Regulatory Submission

Key Responsibilities : Accountable to the GRL and Global Regulatory staff for the delivery of Marketing Application, pre-approval/investigational and lifecycle maintenance submissions to agreed timelines and in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices May be responsible for...

Key Responsibilities : Drive the submission and delivery process with the Global Publishing team to ensure timely dispatch and archival of submissions as per the agreed timelines. Delivery of submission packages to agreed schedule and technical specification Advise and assist authors with the preparation of submission content and use of GSK document...

Department: EU Submissions Hub Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to...

The position As Regulatory Professional, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include: Working closely with various submission teams across the organization and all countries in Europe Managing initial clinical trial application...

Department: EU Submissions Hub Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to join...

   Department: EU Submissions Hub Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to join...

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of...

Regulatory Affairs Consultant.8 years’ experience in handling life cycle management of approved drug products (small molecules) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation (including authoring where relevant)...

When our values align, there's no limit to what we can achieve.   Job Description: Relevant experience in regulatory package preparation, compilation and submission to Health Authorities in various markets  with focus on EU countries . Working knowledge of EU regulatory procedures including adaptability to strict Health Authority and Sponsor...

Job DescriptionYou will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research. Office-based in BangaloreOversee preparation of clinical trial submission dossiers for...

Job Description You will focus on leading regulatory services for global research projects of novel medicinal products in India while joining our global team of regulatory and ethics submissions experts. Join our team and contribute to groundbreaking clinical research.  Office-based in Bangalore Oversee preparation of clinical trial submission...

Regulatory Affairs Consultant.8 years' experience in handling life cycle management of approved drug products (small molecules) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation (including authoring where relevant) and...

8+ years' experience in handling life cycle management of approved drug products (like- tablets (oral solids), syrups (oral liquids), parenterals (injections/ injectables for EU market.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the planning, preparation...

The position As a RA Specialist, the ideal candidate will be responsible to design RA Strategy from late stage development and throughout Life cycle of the device project, prepare and submit high quality files to the authorities achieving fast approvals. Act as an ambassador for assigned medical devices/device part of combination products. This role...

**Department: Clinical Medical Regulatory (CMR)** Do you want to be a part of a high performing team in Novo Nordisk that plays a critical role in driving the success of the business? Do you have what it takes: the right drive, a sharp mind, customer orientation, openness and focus on what matters and a genuine interest in working with people? If you find...

Department: Regulatory Affairs Rare Endocrine Disorders Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies? We...

About the roleRole holders provide communications expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level with occasional contributions to communication strategy development at a program level. They contribute to improvement projects.Typical AccountabilitiesThe Clinical...

Department: Regulatory Affairs Rare Endocrine Disorders Job Level: 7 Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory...

About the roleRole holders provide communications expertise by leading teams in the delivery of high-quality clinical regulatory documents. They work primarily at the document development level with occasional contributions to communication strategy development at a program level. They contribute to improvement projects.Typical AccountabilitiesThe Clinical...

Department: Regulatory Affairs Rare Blood Disorders Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight...