Regulatory Submission Manager
Il y a 6 mois
Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service, functional service provider and consulting - allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
**What we offer**:
The Regulatory Business Operations Division is currently looking for a** Regulatory Submission Manager**:
Accountable for planning and execution of the dossier for product(s):
- Lead the dossier preparation and compilation, coordinate and manage the interaction with the different stakeholders.
- Responsible for the filing in due dates
**Accountable for leading regulatory submission activities covering whole product lifecycle (from FIH to license withdrawal)**
- Member of the Global regulatory Team, coordinating all activities relating to management of submission
- Support GRL while building submission plan and annual regulatory roadmap. Responsible for generating and follow-up of the timetables. Provide dashboard for steering the regulatory activity to the GRL and Global Regulatory Team
- Responsible for the coordination of pre-submission activities (CTA, IND dossiers)
- Responsible for the coordination of initial submissions (M1 to M5) in EU and US
- Responsible for compiling the reference dossier (M2 to M5) in close collaboration with the GRL and Regulatory CMC: producing e-CTD backbone structure of the reference dossier, and identifying owners and timing for each deliverable,
- Responsible for the planning of the dossier preparation WW on the basis of reference dossier, in close collaboration with RRL/local regulatory managers who provide the local requirements and adapt the TOC of the core dossier
**Manage the dossier preparation and follow the submission**
- Responsible for dossier building:
- Creating detailed Submission plan in MS Project for EU, US and Rest of the world
- Creating table of content based on reference dossier and local requirements provided by Regional Regulatory leads
- Setting up dossier according to the local TOC, consolidate specific local format/technical requirements
- Coordinate the collection of the documents related to the dossier preparation for submission (e.g. integrate CMC part to the dossier )
- Liaise with publishing service provider for dispatch to markets and informs regional leads and GRL
- Ensure the follow up of the dispatch and submission with the support of the external vendor and LRA if applicable
- Responsible for updating dossier and core reference according to identified needs (e.g. new data, new requirements, questions for Agencies)
- Oversight of the regulatory databases. Define and trigger QC and monitoring action in collaboration with System Business Expert. Follow CAPA.
**KPI responsibilities and interactions**
- Meeting pre-agreed submission milestones for products, the submission manager coordinates or flagging as early as possible when he becomes aware of slipping timelines
- Is member of the Global Regulatory Team
- Key interfaces outside WRA: Medical Writing, TA and R&D Operations, TxM, Clinical development, Industry
**Minimum Requirements**:
- Regulatory Affair Officer with more than 5 years’ experience in regulatory affairs and project management.
- Experience of leading the coordination of preparation of high-quality submissions to regulatory agencies for marketing approval within project timelines.
- Experience in the Pharmaceutical industry in Regulatory Affairs or Drug Development (experience in Oncology if possible).
- Project management experience and ability to work independently.
- Excellent communication skills, organization and planning skills and attention to detail.
- Must be able to communicate effectively in English.
- Experience with MS Project **mandatory**
The position is based in Paris Area with possibility of few days in remote
**Summary**:
- Type of job:
Full-time
- Location:
France
- Capability:
Regulatory Affairs
**Contact**:
- **Clara Rousselet-Blanc**
Talent Manager
-
Cmc Regulatory Manager
Il y a 6 mois
Paris, France Excelya Temps pleinCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model - leveraging full-service,...
-
Manager, Regulatory Cmc
Il y a 5 mois
Paris, France Cellectis Temps plein**Job Description**: The Manager or Senior Manager, Regulatory CMC: - Ensures regulatory compliance between the practices of the Cellectis sites, the regulatory files and the regulations in force such as US and EU Regulations, ICH and Pharmacopoeia. - defines and organize the Cellectis Regulatory CMC activities. - Is responsible for the execution of the...
-
Regulatory Affairs Strategist
il y a 4 semaines
Paris, Île-de-France Apsida Life Science Temps pleinApsida Life Science is seeking a highly experienced Regulatory Affairs Consultant with a strong background in regulatory strategy and new submissions in LATAM, APAC, or International markets.The successful candidate will support the global regulatory strategies for product registrations, ensuring compliance with local regulations while optimizing timelines...
-
Regulatory Operations Director
il y a 3 semaines
Paris, Île-de-France Veeva Systems Temps pleinThe RoleThis Director role requires a deep understanding of the global life sciences regulatory operations space and supporting technology solutions.The individual will be responsible for growing Veeva's Regulatory Information Management market share and will work with a team of Life Sciences industry and technology experts.Key Responsibilities:Grow and...
-
Regulatory Affairs Director
il y a 4 semaines
Paris, Île-de-France Advanced Resource Managers Temps pleinAdvanced Resource Managers seek an experienced Regulatory Affairs Director to lead CMC strategy for a leading Biotech business through a CRO.The ideal candidate will provide innovative solutions, leveraging global regulatory therapeutic area expertise and strategic regulatory intelligence to support product development from preclinical through registration...
-
Regulatory Affairs Director
il y a 4 semaines
Paris, Île-de-France Meet Temps pleinMeet Meet, a company dedicated to innovation and excellence. We are seeking a highly skilled Regulatory Affairs Director to spearhead our regulatory programs.Key ResponsibilitiesStrategic Leadership: Develop and execute regulatory strategies to ensure compliance across all products and markets, anticipating and addressing regulatory challenges.Program...
-
Regulatory Operations Director
il y a 1 mois
Paris, Île-de-France Veeva Systems Temps pleinThe RoleThis Director role requires a deep understanding of the global life sciences Regulatory Operations space, RegOps business processes, and supporting technology solutions. As a key member of the Veeva team, you will be responsible for growing the company's Regulatory Information Management market share.Key ResponsibilitiesDevelop and execute strategies...
-
Director Strategy
Il y a 3 mois
Paris, France Veeva Systems Temps pleinThe Role This Director role requires a deep understanding of the global life sciences Regulatory Operations space, RegOps business processes and supporting technology solutions. This role will be responsible for growing Veeva’s Regulatory Information Management market share. In this role, the individual will have the opportunity to work with a team of...
-
Regulatory Information Management Officer
Il y a 6 mois
Paris, France SERB Pharmaceuticals Temps pleinSerb Pharmaceuticals is a growing international specialty pharmaceutical group that is a dedicated ally to healthcare providers treating patients with critical conditions, focusing on emergency care and rare diseases. We have over 400 employees in 10 countries. Our portfolio of 80+ rescue medicines makes a real difference in the lives of patients and their...
-
Senior Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France PROJECTUS Temps pleinSenior Regulatory Affairs Specialist - Medical Devices (MDR)We are seeking a seasoned Regulatory Affairs professional to join our team at Projectus Consulting, a renowned brand within the Surgical Device market. As a result of our continued success and remaining at the forefront of pioneering medical device innovation, we require an experienced expert to...
-
Regulatory & Start Up Specialist, French Speaker
Il y a 6 mois
Paris, France Novasyte Temps pleinIQVIA MedTech Clinical Solutions, specializes in clinical research for Medical Devices and In-Vitro Diagnostic (IVD) products.- IQVIA MedTech’s focused expertise meets the growing needs of device Sponsors to justify product safety and effectiveness as well as reimbursement and adoption challenges due to increased scrutiny by regulators, end-users, and...
-
Regulatory Affairs Senior Manager
il y a 2 semaines
Paris, France Cellectis Temps pleinPrise de poste non définie BAC +5 Paris Nombre de postes non défini CDI Rémunération non définie **Description du poste et des missions**: **WHO WE ARE** Cellectis is a **global clinical-stage biopharmaceutical** company. **Pioneers and innovators** in our field, our mission is to develop **innovative treatments** for **patients with unmet medical...
-
Regulatory Affairs Manager
Il y a 6 mois
Paris, France Perrigo Temps plein**Description générale**: **_ HRA Pharma Rare Diseases_** is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world. We have over 15 years’ experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing’s syndrome and...
-
Regulatory Affairs Manager
Il y a 6 mois
Paris, France Perrigo Temps plein**Description générale**: **_ HRA Pharma Rare Diseases_** is dedicated to bringing the best care and services to people living with rare diseases and is committed to supporting healthcare professionals all over the world. We have over 15 years’ experience in rare and ultra-rare diseases with a portfolio of medicines that address Cushing’s syndrome and...
-
Drug Regulatory Affairs Officer
il y a 3 semaines
Paris, Ile-de-France Scienta Temps pleinLocation: Paris, FranceCompany Overview:This is an exciting opportunity to contribute to the expansion and success of a leading health and wellness company.Job Description:In this role, you will be responsible for ensuring regulatory compliance and managing regulatory submissions for the company’s products. Your key responsibilities will include:Verifying...
-
Drug Regulatory Affairs Officer
il y a 3 semaines
Paris, France Scienta Temps pleinLocation: Paris, FranceCompany Overview:This is an exciting opportunity to contribute to the expansion and success of a leading health and wellness company.Job Description:In this role, you will be responsible for ensuring regulatory compliance and managing regulatory submissions for the company’s products. Your key responsibilities will include:Verifying...
-
Regulatory Expert for Biologics Development
il y a 2 semaines
Paris, Île-de-France VCLS Temps pleinJob SummaryWe are seeking an experienced Regulatory Scientist to join our team as Associate Director, Regulatory Science CMC. As a key member of our team, you will provide strategic guidance on CMC development pathways, regulatory submissions, and risk assessment.About the RoleThis is a pivotal opportunity for a highly skilled professional to contribute to...
-
Regulatory Affairs Project Manager
Il y a 6 mois
Paris, France TFS HealthScience Temps pleinTFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. **Join Our Team as a** **Regulatory Affairs Project...
-
Regulatory Affairs Specialist
Il y a 6 mois
Paris, France Nanobiotix Temps pleinNanobiotix is happy to welcome a CMC manager, regulatory affairs to provide valuable support to our mission to advance groundbreaking nanomedicine solutions. At the forefront of pioneering nanomedicine approaches that could redefine cancer treatment, our team at Nanobiotix is dedicated to creating innovative solutions to impact countless lives across the...
-
Regulatory Affairs Specialist
il y a 4 semaines
Paris, Île-de-France ProductLife Group Temps pleinRegulatory Affairs Specialist We are seeking a Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our regulatory team, you will be responsible for ensuring the delivery of regulatory activities performed onsite in the Paris region. About us: Group 10 Responsibilities: Coordination of the collection of...