Specialist- Regulatory Affairs

**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 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...

**_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...

REGULATORY SPECIALISTAt Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...

REGULATORY SPECIALISTAt Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...

REGULATORY SPECIALISTAt Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...

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...

**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...

**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 &...

REGULATORY SPECIALIST At Tag, we help brands stand out and sell more by delivering impactful content, at speed and scale and across channels & geographies. With over fifty years of production experience for some of the world’s biggest brands, we partner with our clients to create work that is efficient, effective and more importantly tells a story.We...

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...

**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,...

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...

**Lab/Affiliation**:UTSAAH Lab, CPDM, Indian Institute of Science, Bangalore **Project**: Ikshana - An integrated system for adaptive stimulation treatment of urinary incontinence - (ikshanahealthcare.co.in)_ **___________________________________________________** **OPEN POSITION: Internship - Regulatory Affairs** **Desirable Qualifications**: Final year...

About Halma:Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US.Our diverse group of nearly 50 global companies specialise in market leading technologies that push the...

**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...

Responsible for collating and compiling the dossiers for filing in different International markets like Africa, Asia, Latam, CIS & EU markets as per Relevant Regulatory guidelines of Pharmaceutical dosage forms like Tablets/Capsules/Dry syrup/Liquid syrup/Sterile Injectables (powder & liquid) /Ophthalmic/Semi solid preparations. Co-ordinating with...

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...

**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...