Stagiaire Cmc Regulatory Strategy

Job Title: Global Regulatory Affairs, **Regulatory CMC Internship - BIOTECH PRODUCTS**

Division / Function: Global Regulatory Affairs (GRA), CMC Regulatory Strategy, Biological products

Manager (Name, Job Title): Senior Director/ Senior Manager or Manager, CMC Regulatory Strategy

Location: 70 rue Balard 75015 PARIS

**Summary / purpose of the position**

The position offers a 6-month internship for a Master 2 (or equivalent) in Global Regulatory Affairs, CMC Regulatory strategy, Biological products 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 (large molecules) pertaining to EU/US regions
- Take part of strategic and operational tasks/discussions for development stage programs.
- Take part in developing and promoting harmonized tools across all projects throughout the CMC group and the global regulatory affairs community.

**Main responsibilities / job expectations**
- 6-month internship (full time)
- **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 and follow-up of the roadmaps built 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.

**Knowledge, abilities & experience**

Education / Certifications:

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

**Experience**:

- Preferred previous experience in Pharmacy, Regulatory and/or Quality, or in biotechnology (analytics, manufacturing process)

Languages:

- Professional English if not mother tongue

**Key Competencies Required**
- 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 and biotech complex products
- Strong knowledge of Microsoft Office, especially Excel tool

**We are**:

- Inclusive and diverse
- Engaged with communities
- Ethical and compliant
- Dedicated to caring responsibly for our people and the environment
- ** Committed to a proactive approach to patient centricity**

**We are**:

- Insights-driven
- Responsible for leveraging our collective intelligence
- Dedicated to testing, experimenting and piloting
- Externally focused
- ** Committed to becoming data
- and science-driven**

**We are**:

- Agile and decisive
- Innovative
- Entrepreneurial
- Determined to be a partner of choice for all our stakeholders
- ** Committed to proactive collaboration**

**We are**:

- Open to feedback
- Ready to speak up
- Listeners
- Respectful
- ** Committed to taking responsibility for our words and actions**

**We are**:

- Focused and performance-driven
- Consistent in promoting single-point accountability
- Passionate about celebrating success
- Prepared to unleash our full potential
- ** Committed to excellence in