Regulatory Affairs Specialist: Formulation and Submissions Expert

Job Description Overview:ScaleneWorks seeks a skilled Regulatory Affairs Specialist to lead our regulatory efforts. As a key member of the team, you will be responsible for ensuring the compliance of our products with relevant regulations.About the Role:This is an exciting opportunity to join ScaleneWorks as a Regulatory Affairs Specialist. You will be...

Job SummaryWe are seeking a seasoned Senior Regulatory Affairs Specialist to join our dynamic team at AliveCor. As a key member of the regulatory team, you will play a crucial role in overseeing medical device development and market introduction worldwide.Your primary responsibility will be to manage product submissions, perform regulatory pre- and...

**Job Summary:**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Dozee. This role will be responsible for ensuring compliance with local and international regulations, including US FDA, EU MDR, and ISO 13485.The ideal candidate will have a strong understanding of medical device regulations, experience with international...

Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Dozee. As a key member of our Quality Assurance department, you will play a critical role in ensuring the compliance of our medical devices with regulatory requirements.About the RoleThis is a fantastic opportunity for an experienced professional to leverage...

About the RoleWe are seeking a skilled Regulatory Affairs Specialist to join our team at Biocon. In this role, you will be responsible for preparing and reviewing regulatory documents, including ANDA submissions in the US market.Key Responsibilities:Document Preparation and Review: Prepare, review, and submit high-quality regulatory documents, such as ANDA...

Vantive: Revolutionizing Kidney Care Baxter is a leading healthcare company on a mission to separate our ~$5B Kidney Care segment into a standalone company, Vantive. With nearly 70 years of experience in acute therapies and home and in-center dialysis, we aim to provide best-in-class care to those we serve. The role of Regulatory Affairs Specialist Lead is...

Job Title: Regulatory Affairs Specialist for Medical DevicesLocation: Bengaluru, Karnataka, IndiaContract Type: Full-timeSeniority Level: Mid-Senior levelLifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. We connect talented professionals with opportunities in pharma, biotech, health sciences, healthtech and IT domains.Estimated Salary:...

Job SummaryWelcome to Dozee, a pioneering healthcare company seeking a seasoned Regulatory Affairs Specialist to spearhead our medical device compliance efforts. This is an exceptional opportunity for a highly motivated individual with expertise in navigating the complex landscape of medical device regulations.About the RoleWe are looking for a seasoned...

Company Overview:Dozee is a leading provider of AI-based contactless Remote Patient Monitoring (RPM) and Early Warning System (EWS) solutions for hospitals and home. Our innovative technology helps improve patient safety, reduce costs, and enhance continuum of care.About the Role:We are seeking an experienced Regulatory Affairs Specialist to join our team in...

We are looking for a Global Regulatory Affairs Expert to lead our regulatory development and compliance efforts in India. As a key member of our team, you will be responsible for aligning public affairs and regulatory priorities, communicating with stakeholders, and leading strategic initiatives related to regulatory affairs.The ideal candidate will have at...

Job Title Principal Regulatory Affairs Specialist About the RoleWe are seeking a seasoned Regulatory Affairs professional to lead our efforts in ensuring compliance with global regulations and standards for medical devices. As a key member of our team, you will be responsible for developing and executing regulatory strategies for new product development,...

About ElancoAt Elanco, we're a global leader in animal health. Our mission is to advance the health of animals, people, and the planet.Job SummaryWe're seeking a Regulatory Affairs Specialist to work with our cross-functional teams to develop regulatory strategies, oversee submission preparation, and meet reporting requirements for new animal drugs with...

Job Summary: Regulatory Affairs ExpertAbout Avenue Code:Avenue Code is a PE Fund with a global presence, seeking a highly skilled Regulatory Affairs Expert to join our team in Mumbai - Bandra.Key Responsibilities:Ensure complete compliance with all constituent documents of the Funds and regulatory requirements.PMM Audit and other Audits: Liaising with the...

Job Title: Regulatory Affairs SpecialistLocation: Bengaluru, Karnataka, IndiaContract Type: Full-timeSeniority Level: Mid-Senior levelAbout the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. In this role, you will be responsible for ensuring compliance with various food regulations and laws in...

Job Description:As a Medical Device Regulatory Affairs Specialist at Dozee, you will play a pivotal role in ensuring the company's products meet regulatory requirements. Your primary responsibility will be to plan, establish, and maintain a Quality Management System (QMS) in accordance with EN ISO 13485. This involves implementing regulatory strategies for...

Job Title: Regulatory Affairs SpecialistIn this role at Biocon, you will be responsible for handling regulatory affairs for pharmaceutical products in the US market. Your primary focus will be on preparing and submitting ANDA/ANDS applications to the FDA.Key Responsibilities:Hands-on experience in preparing, reviewing, and submitting ANDA/ANDS applications...

Job Description: As a key member of the MTC Group team, you will be responsible for ensuring the company's compliance with all applicable laws and regulations. Your expertise will be instrumental in maintaining a positive relationship between the company and government departments.Responsibilities:Serve as the primary point of contact between the company and...

**Job Overview:**Lifelancer is a leading talent-hiring platform in Life Sciences, Pharma, and IT. We connect top talent with exciting opportunities in pharma, biotech, health sciences, healthtech, data science, and IT domains.About the Role:We are seeking an experienced Business Regulatory Affairs Specialist to join our Life Sciences team. As a key member of...

Join a dynamic team as a Regulatory Affairs Manager - Global Asset Oversight Expert and contribute to the development of innovative medicines that improve patients' lives.**About Us**Lifelancer is a talent-hiring platform in Life Sciences, Pharma, and IT. Our mission is to connect talented professionals with exciting opportunities in these domains.**Job...

Vantive: Revolutionizing Kidney CareBaxter is transforming its Kidney Care segment into a standalone company, Vantive. This new entity will leverage Baxter's legacy in acute therapies and home and in-center dialysis to deliver best-in-class care to patients worldwide.As a Regulatory Affairs Specialist at Vantive, you will be part of a community driven to...