Apprentie Affaire Réglementaire

POSITION

Job Title:

Global Regulatory Affairs, Regulatory CMC Apprentice

Division / Function:

Global Regulatory Affairs (GRA), CMC Regulatory Strategy

Manager’s Job Title:

Director/ Senior Manager or Manager, CMC Regulatory Strategy

Location:

Paris, France

WHAT - Summary & Purpose of the Position

The position offers a 12 months apprenticeship in Global Regulatory Affairs, CMC Regulatory strategy and reports to the 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 molecules) pertaining to EU/US and export countries (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.

WHAT - Main Responsibilities & Technical Competencies

• 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:
• 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
• Contribute to the CMC regulatory assessment of changes providing strategic regulatory advice and support the preparation of the corresponding variations/ amendments as required.
• 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
• 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.
• GRA Trainee Academy active team member

- Attend/Present at GRA 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 GRA Trainee Academy (specific program designed to provide a framework for the GRA 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.

Knowledge & Experience (essential):

• Written and communication skills
• Strong scientific skills and interest for CMC area
• Ability to speak-up and act as a team player
• Ability to demonstrate problem-solving skills and intellectual curiosity
• Strong knowledge of Microsoft Office, especially Excel tool

Knowledge & Experience (preferred):

• Previous experience in Pharmacy, Regulatory and/or Quality

Education / Certifications (essential):

• Degree (min Master 2 level) in scientific discipline (Pharmacy, Chemistry, Quality, Biological sciences or Engineering)

Language(s) (essential):

• Intermediate English if not mother tongue