Alternance - Regulatory Affairs Cmc F/m - From

**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...

Job Title: Expert CMC Regulatory Division / Function: Global Regulatory Affairs - CMC Regulatory Manager (Name, Job Title): Senior Manager, Director, or Senior Director CMC Regulatory Location: Ipsen location in France / Ireland / UK **Summary / purpose of the position** - Prepare the CMC regulatory strategy for assigned projects under the strategic...

**Summary / purpose of the position** **Provide strategic and technical CMC regulatory input to improve processes and facilitate interfaces with stakeholders for the purpose of maximizing CMC regulatory business from early development to life cycle management, facilitating submissions, approvals from CMC perspective of new assets and variations in a timely...

**Summary / purpose of the position** - Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy with all stakeholders. - Takes accountability/decision making for all Global CMC-Regulatory files in the biologic cluster. - Accountable for early communication and validation from worldwide health authorities for any...

Job Title**: Sr Director CMC Regulatory Strategy - Small molecules** Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Head of CMC Regulatory Strategy Location: Balard/ Paddington **Summary / purpose of the position** - Leads the team to deliver high quality CMC-Regulatory files, ensuring alignment of regulatory strategy...

Job Title**:Senior Manager, CMC Technical writing Division / Function: Global Regulatory Affairs (GRA) Manager (Name, Job Title): Director/ Sr Director, CMC Regulatory Location: Balard/ Dublin/ Paddington **Summary / purpose of the position** The Senior manager, CMC-technical writing will have responsibility for the CMC (Chemistry Manufacturing and...

Job title**:Senior Manager, Global Regulatory Affairs TA** Department: Research & Development, Global Regulatory Affairs (GRA) Line Manager (name, job title): VP/Sr Dir/Dir, Global Regulatory Affairs, Therapeutic Area Location of the role: France, (Les Ulis or Boulogne-Billancourt) **Summary / purpose of the position** - To be accountable for the...

As a Regulatory Operation internship, you will play a role in supporting Regulatory operation projects aimed at enhancing regulatory activities by using Regulatory information management system capabilities. You will work closely with our Regulatory, Regulatory operation, System& IT team to contribute to the development and implementation of strategies to...

Estimate Salary: $120,000 - $180,000 per annumCompany OverviewIpsen Pharma is a leading pharmaceutical company dedicated to improving patient outcomes through innovative therapies. Our team is passionate about delivering high-quality solutions that meet the evolving needs of our customers.About the RoleWe are seeking an experienced Regulatory Systems Lead to...

About GeopostGeopost, a European leader in parcel delivery and solutions for e-commerce, operates in more than 50 countries across all continents through its network of expert delivery brands, including: DPD, Chronopost, SEUR, BRT, Speedy and Jadlog. Leveraging its industry-specific expertise, Geopost is further growing the development of Out-Of-Home...

**Position** Job Title**:Director, Regulatory Systems Lead** Division / Function: Global Regulatory Affairs - Regulatory Operations Manager (Name, Job Title): Head of RegOps, GRA Location: Boulogne / Les Ulis - France **Summary / purpose of the position** Position Overview: **Main responsibilities / job expectations** **Direct management of the system...

**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...

**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...

**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...

Job title: Regulatory Manager, Therapeutic Area Department: Global Regulatory Affairs (GRA) Line Manager (name, job title): Director/Sr Dir/VP Therapeutic Area Head, Global Regulatory Affairs **Purpose of the position** - ** Develop and implement regulatory strategies for the assigned projects and all its components for a major region or worldwide.**: -...

Title: Director, Regulatory Systems Company: Ipsen Innovation (SAS) Job Description: Position Job Title: Director, Regulatory Systems Lead Division / Function: Global Regulatory Affairs - Regulatory Operations Manager (Name, Job Title): Head of RegOps, GRA Location: Boulogne / Les Ulis - France Summary / purpose of the position Position...

**Purpose of the position** - ** Be responsible for Regulatory Submission and Life Cycle Management for assigned products and to identify and then communicate the implication of upcoming regulations that may impact the process. This also includes Geoexpansion and ESG projects.**: - ** Develop and implement regulatory strategies for the assigned projects and...

Title: Director, Regulatory Systems Company: Ipsen Innovation (SAS) Job Description: Position Job Title: Director, Regulatory Systems Lead Division / Function: Global Regulatory Affairs - Regulatory Operations Manager (Name, Job Title): Head of RegOps, GRA Location: Boulogne / Les Ulis - France Summary / purpose of the position Position Overview:...

QUELLES MISSIONS VOUS SERONT CONFIEES ? Rattaché(e) à la Direction des Affaires Réglementaires Groupe, au sein de l’Unité Stratégie CMC, vous aurez comme mission principale de définir et de proposer les stratégies réglementaires CMC associées aux développements, enregistrements et variations des produits/projets confiés pour les zones Europe...

**As Regulatory Compliance Manager within the GRA Excellence organization and under the Regulatory Compliance Senior Manager**: - Oversee all compliance aspects related to Global Regulatory Affairs activities in accordance with regulatory requirements and IPSEN standards. - Share compliance outcomes with the Global Regulatory Affairs community and relevant...