Senior/ Regulatory Affairs Manager

Il y a 7 mois

Paris, France Novasyte Temps plein

Job Overview

Individual contributor with advanced knowledge acquired from several years of experience in the professional discipline. Works independently under limited supervision.

Essential Functions
- Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or may act as a Project Manager for a stand-alone project, with guidance from senior staff as appropriate;
- Competently writes regulatory and/or technical documents with mínimal review by senior staff;
- Establishes relationships with many customers; may meet face to face without rest of team to discuss regulatory issues and present lessons learned. Adopts a proactive and flexible approach to resolve any issues;
- Undertakes detailed review and management of budgets related to projects, including out of scope activities. Ensures revenue is recognised and challenges when appropriate, may seek guidance from senior staff as appropriate;
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
- May present to clients at bid defense meetings by phone or in person, for a range of regulatory deliverables, at discretion of senior staff;
- May write new regulatory standard operating procedures, and/or propose revisions and/or act as reviewer for regulatory standard operating procedures, as assigned and appropriate.
- May be involved in a Regulatory and/or IQVIA Initiative;
- Performs other tasks or assignments, as delegated by Regulatory management;
- May manage meetings with Regulatory Agencies;
- May be assigned as Reviewer and/or Approver for Regulatory standard operating procedures or cross-functional standard operating procedures owned by other operations;
- May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative;
- Performs other duties, as business needs require;

**Qualifications**:

- French pharmacist diploma.
- Bachelor's Degree Degree in Lifescience or related discipline Req
- Master's Degree Degree in Lifescience or related discipline
- At least 8 years relevant experience
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
- Possesses a specific regulatory or technical expertise. Sufficient knowledge of managing regulatory projects, project deliverables on a time bound manner;
- Expert in planning and delivering work on time keeping quality parameter in mind;
- Knowledge of regulatory procedures in appropriate region - particularly marketing authorization transfers and relevant cross-functional dependencies;
- Good working knowledge of regional regulatory intelligence;
- Ability to work closely with client regional heads to determine the MAT, Regulatory Publishing & submission strategy and execute marketing authorization transfer plan, if applicable;
- Good understanding of pharmacovigilance activities relevant to transfer of marketing authorization;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating procedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Experience of involvement in regulatory strategy and determination of documentation requirements, timelines, budgets for MATs, Publishing projects;
- Project leadership experience;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Ability to adapt quickly to a rapidly changing environment;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies

LI-Remote

LI-KIMBERLYODONOGHUE

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Regulatory Affairs Senior Manager

    il y a 3 semaines

    Paris, France HSBC Temps plein

    The Compliance function is a Second line of defence (2nd LoD) function, responsible for reviewing and challenging the activities of the Group’s businesses (also referred to as “the 1st LOD”) to ensure that they effectively manage as “Risk Owners” the risks inherent in or arising from the conduct of their activities and for which they are...

  • Regulatory Affairs Manager

    Il y a 7 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 7 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...

  • Senior Manager/ Associate Director, Regulatory

    Il y a 7 mois

    Paris, France Stirling Q&R Ltd Temps plein

    On-site presence in the South of France once per month for 2-3 days. Stirling Q&R, a leading recruitment company, is currently assisting our esteemed client in the search for a highly experienced Senior Manager/Associate Director, Regulatory Affairs. Our client, a renowned global biotech company specializing in oncology, is dedicated to improving treatment...

  • Principle Regulatory Affairs Project Manager for Nutrition Products

    il y a 2 semaines

    Paris, France Groupe ProductLife Temps plein

    Principle Regulatory Affairs Project Manager for Nutrition Products - 377Location: Europe, FranceContract Type: PermanentJob DescriptionTo strengthen our scientific and regulatory affairs team, our Business Unit Medtech and Consumer Health is seeking a Senior Regulatory Affairs Principle Consultant with in-depth experience working on Nutrition and Consumer...

  • Regulatory Affairs Project Manager

    Il y a 7 mois

    Paris, France TFS HealthScience Temps plein

    TFS 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...

  • Senior Regulatory Affairs Specialist

    Il y a 3 mois

    Paris, France Philips Temps plein

    **Job Title**: Senior Regulatory Affairs Specialist Job Posting Description **In this role, you have the opportunity to** Ensure that products comply with all the relevant safety and environmental policies and regulations by implementing requirements, conditions, and enablers for SaMD products supporting the Cardiologs business within Ambulatory...

  • Regulatory Affairs Specialist

    Il y a 7 mois

    Paris, France Stryker Corporation Temps plein

    We are looking at a Regulatory Affairs Specialist to join and complete our team. You will be responsible for the coordination and preparation of document packages to secure timely approvals and maintain market clearance with a primary focus on EU + Turkey and/or other regions as assigned. **Key Areas of Responsibility** (non-exhaustive list**)**: - Leads...

  • Regulatory Affairs Specialist

    Il y a 7 mois

    Paris, France Nanobiotix Temps plein

    Nanobiotix 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 & Government Affairs Manager France &

    Il y a 5 mois

    Paris, France Red Bull Temps plein

    **Company Description**: The role will be responsible for advising on product - and labelling-related regulatory compliance, reviewing and advising on marketing collateral, and monitoring of and engagement on key regulatory and governmental changes that impact Red Bull’s strategic interests. This involves instructing and managing external legal counsels...

  • Regulatory & Government Affairs Manager France &

    Il y a 5 mois

    Paris, France Red Bull Temps plein

    **Company Description**: The role will be responsible for advising on product - and labelling-related regulatory compliance, reviewing and advising on marketing collateral, and monitoring of and engagement on key regulatory and governmental changes that impact Red Bull’s strategic interests. This involves instructing and managing external legal counsels...

  • Regulatory & Government Affairs Manager France &

    Il y a 5 mois

    Paris, France Red Bull Temps plein

    **Company Description** The role will be responsible for advising on product - and labelling-related regulatory compliance, reviewing and advising on marketing collateral, and monitoring of and engagement on key regulatory and governmental changes that impact Red Bull’s strategic interests. This involves instructing and managing external legal counsels and...

  • Regulatory Affairs Expert

    Il y a 2 mois

    Paris, France Qonto Temps plein

    **Our mission**? Making day-to-day banking easier for SMEs and freelancers thanks to an online business account that's combined with invoicing, bookkeeping and spend management tools. Thanks to its innovative product, highly reactive 24/7 customer support and clear pricing, Qonto has become the leader in its market. **Our journey**: Founded by Alexandre and...

  • Specialist, Regulatory Affairs

    il y a 3 semaines

    Paris 1er, France BIORASI LLC Temps plein

    **We are Growing**! Let us support your career journey the Biorasi way. Innovative, Collaborative, Dynamic and Evolving. Capitalizing on your strengths while encouraging work-life balance. Biorasi is an award-winning, customer-focused, full-service clinical research organization, and we are unlike any CRO you’ve ever heard of. Biorasi is looking for top...

  • Regulatory Affairs Compliance Officer

    Il y a 7 mois

    Paris, France JM Huber Corporation Temps plein

    **Summary**: **Key Responsibilities**: - Develop, implement, and manage regulatory strategies to ensure compliance with applicable regulations and standards. - Monitor changes in relevant regulatory environments, interpret new and existing regulations, and communicate potential impacts to key stakeholders. - Provide expert guidance on regulatory matters...

  • Senior Global Regulatory Affairs Specialist

    Il y a 7 mois

    Paris, France Novasyte Temps plein

    Job Overview Prepares and/or reviews regulatory submissions to support clinical trial and marketing authorisation activities for either internal and/or external clients. Independently provides regulatory support for more complex projects. Essential Functions - Acts as a Regulatory Team Leader on complex projects, which may include technical writing and/or...

  • Regulatory Affairs Intern

    Il y a 2 mois

    Paris, France Worldwide Clinical Trials Temps plein

    **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a...

  • Quality & Regulatory Affairs

    Il y a 3 mois

    Paris, France Implicity Temps plein

    **Job Summary** Joining the regulatory team, reporting to Head of Quality and Regulatory Affairs, your mission is to maintain the Quality Management System, with the objective of improving and automating processes - Your simply are the Quality Lead of Implicity - You then manage the roadmap and implement your plan regarding our ISO 13485 certification - You...

  • Local Regulatory Affairs Associate

    il y a 2 semaines

    Paris, France ICON Temps plein

    Prise de poste non définie BAC +3/+4 Paris Nombre de postes non défini CDI À négocier **Description du poste et des missions**: **ICON plc recrute un Local Regulatory Affairs Associate (LRAL) à Paris et sa région** **_ ROLE:_** L'équipe Global Regulatory Clinical Services (GRCS) d'ICON Biotech Solutions aide les clients d'ICON à naviguer dans les...

  • Regulatory Affairs Specialist Emea

    il y a 2 semaines

    Paris, France International Flavors & Fragrances Temps plein

    IFF applies expert science to advance market-driven, healthy and sustainable solutions for the food, beverage, dietary supplements, and many other industries. IFF is growing and we are looking for a dedicated and passionate individual to join our Regulatory Affairs team in EMEA! In the Regional Regulatory Affairs Team in EMEA we have an opening for a...