Global Program Regulatory Manager

Vor 5 Tagen

Basel, Schweiz Novartis Vollzeit

1,800+ associates. 86 countries. One Regulatory Affairs. At Novartis your voice, experience, and quality mindset can truly make a difference in Regulatory Affairs (RA). Novartis has a unique and promising portfolio with 70 projects as potential NMEs in development, 65 projects in Phase 3 or already undergoing registration, and 100 Phase 1/2 projects. We also focus on rare disease areas; in fact, more than 80% of our innovation is targeted on areas of high unmet need. In many cases, we can offer family friendly work flexibility to facilitate your physical and mental health. Read on to learn about the role available in Regulatory Affairs. We hope you will consider joining our global OneRA family.- Your responsibilities will include:
- Responsible for implementing regulatory strategy and managing operational activities for assigned regions.
- Provide input into global regulatory strategy and contribute to Regulatory Functional Plan (RFP) and Seed Documents, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
- Partner with regions to align on regulatory strategy in order to fulfil business objectives. Implement RFP across assigned regions.
- Facilitate preparation and finalization of briefing books and contribute to preparation of summary documents.
- Develop and implement plans for timely response to HA requests and coordinate responses. May serve as local HA liaison depending on location (e.g., FDA or EMA).
- Coordinate, review, submit Clinical Trial Applications (CTAs) and Amendments.
- Lead key maintenance activities for approved products for your assigned region including the coordination and submission of variations, periodic safety update reports, RMPs. Support line extension submissions.
- May lead negotiations for regional approvals independently or with RA GPT representative and/or GTAL. Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the RA GPT representative and/or GTAL.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- What you’ll bring to the role:
- Experience in working with cross-functional teams across different cultures in a virtual environment
- Excellent communication skills, both verbal and in writing
- Fluency in English
- Experience in coordinating Clinical Trial Applications for multi-national clinical studies
- At least 1-2 years of experience in Regulatory Affairs for development and marketed products, preferably in respiratory indications (asthma, COPD)
- University degree in life sciences. PharmD, PhD or MD is an asset.

Why consider Novartis?
- 799 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
- We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
- Imagine what you could do at Novartis
- Commitment to Diversity & Inclusion:

- Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.-
**Division**
- Global Drug Development**Business Unit**
- REG AFFAIRS GDD**Country**
- Switzerland**Work Location**
- Basel**Company/Legal Entity**
- Novartis Pharma AG**Functional Area**
- Research & Development**Job Type**
- Full Time**Employment Type**
- Regular**Shift Work**
- No**Early Talent**
- Yes

  • Global Program Regulatory Manager

    vor 7 Monaten

    Basel, Schweiz Novartis Vollzeit

    394918BR **Global Program Regulatory Manager (GPRM - Cardiometabolic)**: Switzerland **About the role** 26 major approvals, 13 major submissions and 2,000 associates worldwide. That was Regulatory Affairs in 2020. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing...

  • Global Program Regulatory Director

    Vor 7 Tagen

    Basel, Schweiz Sandoz Vollzeit

    1996! In this year Sandoz initiated the world’s first biosimilar development program. Over 20 years of experience in biosimilar development have equipped us with extensive knowledge and outstanding expertise in the development, manufacturing and commercialization of biosimilar medicines to the healthcare community and patients worldwide. - Global Drug...

  • Global Program Manager

    Vor 7 Tagen

    Basel, Schweiz We make it Vollzeit

    Beschreibung: We make it GmbH is a nationally active company in Switzerland with a high level of expertise in the field of personnel services thanks to many years of successful experience. Concentration of placement activities on the core areas of industry, technology, office/administration, engineering, pharmaceuticals and IT. We make it GmbH places the...

  • Global Program Regulatory Manager

    vor 21 Stunden

    Basel, Schweiz Novartis Vollzeit

    26 major approvals, 13 major submissions and 2,000 associates worldwide. We are a culturally diverse, global team of talented professionals seeking to leverage the voices of our patients in our approach to bringing potentially life-changing therapies to people who need them. Novartis has a robust pipeline, including possible treatments for rare disease...

  • Head of Global Regulatory Strategy, Immunology

    vor 2 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Head of Global...

  • Manager, Global Regulatory Science

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Patient Access Program and Supply Lead

    vor 1 Woche

    Basel, Schweiz Global Kader Personal Vollzeit

    **INTRODUCTION**: As a preferred supplier for Roche Basel, we are looking for an individual as **Patient Access Program and Supply Lead**: - (contract for one year duration, with possible extension). The earliest start date is within one to two month. Remote/Homeoffice: mixed set up but onsite required too. **ASSIGNMENT DESCRIPTION**: - Takes the lead in...

  • Associate Director, Global Regulatory Science

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Manager, Regional Regulatory Strategy

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the...

  • Manager, Regional Regulatory Strategy, Infectious

    Vor 3 Tagen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the...

  • Manager, Regulatory Affairs, International

    vor 2 Wochen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Manager, Regulatory...

  • Submissions Manager, Regulatory Operations

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Regulatory Operations Submission Manager is responsible for the planning, managing and tracking of regulatory submissions. In collaboration with the Regulatory Lead, he/she plans and prepares high quality global submissions, in-house or via CRO, ensuring delivery of compliant submissions to global health authorities in a timely manner. The...

  • Global Program Clinical Head

    vor 7 Monaten

    Basel, Schweiz Novartis Vollzeit

    393119BR **Global Program Clinical Head - Neurosciences**: Switzerland **About the role** With more than 60-year history in neuroscience, Novartis brought landmark therapies to patients with Multiple Sclerosis, Alzheimer’s disease, Parkinson’s Disease, Epilepsy, Depression and Migraine. We have an extraordinary pipeline in neuro-inflammation,...

  • Global Program Clinical Head

    vor 1 Woche

    Basel, Schweiz Novartis Vollzeit

    10! That’s how many pipeline projects Immunology, Hepatology, Dermatology (IHD) has in Phase 3 or registration and over 25 projects in Phase 1/2. Our IHD Unit has a pipeline with depth and breadth and is known to be a talent powerhouse. We are uniquely positioned to have a critical impact on bringing innovative medicines to patients across multiple...

  • Manager, Regional Regulatory Strategy- Oncology

    vor 2 Wochen

    Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Director, Regulatory Affairs-Regional Regulatory Strategist, - EU & International. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and...

  • Manager, Regulatory Strategy, International

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: The Manager of Regulatory Strategy-International based in Basel, Switzerland will have the opportunity to provide regulatory support to the Senior Director, Regulatory Affairs Strategy, Infectious Disease. This is a newly created role intended for a forward looking, creative and agile regulatory manager able to anticipate and address the...

  • Global Regulatory Affairs Manager

    vor 2 Wochen

    Basel, Schweiz EDP Personalberatung Vollzeit

    **#Pharma #RegulatoryAffairs***: Our customer, a **pharmaceutical company based near Basel**, needs reinforcement. For a **temporary employment** **, **we are looking for a **Global Regulatory Affairs Manager (M/F/d), 100%**: **Jetzt bewerben** **Major accountabilities**: - Lead the joint efforts for the development of the global product approval...

  • Global Regulatory Affairs Coordinator

    Vor 4 Tagen

    Basel, Schweiz Sobi Vollzeit

    **Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.** **Global Regulatory...

  • Global Program Clinical Head

    vor 5 Monaten

    Kanton Basel-Stadt, Schweiz Novartis Vollzeit

    **Summary**: The Global Program Clinical Head (GPCH) is the global clinical leader responsible for one or more clinical programs across indications, involving one or multiple compounds. The GPCH owns the risk benefit assessment for the program(s), and as the leader of Global Clinical Team(s) (GCT) is accountable for the design, implementation, and execution...

  • Manager, Regulatory Strategy, International

    vor 7 Monaten

    Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...