Regulatory Affairs Associate

**_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...

**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...

Experience: 8 to 20 YearsLocation: Bangalore OR RemoteSkills: Regulatory Affairs, Clinical trial application, Clinical Trial Regulation, CDSCO10+ yrs relevant experience in Clinical Trial Regulatory Submissions.Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.Expertise in handling...

**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...

Experience: 8 to 20 Years Location: Bangalore OR Remote Skills: Regulatory Affairs, Clinical trial application, Clinical Trial Regulation, CDSCO10+ yrs relevant experience in Clinical Trial Regulatory Submissions.Experience in managing clinical trial studies, playing Regulatory Leads for Global trials, and exposure to the European market.Expertise in...

**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...

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation,...

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation,...

Title: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a...

**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...

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,...

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...

**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...

**Internal Title**:Regulatory Affairs Professional **External Title**:Deputy General Manager **Position Summary** To perform regulatory tasks as applicable to SHPL products pertaining to regulating authorities like radiation safety related certification from Atomic Energy Regulatory Board (AERB) for Zone India (India, Bangladesh, Nepal, Sri Lanka &...

**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...

**Responsibilities**: - Work closely with Engineering team through product development process and design activities - Author/participate in the design validation and process validations, IQ, OQ, PQ. - Prepare, review risk management files and support risk management activities including hazard analysis and FMEA. - Identify relevant guidance documents,...

Project Kuiper is an initiative to launch a constellation of Low Earth Orbit (LEO) satellites that will provide low-latency, high-speed broadband connectivity to unserved and underserved communities around the world. This is a unique opportunity to work in the development of a global broadband satellite communication system and make a difference in bridging...