Senior Regulatory Affairs Associate-Biologics

Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...

Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution where patients come first. Our ambition is to impact a billion lives and we do this by fostering a culture of affordable innovation, patient centricity and disruptive thinking. We are a multicultural global company where...

At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...

Biocon Biologics is a fully-integrated ‘pure play’ biosimilars organisation globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is...

Biocon Biologics is a fully-integrated ‘pure play’ biosimilars organisation globally committed towards transforming patient lives through innovative and inclusive healthcare solutions. It is engaged in developing high-quality, affordable biosimilars aimed at expanding patient access to cutting-edge class of therapies across the world. Biocon Biologics is...

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...

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...

**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...

Regulatory Affairs Consultant:Around 7-10 years of relevant experience in handling of pre and post approval life cycle management of drug products (small molecules as well as biologicals) in various markets.Good understanding of regulatory framework, including regional trends, for various types of applications and proceduresLead and / or contribute to the...

At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...

At BBL we leverage cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. Intentional curiosity and an innate entrepreneurial scientific spirit fuel our strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other...

**_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 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...

**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...

**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...

Key Accountabilities:Project Execution:Regulatory Affairs Labeling Must have  4+ years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality. Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS,...

**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 DescriptionMedical Writer for Global Medical Centre of Excellence, Patient Value & InnovationAt Biocon Biologics, we are creating a model for the future of healthcare for all. We are a leading company in the biosimilars revolution, where patients come first. Our ambition is to impact a billion lives by fostering a culture of affordable innovation,...

**Key Accountabilities**: **Project Administration**: - Under supervision provide basic paper and electronic publishing services including document preparation, legacy conversion, scanning, rendering, bookmarking, hyperlinking, compilation, table of contents creation, volumization, pagination, and formatting of reports and simple submissions. - Provide...