![Novartis Farmacéutica](https://media.trabajo.org/img/noimg.jpg)
Global Regulatory Submission Manager
2 weeks ago
Our Development Team is guided by our purpose: to reimagine medicineto improve and extend people's lives.To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patientseven faster.We are seeking key talent, like you, to join us and help give people with disease and their families a brighter future to look forward to.Apply today and welcome to where we thrive togetherThe Role:This role offers hybrid working, requiring 3 days per week in our White City, London office.As Global Regulatory Submission Manager you will be responsible for managing the delivery of cross functional submission documentation, overseeing publishing activities and the dispatch of compliant, worldwide regulatory submissions in support of Novartis global product portfolios.
About the RoleMajor accountabilities:
You will manage multiple and simultaneous global regulatory submissions projects in eCTD and non- eC TD formats,
You will driv e and ensure timely delivery of submission components by supporting cross functional teams .
You will provide guidance to project teams on worldwide HA submission requirements, filing strategy, document lifecycle management and compilation workflows, tracking timely delivery, reviews and approvals.
You partner across functions, troubleshoot submission technical / quality issues and manage the efficient use of resources.
You will organize, lead and facilitate / participate in both internal and external stakeholder meetings.
Your Experience:
Bachelor's degree in life sciences or relevant discipline.
R egulatory affairs or regulatory submissions related experience in global regulatory formats and submissions publishing activities.
Familiarity with the drug development process, global HA regulations/ guidance e.g. FDA, ICH, EMA .
Strong interpersonal skills and experience working in a complex, cross functional organization.
Fluency in English.
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 team's representative of the patients and communities we serve.
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?
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
Division Development
Business Unit Pharmaceuticals
Location United Kingdom
Site London (The Westworks)
Company / Legal Entity GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd.
#J-18808-Ljbffr-
Global Regulatory Submission Manager
6 days ago
London, Greater London, United Kingdom Novartis Full timeREQ Jun 14, 2024United KingdomSummaryOur Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives. To do this, we are optimizing and strengthening our processes and ways of working. We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our...
-
London, Greater London, United Kingdom Mosaic Regulatory Solutions Full timeRole - Principal Regulatory Affairs Specialist Location - Hampshire or Remote ( must be based in UK or Europe ) Salary - Negotiable Role Status- Perm Scope: Supports Regulatory Affairs Project core team members on development teams, providing regulatory guidance, and project regulatory assessments. Liaises with internal functions such as Manufacturing,...
-
Regulatory Specialist and Senior Specialist
2 weeks ago
London, Greater London, United Kingdom Mosaic Regulatory Solutions Full timeWe Want You for Our Team! This global manufacturer is in search of an exceptional regulatory specialist with at least 5 years of experience in the regulatory field. If you are up for a challenge and ready to showcase your skills, this position might be the perfect fit! About the Company: Looking for a Senior Regulatory Affairs Specialist Focus on MENA...
-
London, Greater London, United Kingdom Elanco Tiergesundheit AG Full timeRegulatory Affairs Manager, Global Regulatory Affairs Pharmaceuticals, EU page is loaded Regulatory Affairs Manager, Global Regulatory Affairs Pharmaceuticals, EU Apply locations UK - Hook IT - Milano AT - Vienna BE - Antwerp ES - Madrid time type Full time posted on Posted 2 Days Ago job requisition id R At Elanco (NYSE: ELAN) – it all starts with...
-
Global Regulatory Compliance Manager
2 weeks ago
London, Greater London, United Kingdom Arthur Edward Full timeGlobal Regulatory Compliance Manager – London – £50-60, Do you have an eye for detail and accuracy, even in a fast-paced environment? Are you ready to create compliant products that captivate consumers? Join one of the world's fastest-growing and most influential beauty brands and take responsibility for regulatory compliance and all related...
-
Associate Director Global Regulatory CMC
2 weeks ago
London, Greater London, United Kingdom Discover International Full timeOur Client is a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative therapies that improve the lives of patients. Their commitment to excellence is reflected in our pioneering research, groundbreaking treatments, and unwavering dedication to quality and compliance for innovative medicines. Position Summary:The...
-
Regulatory Manager
2 weeks ago
London, Greater London, United Kingdom Precision for Medicine Full timePrecision for Medicine (CRO) are recruiting a Regulatory Manager to join our team, candidates can be based in the following countries: UK, Spain, Hungary, Slovakia, Serbia, Romania or Poland. The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan...
-
Ghs/clp Chemical Regulatory Affairs Specialist
2 weeks ago
London, Greater London, United Kingdom VRS Regulatory Full timeAn opportunity to join the Product Stewardship / Regulatory Compliance team at a global chemical business; you will ensure the compliance of globally sold, highly complex mixtures.Key duties will be SDS authoring, classifications, labelling, component compliance checks and providing regulatory advice to the technology, R&D, and customer service teams.This is...
-
Regulatory Affairs Manager
2 weeks ago
London, Greater London, United Kingdom i-Pharm Consulting Full timePosition:Regulatory Affairs ManagernLocation:Uxbridge (UK)nContract Length:6-month (View to extend)nWork Structure:Monday - FridaynPay Rate:Available on request - (Inside IR35)The new Regulatory Affairs Manager must be an individual who has proven experience within a CMC (Chemistry, Manufacturing & Controls) focused environment.The client is a leading global...
-
Regulatory Compliance Programme Manager
2 weeks ago
London, Greater London, United Kingdom Novartis Farmacéutica Full timeOur Development Team is guided by our purpose: to reimagine medicineto improve and extend people's lives.We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patientseven faster.We are seeking key talent, like you, to join us and help give people with disease and...
-
Regulatory Affairs Manager
2 weeks ago
London, Greater London, United Kingdom i-Pharm Consulting Full timePosition: Regulatory Affairs ManagerLocation: Uxbridge (UK)Contract Length: 6-month (View to extend)Work Structure: Monday - FridayPay Rate: Available on request - (Inside IR35)The new Regulatory Affairs Manager must be an individual who has proven experience within a CMC (Chemistry, Manufacturing & Controls) focused environment.The client is a leading...
-
Regulatory Affairs Manager
2 weeks ago
London, Greater London, United Kingdom ICON Strategic Solutions Full timeRegulatory Affairs Manager- (EU CTR) Homebased in UK/Ireland OnlyDue to recent success within one our Innovative Biotech Clients I am recruiting for a Regulatory Affairs manager at ICON - Working in a client-dedicated yet fully embedded role ICON's Regulatory Strategy group, you will lead or contribute to the development and execution of the drug development...
-
Regulatory Affairs Associate
2 weeks ago
London, Greater London, United Kingdom Novartis Farmacéutica Full timeRegulatory Publishing Associate or Specialist Job ID REQ Our Regulatory Operations Team is guided by our purpose: to reimagine medicineto improve and extend people's lives.We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patients even faster.We are seeking key...
-
Senior Regulatory Affairs Program Manager
2 weeks ago
London, Greater London, United Kingdom Novartis Farmacéutica Full timeSenior Global Program Regulatory Manager Job ID REQ Our Development Team is guided by our purpose: to reimagine medicine to improve and extend people's lives.We are investing in new technologies and building specific therapeutic area and platform depth and capabilities – all to bring our medicines to patientseven faster.We are seeking key talent, like...
-
London, Greater London, United Kingdom Ultragenyx Pharmaceutical Full timeWhy Join Us? Be a hero for our rare disease patients_Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth - so employees can thrive in all areas of their lives, in and outside of work....
-
Regulatory Affairs
2 weeks ago
London, Greater London, United Kingdom i-Pharm Consulting Full timeRegulatory Affairs Manager CMCDuration: 6 month Contract Inside IR35Location: Uxbridge, 3 days on-site per weekHourly Rate: £40-£55 per hour dependent on experience.This role focuses on the critical aspect of Chemistry, Manufacturing, and Controls (CMC) within regulatory affairs.Responsibilities include:Leading global regulatory strategies with a strong...
-
Regulatory Scientist
2 weeks ago
London, Greater London, United Kingdom Orchard Therapeutics Full timeLocation: London, UK (or Boston, US)Reporting to: Director, Regulatory Science Early-Stage Programs Job SummaryThis role will report to the Director, Regulatory Science for Early-Stage programs. The successful candidate will have the opportunity to primarily work with Global and Regional Regulatory Leads who are responsible to develop the regulatory strategy...
-
Senior Regulatory Affairs Manager
2 weeks ago
London, Greater London, United Kingdom The RFT Group Full timeDevice Regulatory Affairs, Senior Director This is a rare opportunity to join a young, exciting clinical-stage biotechnology company. Our client is focused on the discovery and development of novel therapies, with the potential to fundamentally change the course of progressive, debilitating diseases. With an impressive proven track record of success in...
-
Regulatory Affairs Specialist, Clinical Trials
1 month ago
London, Greater London, United Kingdom The George Institute for Global Health Full timeClosing Date: Thursday 30 May at 5pm GMT.REPORTING RELATIONSHIP: Director Global Project OperationsTEAM/PROGRAM: Academic Project OperationsFULL TIME EQUIVALENT: 1 FTECAREER STEP: Specialist (Projects)EMPLOYMENT DURATION: Per contract (2-3 years)START DATE: ASAPAbout The George Institute for Global HealthThe George Institute for Global Health was established...
-
Global Head of Markets and Regulatory Operations
2 weeks ago
London, Greater London, United Kingdom Citi Full timeThe role forms part of Citi ICG Operations leadership team and is responsible for the management and oversight of all the ICG Operations functions supporting Global Markets as well as the Regulatory (Reg) reporting team, performing trade and transaction reporting.This role is being created as a result of consolidating two existing functions to ensure more...