Director of Global Regulatory Operations
Vor 2 Tagen
Regulatory Strategy Role
This role is responsible for developing and implementing global regulatory strategies to achieve business objectives. The ideal candidate will have a strong background in operations management, project management, and cross-cultural collaboration. The successful candidate will be responsible for driving coordination, planning, and submission of dossiers in assigned regions worldwide, reviewing global dossier summary documents, and developing and implementing plans to avoid/minimize clock stops during submission review. The ideal candidate will also have clinical trials, drug development, lifesciences, negotiation skills, and regulatory compliance experience.
Key Responsibilities:
- Develop and implement global regulatory strategies to achieve business objectives.
- Partner with regions to align on regulatory strategy and implement RFP across assigned regions.
- Determine requirements and set objectives for Health Authority (HA) interactions.
- Facilitate preparation and finalization of briefing books and contribute to summary documents.
- Develop and implement plans for timely response to HA requests and coordinate responses.
- Drive coordination, planning, and submission of dossiers in assigned regions worldwide.
- Review global dossier summary documents.
- Develop and implement plans to avoid/minimize clock stops during submission review.
- Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
- Reviews and submits Risk Management Plans.
Requirements:
- Functional breadth with experience in operations management, project management, and cross-cultural collaboration.
- Clinical trials, drug development, lifesciences, negotiation skills, and regulatory compliance.
-
Global Product Regulatory Lead
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitGlobal Regulatory Strategy Position OverviewWe are seeking an experienced regulatory professional to join our team as a Global Regulatory Strategy Director. In this role, you will be responsible for developing and implementing global regulatory strategies to achieve business objectives. The ideal candidate will have a strong background in operations...
-
Global Regulatory Strategy Director
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitAbout the JobThis role will oversee the development and implementation of global regulatory strategies for our product portfolio, ensuring timely submissions and approvals with the best possible labels based on available data. Key Responsibilities:Develop and implement global regulatory strategies to achieve business objectives.Partner with regions to align...
-
Basel, Basel-Stadt, Schweiz Lonza Biologics Porriño SLU VollzeitLonza's products and services have a positive impact on millions of people every day. Our company respects and protects our people and our environment. We believe that any success we achieve is no success at all if not achieved ethically.We are looking for a highly motivated Director, Local Lead Regulatory Affairs Advanced Synthesis to join our team. As a...
-
Regulatory Affairs Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob Description SummaryThis position requires a strategic thinker who can develop and implement global regulatory strategies to achieve business objectives. The ideal candidate will have experience in operations management, project management, and cross-cultural collaboration. Key responsibilities include developing and implementing global regulatory...
-
Global Director of ICT
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Noir Consulting VollzeitNoir Consulting is looking for a Global Director of ICT to lead our global IT function and drive business outcomes through strategic use of technology. This individual will be responsible for developing and implementing IT strategies that align with business objectives.Key responsibilities include:Developing and executing IT strategies that align with...
-
Director Advanced Synthesis Regulatory Strategy
Vor 5 Tagen
Basel, Basel-Stadt, Schweiz Lonza Biologics Porriño SLU VollzeitLonza is committed to improving lives all around the world. We offer the satisfaction that comes with making a meaningful difference through our work in life sciences.We are currently seeking a highly skilled Director, Local Lead Regulatory Affairs Advanced Synthesis to join our Advanced Synthesis Platform. As a key member of our team, you will be...
-
Global Program Regulatory Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob Description SummaryDirects the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite...
-
Global Program Regulatory Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica Vollzeit-Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending...
-
Global Regulatory Leader
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitJob DescriptionWe are seeking a highly skilled Global Regulatory Leader to join our team. The successful candidate will be responsible for directing the development and submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports.This role requires strategic thinking and the ability to provide expert...
-
Director of Quality Systems
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz BeiGene VollzeitJob DescriptionWe are seeking a highly experienced and skilled Director to lead our Quality Management System (QMS) efforts. The Senior Director, QMS Process Oversight and Performance will be responsible for the strategic oversight, leadership, and continuous improvement of the QMS.This role involves managing a team of cross-functional QMS Process Owners,...
-
Global Operations Director
Vor 7 Tagen
Basel, Basel-Stadt, Schweiz Roche VollzeitCompany OverviewRoche's Pharmaceutical Research and Early Development organization (pRED) is committed to transforming science into medicines. We strive to tackle the world's toughest unmet healthcare needs by creating a culture of curiosity, responsibility, and humility.Job DescriptionThe Global Head of Operations - NRD will be responsible for delivering...
-
Regulatory Program Director
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitJob Description:Global Regulatory Manager LeadThis role is responsible for developing and implementing global regulatory strategies for assigned regions. The primary goal is to ensure timely submissions and approvals with optimal labels based on available data.Main Responsibilities:Develops and implements global regulatory strategies.Identifies main Health...
-
Senior Global Program Regulatory Manager
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitSenior Global Program Regulatory ManagerJob ID REQ-10043957Mar 19, 2025Summary-Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates...
-
Head of Global Clinical Operations, Pharma Research
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Director of IT Operations Switzerland
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Noir Consulting VollzeitNoir Consulting is looking for a Director of IT Operations Switzerland to oversee our IT infrastructure and ensure seamless day-to-day operations in Basel. This role requires a strategic thinker who can balance business needs with technical requirements.Responsibilities include:Managing IT operations, including help desk support, network administration, and...
-
Global Labeling Operations Lead
vor 1 Stunde
Basel, Basel-Stadt, Schweiz Bell Food Group VollzeitBell Food Group is seeking a skilled Global Labeling Operations Lead to join their team. This role will be responsible for coordinating and managing activities related to the approval and maintenance of printed labeling components.The ideal candidate will have experience in developing regulatory content for printed labeling components, as well as a strong...
-
Technical Regulatory Program Director New Modalities
vor 3 Wochen
Basel, Basel-Stadt, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Director, Program Management, Global Commercial Operations
vor 15 Minuten
Basel, Basel-Stadt, Schweiz BeiGene VollzeitBeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. There may be instances where "BeiGene" or "BeOne" are used to describe the company during this transition period. BeOne continues to grow at a rapid pace with challenging and...
-
Global Regulatory Manager Lead
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitAbout the RoleDevelops and implements global regulatory strategies for assigned regions to ensure timely submissions and approvals with optimal labels based on available data.Identifies main Health Authority issues and participates in relevant regulatory Boards to provide valuable input.Participates in successful Health Authority interactions to achieve...
-
Basel, Basel-Stadt, Schweiz F. Hoffmann-La Roche Gruppe VollzeitAbout the RoleAt Roche/Genentech Pharma Product Development Global Clinical Operations (PDG), we are committed to transforming drug development and realizing our Pharma Ambition to deliver innovative medicines addressing diseases with high societal impact. We seek a highly skilled Clinical Operations Therapeutic Area Leader to lead and drive the delivery of...