Alternance - Regulatory Affairs Cmc F/m - From

il y a 2 jours

Les Ulis, France Ipsen Innovation (SAS) Temps plein

**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.

**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

Languages:

- Intermediate 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.
- Strong knowledge of Microsoft Office, especially Excel tool
- #IpsenTraineeSquad_

  • Apprenti Cmc Regulatory

    il y a 2 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    12 months apprenticeship - weekly schedule can be flexible and discussed during interview - 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...

  • Senior Manager Regulatory Affairs

    il y a 4 jours

    Les Ulis, France elemed Temps plein

    Senior Regulatory Affairs Consultant The Company: If you are a QA/RA professional with an interest in innovation and groundbreaking development, we have an incredible role for you. This is a chance to join an established midsize Software as a Medical Device company. Role Responsibilities & Qualifications: Develop and execute regulatory strategies/plans that...

  • Senior Regulatory Affairs Specialist

    il y a 6 jours

    Issy-les-Moulineaux, France Johnson & Johnson MedTech Temps plein

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...

  • Director Regulatory Affairs Rare Diseases

    il y a 7 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **SUMMARY OF THE ROLE** - To be accountable for the strategy, tactics and implementation of all regulatory aspects of the assigned programs and all of its components for assigned region or worldwide. - To provide regulatory expertise to R&D, Franchise and Commercial Operations for assigned products/projects. - Act as the interface between the...

  • Project Manager Regulatory Ecosystems

    il y a 1 semaine

    Les Ulis, France IPSEN Temps plein

    **Title**: Project Manager Regulatory Ecosystems **Company**: Ipsen Innovation (SAS) In close collaboration with the Regulatory Systems Owner and Regulatory System Support and within the framework to leverage and improve the Regulatory Ecosystems - Manage systems trainings - Participation in tool’s evolution - Oversight manager provider - Manager systems...

  • Manager, Global Regulatory Affairs

    il y a 7 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Develop and implement regulatory strategies for the assigned projects and all its components for a major region or worldwide.**: - **Be responsible for the strategy, and implementation of all regulatory aspects of the assigned projects and all of its components for a major region or worldwide.**: - **Provide regulatory expertise to R&D, Franchise and...

  • Senior Director, Policy

    il y a 2 jours

    Les Ulis, France Nokia Temps plein

    Senior Director, Policy & Government Affairs – Nokia Job Description The Senior Director, Policy & Government Affairs will lead Nokia’s U.S. congressional affairs, lobbying strategy, and engagement with federal policymakers and staff. This role will serve as the primary interface between Nokia and the U.S. Congress and relevant committees. The individual...

  • Global Regulatory Strategist

    il y a 6 jours

    Issy-les-Moulineaux, France Johnson & Johnson MedTech Temps plein

    A global medical technology company is seeking a Senior Regulatory Affairs Specialist in Issy-les-Moulineaux, France. The role involves supporting regulatory compliance for Ethicon Endomechanical products, collaborating with cross-functional teams on new EU regulations, and contributing to the creation of Technical Documentation for MDR CE marking. Ideal...

  • Government Affairs Manager

    il y a 2 jours

    Issy-les-Moulineaux, France Johnson & Johnson Temps plein

    governmental affairs manager Location: Franc e, Issy Les Moulineaux Contract: full-time, permanent The governmental affairs manager within the External Affairs team is tasked with building an institutional and political environment favorable to therapeutic innovation for equitable and sustainable access for patients. He/she builds a strategy aligned with...

  • Global Labeling Manager

    il y a 7 jours

    Les Ulis, France Ipsen Innovation (SAS) Temps plein

    **Summary / purpose of the position** **To develop and maintain Core labelling documents and support USPI/other local product information throughout the product life cycle in accordance with Ipsen Processes for assigned product(s)** **To provide labelling guidance to support product teams and senior management in defining labelling strategy** **To provide...