International Cmc Regulatory Affairs Associate

**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...

**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...

**Job Title - CMC RA Associate I Submission Excellence & Project Management.** **CAREER LEVEL: C** **ABOUT ASTRAZENECA** AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more...

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 –...

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 –...

**Job Title: Regulatory Affairs Associate I (International Regulatory Affairs)** **Career Level - C** **Introduction to Role**: Within International Regulatory Affairs, as Regulatory professionals, we take innovative regulatory approaches to bring life-changing medicines to patients in international markets. We work across the AZ pipeline and business to...

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...

Senior Manager – Global Regulatory AffairsLocation – Head-Office, Bangalore, INAccountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products.12+ years experience is mandatoryResponsible for:Development and Implementation of regulatory strategies for global registrations...

Who we areTogether, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic...

**_Regulatory Affairs Associate _**: **Experience: RIM**: **Relevant experience in Regulatory and should be willing to work in EU Shifts (12:00 - 9.00 PM)**: - **Experience of handling RIM tools - Veeva Vault specifically.**: - **Basic Regulatory knowledge on regulations and Health Authorities.**: - **Excellent communication skills.** **Knowledge and...

**JOB TITLE: Regulatory Affairs Associate II**: **CAREER LEVEL: C**: **Leverage technology to impact patients and ultimately save lives** **ABOUT ASTRAZENECA**: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s...

Job Description - Regulatory Affairs AssociateYour mission, if you choose to accept, will be :ResponsibilitiesParticipate in the development of regulatory submission and approval strategy in multiple countries.Ensure compliance with FDA, ISO 13485, MDR, and other relevant regulatory requirements.Maintain awareness and understanding of new and existing...

Job Description - Regulatory Affairs AssociateYour mission, if you choose to accept, will be :ResponsibilitiesParticipate in the development of regulatory submission and approval strategy in multiple countries.Ensure compliance with FDA, ISO 13485, MDR, and other relevant regulatory requirements.Maintain awareness and understanding of new and existing...

**About Us**: An established player in the B2B Pharma raw material space has recently launched an exciting new E-commerce platform **- CLYZO** **Position - Regulatory Affairs Associate.** An organization with a reputed history of 10+ years in the Pharma raw material industry, dealing in excipient products is looking for Regulatory Affair Executive having...

**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...

**JOB TITLE: Regulatory Affairs Associate II**: **CAREER LEVEL: C**: **Leverage technology to impact patients and ultimately save lives** **ABOUT ASTRAZENECA**: AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s...

Regulatory Professional I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN- .- **Department**:RA CMC Diabetes & Obesity**About the department** - RA CMC & Device Bangalore is an integral part of RA CMC & Device and comprised of +60 experienced professionals associated with key regulatory processes covering Chemistry...

**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**: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...

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?...