Professional 1 Regulatory Publishing

We're seeking a skilled Regulatory Publishing Specialist to join our team at Lilly.Key Responsibilities: Manage submissions, including preparing submission cover letters and forms, and planning submission workloads. Partner with the Regulatory Associate to retrieve, publish, and submit Modules 1-5 reports/documents and combine files into electronic...

Job SummaryWe are seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our Regulatory Affairs department, you will be responsible for managing submissions, coordinating global registration activities, and ensuring compliance with regulatory requirements.Key ResponsibilitiesManage submissions, including...

Job SummaryWe are seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our publishing team, you will be responsible for managing submissions, planning submission workloads, and partnering with regulatory associates to retrieve, publish, and submit regulatory documents.Key ResponsibilitiesManage submissions,...

Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most...

At Elanco, we foster a collaborative and inclusive work environment that values diversity and champions innovation.We're seeking a skilled Regulatory Publishing Specialist to join our team.As a Regulatory Publishing Specialist, you will work closely with our Global Regulatory and R&D Organization to publish documents, manage processes, and develop positive...

We're seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly.Key Responsibilities:• Manage submissions, preparing cover letters and forms for regional review and approval.• Plan submission workload by reviewing the RDE RIM or Share Point Calendar for planned documents.• Partner with the Regulatory Associate to retrieve,...

Key Responsibilities:• Successfully meet and complete training milestones relevant to the position held.• Develop and maintain familiarity with FDA, GCPs, ICH guidelines, and the Life Sciences & Pharmaceutical industry.• Perform submission publishing, assembly, and distribution activities within the specified training period.• Notify relevant...

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables...

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success.As a Regulatory Publishing Specialist, you will work...

At Elanco, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets.We pride ourselves on fostering a diverse and inclusive work environment, where diversity is the driving force behind innovation, creativity, and overall business success.This role is responsible for working with multiple...

Successfully meet/ complete training milestones relevant to the position held. - Familiarity with FDA and ICH guidelines, Life Sciences & Pharmaceutical industry - Good knowledge on FDA, GCPs, ICH guidelines, Life Sciences and Pharmaceutical Industry. - Familiarity of health authority procedures / guidance regarding electronic submissions - Perform...

ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Operations Trainee on a permanent basis. You will work on projects from our varied client base,...

**Department**:RA CMC Biotech and Rare Disease **About the department** Regulatory Affairs plays an important role in ensuring all Novo Nordisk Medicines and Devices developed with compliance and keeping patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs will be involved throughout phases of product...

Regulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs** - Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment?...

Regulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Research & Development** - Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative...

We’re looking for people who are determined to make life better for people around the world. Manage submissions • Prepare Submission Cover letters and forms per appropriate regional submission and route for appropriate review and approval. • Plan submission workload by reviewing/monitoring the RDE RIM or Share Point Calendar for planned...

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

At Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose –...

Regulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**:RA CMC & Device**About the Department** - RA CMC & Device Bangalore in Global Business Services (GBS) Bangalore is a part of Bangalore Global Development hub consisting of high calibre regulatory professionals. The objective of the...

At Elanco (NYSE: ELAN) – it all starts with animals!As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose –...