Alternance - Global Regulatory Affairs Operations

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...

**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...

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...

**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...

**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...

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.**: -...

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 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...

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...

**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...

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:...

**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...

**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...

**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...

**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...

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 OverviewWe are seeking a highly motivated and experienced Director, Regulatory Systems Operations to join our team at Ipsen Pharma. This role will be responsible for enhancing our Regulatory Information Management (RIM) capabilities, ensuring compliance of regulatory data, and driving agility in our regulatory processes using Veeva systems.

**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...