Regulatory Affairs Process Manager
Vor 6 Tagen
Responsible for the development and implementation - including adequate training to staff, efficiency, gap assessment and continuous improvement and performance – as well as operational support of assigned regulatory processes, as applicable and in close collaboration with the Process Director and other functions as applicable, to ensure organizational readiness and compatibility with associated systems and technology and compliant with global regulatory requirements and Novartis standards.
About the RoleKey Responsibilities:
For assigned processes:
- Drive Business process creation, review by Process Review Committee (or equivalent), continuous improvement (including system, technology and automation needs to improve process performance). This includes developing, authoring/writing (as applicable) and maintaining procedural documents, establishing KPI and working with Training & Capability team members to provide associated functional training.
- Actively shepherd the process documents through the preparation process, self-author/write or provide guidance to author(s) on the content of a procedural document with respect to the process.
- In partnership with International / Regions and Policy, monitor and review emerging regulations and regulatory guidelines and analyze impact on Novartis regulatory processes.
- Contribute to inspections and internal audits as applicable.
- Provide direct input and expertise in the areas of process design, risk management, governance, organizational design and compliance.
- Pressure-tested and risk-mitigate plans for transition from old to new/revised processes.
- Ensure high level of connectivity, alignment, transparency and collaboration with Subject Matter Experts (SME) across RA and with other Development and corporate functions and departments, as required.
- In partnership with Systems team, incorporate technology portfolio deliverables into integrated transformation roadmap as well as any other non-drug development projects that have bearing on the broader transformation.
- Contribute to learning/training strategy for regulatory capability building, functional learning and learning technology.
Document Control Mastery: Ensure meticulous version control and accessibility of quality documents (eg. SOP, WP, BPG), adhering to industry standards.
SOP operational management: Example: (opening and completing the Change request in relevant system, sending draft SOP for QMS review, getting the SOP uploaded in eSOPS, etc.) to 'shepherd' the procedure through the procedure creation/update process.
Minimum Requirements:
- Life Science Degree or other University degree with equivalent experience.
- Regulatory and drug development experience.
- Strong knowledge on E2E process, supporting system, regulations and business change(s).
- Strong working knowledge of QMS, SOPs and compliance.
- Strong process authoring/writing capabilities.
- Technology-savvy – ability to leverage and use systems, technology and automation (including digital assistants and AI tools) to derive efficiency in processes.
- Ability to anticipate the impact of any change(s) from external and internal sources to the E2E process, to supporting systems and training.
- Ability to effectively contribute to teams in a matrix environment.
- Analytic, influencing, and communication skills.
- Ability to define metrics.
- Process simplification and optimization.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
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.
#J-18808-Ljbffr-
Process Excellence Manager Regulatory Affairs
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitAbout the Job:We are seeking a Regulatory Affairs Process Manager to drive business process creation, review, and continuous improvement. The successful candidate will be responsible for developing and implementing assigned regulatory processes, ensuring organizational readiness and compatibility with associated systems and technology, as well as compliance...
-
Senior Regulatory Affairs Manager
vor 1 Tag
Basel, Basel-Stadt, Schweiz Deloitte AG VollzeitFor our client, a leading provider of drug development and manufacturing solutions in the pharmaceutical and biotech industries, we are seeking a Senior Manager, Corporate Regulatory Affairs. This role will involve overseeing and harmonizing regulatory affairs processes across multiple sites, ensuring compliance with international...
-
Regulatory Affairs Process Strategist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob Description SummaryWe are seeking a talented Regulatory Affairs Process Strategist to join our team at the Healthcare Businesswomen's Association. As a key member of our regulatory operations team, you will be responsible for developing and implementing effective processes that drive compliance and excellence in our regulatory affairs function.About the...
-
Regulatory Affairs Manager
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitAbout the RoleWe are seeking a highly motivated and experienced Regulatory Affairs Manager to join our team. The successful candidate will be responsible for managing operational activities for assigned regions and providing input into global regulatory strategy.This role requires strong leadership and organizational skills, as well as the ability to...
-
Strategic Regulatory Affairs Manager
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Dr. Reddy's Laboratories VollzeitAbout Us: Dr. Reddy's Laboratories is a leading global pharmaceutical company dedicated to making a meaningful difference in the lives of patients around the world. Our mission is to deliver high-quality medicines and services that improve healthcare outcomes and enhance patient care. We are committed to innovation, quality, and customer satisfaction.We are...
-
Regulatory Affairs Process Manager
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob Description SummaryResponsible for the development and implementation - including adequate training to staff, efficiency, gap assessment and continuous improvement and performance – as well as operational support of assigned regulatory processes, as applicable and in close collaboration with the Process Director and other functions as applicable, to...
-
Process Excellence Manager
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob Overview:The Process Excellence Manager - Regulatory Compliance will play a critical role in driving process improvements and enhancing compliance across our regulatory affairs function. This individual will lead initiatives to streamline processes, eliminate inefficiencies, and ensure adherence to regulatory requirements.About the Position:Leverage data...
-
Regulatory Affairs Lead
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Talentify VollzeitRegulatory Affairs LeadWe are seeking a highly motivated Regulatory Affairs Lead to join our team. The successful candidate will be responsible for ensuring compliance with GMP regulations.Main Responsibilities:Conduct thorough reviews and approvals of analytical methods, method validations, specifications, risk assessments, deviation reports,...
-
Regulatory Affairs Strategist Director
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Dr. Reddy's Laboratories VollzeitAbout Us: Dr. Reddy's Laboratories is a rapidly expanding consumer healthcare business with a strong European presence. We are committed to delivering high-quality products and exceptional value to our customers. Our mission is to make a meaningful difference in the lives of patients around the world by providing innovative solutions that improve healthcare...
-
Global Regulatory Affairs Strategist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Dr. Reddy's Laboratories VollzeitGlobal Regulatory Affairs Strategist (New Product Developments)About Us: North Star is a rapidly expanding consumer healthcare business with a strong European presence. We are committed to delivering high-quality products/services and exceptional value to our customers. We are seeking a highly skilled and motivated Regulatory Affairs Strategist to join our...
-
Senior Process Analyst Regulatory Compliance
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Novartis Farmacéutica VollzeitAbout the Position:The Regulatory Affairs Process Manager plays a critical role in driving business process creation, review, and continuous improvement. The successful candidate will be responsible for developing and implementing assigned regulatory processes, ensuring organizational readiness and compatibility with associated systems and technology, as...
-
Global Regulatory Affairs Lead
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Dr. Reddy's Laboratories VollzeitAbout the Role: We are seeking a highly skilled Regulatory Affairs Strategist to join our dynamic team and drive the regulatory strategy for new product developments.We offer a collaborative and inclusive work environment where you can grow your career and contribute to the success of our organization. As a member of our team, you will be responsible for...
-
Director of Regulatory Affairs and Compliance
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Dr. Reddy's Laboratories VollzeitAbout Us: Dr. Reddy's Laboratories is a multinational pharmaceutical company committed to improving healthcare outcomes and enhancing patient care. Our mission is to deliver high-quality medicines and services that make a meaningful difference in the lives of patients around the world. We are seeking a talented Regulatory Affairs Strategist to join our...
-
Cell and Gene Therapy Regulatory Affairs Manager
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Bayer CropScience Limited VollzeitRegulatory Affairs OpportunityBayer CropScience Limited is seeking a Cell and Gene Therapy Regulatory Affairs Manager to join our team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with EMA, FDA, and other relevant regulations.ResponsibilitiesProvide CMC and QA expertise to CGT companies, ensuring...
-
Regulatory Compliance Specialist
vor 1 Tag
Basel, Basel-Stadt, Schweiz Deloitte AG VollzeitWe are looking for a Senior Manager, Corporate Regulatory Affairs to join our team at Deloitte AG. In this role, you will be responsible for overseeing regulatory affairs processes across multiple sites and ensuring compliance with international regulations.Key Responsibilities:Develop and implement regulatory compliance programs across all sites.Work...
-
Regulatory Affairs Specialist
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Coopers Group GmbH VollzeitCoopers Group GmbH is searching for an experienced Regulatory Affairs Specialist to support the development and implementation of regulatory strategies. This role involves working closely with cross-functional teams to ensure compliance with international regulations and guidelines.Your main responsibilities will include:Developing and maintaining regulatory...
-
Manager of Regulatory Operations
vor 24 Stunden
Basel, Basel-Stadt, Schweiz Deloitte AG VollzeitWe are seeking a highly skilled Senior Manager, Corporate Regulatory Affairs to join our quality assurance team at Deloitte AG. In this role, you will be responsible for ensuring regulatory compliance across our global operations and driving quality excellence in our life sciences business.Key Performance Indicators:Maintain a high level of regulatory...
-
Regulatory Affairs Professional
vor 21 Stunden
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitThe Job Description:We are seeking an experienced Senior Global Labeling Manager to join our team. The successful candidate will lead the development of global labeling strategies and ensure compliance with regulatory requirements. This role involves presenting proposed changes to stakeholders, researching regulatory guidelines, competitor labels, and...
-
Regulatory Affairs Specialist
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions VollzeitCTC Resourcing Solutions supports companies in finding top talent and provides reliable HR, consulting services, and skill development programs. Our network helps candidates advance their careers and stay competitive.Our client is a leading pharmaceutical company with a strong focus on novel therapies. They have a robust pipeline with multiple Phase II/III...
-
Senior Manager Global Regulatory Affairs
Vor 3 Tagen
Basel, Basel-Stadt, Schweiz Healthcare Businesswomen's Association VollzeitJob SummaryWe are seeking an experienced Senior Global Program Regulatory Manager to join our team. In this role, you will be responsible for developing and implementing regulatory strategies that support the launch of new products and the maintenance of existing ones.You will work closely with cross-functional teams to ensure compliance with regulatory...
