Apprenti GRA Oncologie

About this role

Responsibilities

• /
• job
• expectations
• 12
• months
• apprenticeship
• –
• weekly
• schedule
• can
• be
• flexible
• and
• discussed
• during
• interview
• Resume
• and
• cover
• letter
• (Lettre
• de
• motivation)
• are
• expected
• to
• apply
• for
• the
• position
• Regulatory
• coordination
• Contributes to the drafting and implementation of the regulatory strategy (e.g. Regulatory Strategy Documents)
• for
• specific
• projects,
• ensures
• that
• the
• needs
• for
• his/her
• region
• are
• adequately
• reflected.
• Supports
• the
• coordination
• of
• the
• preparation
• with
• relevant
• functions
• and
• the
• assembly
• of
• regulatory documentation to be submitted according to the strategy validated.
• Contributes
• to
• critical
• and
• constructive
• review
• of
• regulatory
• dossiers
• (MAA/NDA,
• New
• indication,
• CTA, special designation, pediatric development, etc.)
• Ensures
• quality
• authoring
• of
• core-administrative
• parts
• of
• submission
• packages.
• Works
• on
• the
• content
• of
• regulatory
• submission
• dossiers
• in
• collaboration
• with
• GRA
• Director
• and approves change control.
• Ensures
• adequate
• planning
• and
• timelines
• management/adjustment
• depending
• on
• the
• deliverable.
• Attends/Drives
• cross
• functional
• meetings
• with
• Project
• team
• depending
• on
• deliverables
• Supports
• Europe
• marketing
• authorization
• procedures
• (centralized,
• decentralized,
• and/or
• MRPs)
• with support from GRA Director and Local Regulatory Affairs (LRAs) when applicable.
• Supports
• NDA/sNDA/Health
• Canada
• submissions
• when
• applicable.
• Participates
• to
• the
• preparation
• of
• regulatory
• agencies
• consultations
• (e.g.
• EMA
• or
• national
• scientific Advice, protocol assistance, FDA meetings, Health Canada meetings).
• Participates
• to
• the
• coordination
• of
• the
• responses
• of
• questions
• from
• authorities.
• Ensures
• adequate
• coordination
• of
• regulatory
• activities
• through
• reliable
• liaison
• with
• LRAs.
• Maintains
• a
• continuous
• flow
• of
• information
• with
• LRAs
• depending
• on
• the
• progress
• of
• projects.
• Ensures
• that
• the
• manufacturer
• is
• informed
• of
• the
• registered
• dossier
• to
• allow
• manufacturing
• in compliance with the terms of the marketing authorization.
• Strong
• collaboration
• with
• CMC
• Regulatory
• and
• Intercontinental
• Regulatory
• teams
• Interaction
• with
• Regulatory
• Oncology/Neurology
• therapeutic
• areas
• and
• knowledge
• sharing
• Participates
• to
• maintaining
• good
• relationships
• with
• working
• partner
• when
• applicable
• (CROs,
• vendors, development partners …)
• Compliance
• Operates
• according
• to
• Regulatory
• and
• Ipsen
• SOPs
• Ensures
• that
• registration
• status
• is
• adequately
• reported
• in
• VREG
• (regulatory
• tracking
• tool)
• through
• data
• entry.
• Regulatory
• Intelligence
• Contributes
• to
• Regulatory
• intelligence,
• by
• tracking
• and
• analysing
• the
• evolution
• of
• regulations
• relating
• to his/her areas;
• Informs
• the
• relevant
• departments
• and
• answers
• their
• questions.
• 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.
• Knowledge,
• abilities
• &

Requirements

• Education
• /
• Certifications:
• Degree
• (min
• Master
• 2
• level)
• in
• scientific
• discipline
• (Pharmacy,
• Chemistry,
• Biological
• sciences)
• Knowledge
• of
• regulatory
• procedures
• in
• at
• least
• one
• region
• is
• Excellent
• written
• and
• communication
• Ability
• to
• influence
• others
• and
• act
• as
• a
• team
• player
• Ability
• to
• demonstrate
• problem-solving
• and
• intellectual
• curiosity
• Strong
• scientific
• and
• interest
• for
• Oncology
• Disease
• area.
• Nous nous engageons à créer un lieu de travail où chacun se sent écouté, valorisé et soutenu, où nous incarnons « The Real Us*». La valeur que nous accordons aux différentes perspectives et expériences motive notre engagement en faveur de l'inclusion et de l'égalité des chances. Lorsque nous intégrons des modes de pensée diversifiés, nous prenons des décisions plus réfléchies et découvrons des solutions plus innovantes. Ensemble, nous nous efforçons de mieux comprendre les communautés que nous servons. Cela signifie que nous voulons également vous aider à donner le meilleur de vous-même lorsque vous postulez à un poste chez nous. Si vous avez besoin d'aménagements ou d'aide pendant le processus de candidature, veuillez en informer l'équipe de recrutement. Ces informations seront traitées avec soin et n'auront aucune incidence sur le résultat de votre candidature. *Soyons nous-même

About Ipsen

Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram . Job Description: Job Title: Global Regulatory Affairs, Oncology Apprentice Division / Function: Global Regulatory Affairs (GRA), Oncology Manager (Name, Job Title): GRA Senior Director or GRA Director, Oncology