Title:
Alternance Global Regulatory Affairs CMC Strategy M/F

Company:
Ipsen Innovation (SAS)

Job Description:

#IpsenTraineeSquad

Ipsen is pleased to open a 12-month apprenticeship (alternance) in the Global Regulatory Affairs, CMC Regulatory strategy team! We are looking for a motivated Regulatory Affairs CMC student to work in our R&D office in Les Ulis, France.
• 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 date in September 2023

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
Gometz-le-Châtel France

Salary Criteria