and intellectual
curiosity
* Strong scientific skills and interest for CMC area.
* Strong knowledge of Microsoft Office, especially Excel tool
Location : Les Ulis
12 months contract
Starting in September 202
Dans le cadre de ses recrutements IPSEN s’engage au respect de
l’égalité de traitement des candidats, indépendamment du sexe, de
l’âge, de l'orientation sexuelle, de l'origine ethnique, de la
couleur de la peau, de la nationalité, du handicap ou de
l'appartenance à un syndicat.