Associate- Regulatory Submission Support

We're seeking a highly skilled Regulatory Submission Specialist to join our team at Lilly. As a key member of our Regulatory Department, you will play a critical role in ensuring compliance with regulatory requirements and timely submission of documents to global regulatory agencies.Main Responsibilities:Manage Submissions: Prepare and submit regulatory...

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...

Improve Patient Lives with BaxterWe are on a journey to revolutionize kidney care and other vital organ support. Vantive, a new company built on our legacy, will provide best-in-class care to the people we serve.Key Responsibilities:Provide regulatory support for on-market products, including change assessment, variation planning, and submission...

At Genpact, we are seeking a skilled Regulatory Affairs Specialist to join our team. This role demands an experienced publisher with a demonstrated ability to execute responsibility in a highly regulated and process-driven environment.The ideal candidate will have a deep understanding of eCTD types of submissions and industry-standard publishing systems....

**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...

Description The Regulatory Adherence Associate will be responsible for the governance of Regulatory Assurance and Reporting across CB, IB and CRU including supporting the delivery of risk and control initiatives and participating in risk and control activities. They will work closely with Operations across multiple products and locations to ensure the...

Clinical and Regulatory Submissions Medical WriterAt ClinChoice, we are seeking a highly skilled Medical Writer to join our team.About the RoleThe Medical Writer will research, create, edit, and coordinate the production of clinical and regulatory submission documents, including clinical study reports, protocols, CTD sections, IB, and safety update...

**About AstraZeneca** At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of...

Company OverviewScaleneWorks is a leading pharmaceutical company dedicated to delivering innovative solutions in project management. Our team of experts works collaboratively to ensure timely and effective project delivery.SalaryThe salary range for this position is $160,000-$220,000 per year, depending on experience and qualifications.Job DescriptionWe are...

**Job Title - Associate - International CMC Regulatory Affairs** **Career Level - C** Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get...

Bengaluru, India **Job ID** 84359BR **Category** Regulatory / Consulting **ABOUT THIS ROLE**: **Experience: Biologic CMC** 2 years of experience Supported the CMC activities related to Vaccine/Biologic manufacturing and control including authoring of submission dossiers related to: - Understanding of EU/CA/WHO/US regulations & guidance allowing...

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...

Job TitleAssociate Director, Regulatory AffairsAbout the RoleParexel is seeking an experienced Associate Director, Regulatory Affairs to join our team. The ideal candidate will have a strong background in clinical trial regulatory submissions and leadership experience in managing clinical trial studies.Clinical Trial Regulatory Submissions: Over 15 years of...

Job SummaryAs a Regulatory Associate Manager II at ScaleneWorks, you will play a crucial role in ensuring the compliance and registration of our business activities. Your primary responsibility will be to oversee the preparation of registration files, briefing books, and other regulatory documents.Key ResponsibilitiesPrepare and maintain accurate and...

Associate Regulatory Professional II **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**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...

When our values align, there's no limit to what we can achieve.   Job Description: 4-6 yrs of experience in handling of pre and post approval life cycle management of Biologic products in various markets Regulated (EU/US/Canada) and Emerging Markets. Good understanding of regulatory framework, including regional trends, for various types of...

About VantiveVantive is a new company built on the legacy of Baxter, a leading healthcare company. We are on a mission to revolutionize kidney care and other vital organ support.Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for supporting all regulatory activities...

We're seeking a highly skilled Regulatory Publishing Specialist to join our team at Lilly. As a key member of our Regulatory Publishing team, you will be responsible for managing submissions, planning submission workloads, and partnering with regulatory associates to retrieve, publish, and submit modules 1-5 reports/documents and combine files into...

**Job Title: Regulatory Affairs Associate I** **Career Level - C** **Introduction to Role**: **Accountabilities**: As a Regulatory Affairs Associate, you will be responsible for document management, including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements. You will maintain...

Company Description We are the company that cares - for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those...