Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist Job Summary: We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Piramal Critical Care. The successful candidate will be responsible for managing regulatory filings for Europe, ensuring compliance with eCTD requirements, and providing support to the Pharmacovigilance team. Key...

Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at 1925 GlaxoSmithKline LLC.About the RoleAs a Regulatory Affairs Specialist, you will be responsible for ensuring the development of appropriate Precision Medicine and Digital Health regulatory strategy(s) and their execution for assigned precision medicine and digital...

About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Genpact. As a Lead Regulatory Affairs Expert, you will play a critical role in ensuring compliance with labeling regulations and guidelines.Key ResponsibilitiesLiaise with key interfaces to ensure project requirements are met and timelines are mutually...

Job Title: Regulatory Affairs SpecialistKey Responsibilities:Ensure compliance with regulatory requirements for API Plant operations.Manage DMF compilation and lifecycle management.Coordinate change control and related submissions.Develop and maintain quality standards.Requirements:Qualifications:Minimum 2 years of experience in regulatory affairs or quality...

Regulatory Affairs Role OverviewCounselect Services Private Limited is seeking a skilled Regulatory Affairs Specialist to join their team. This role involves handling the regulatory function for drugs, cosmetics, and food products in both domestic and international markets.The ideal candidate will have knowledge of regulations such as the Drugs and Cosmetics...

**Job Overview:**The Regulatory Affairs Specialist will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, and collaborating with others in the organization to contribute to the success of the business.**Key Responsibilities:**Prepare Red Books for key...

About ITEX: As a global leader in producing high-tech medical and aesthetic devices, we are committed to innovation and excellence. Our company has offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, making us a truly international organization.Job Overview: As a Regulatory Affairs Specialist, you will play a crucial...

Business: Piramal Pharma Solutions Department: Corporate Regulatory Affairs Job OverviewWe are seeking a skilled Regulatory Affairs Specialist to join our Corporate Regulatory Affairs team at Piramal Pharma Solutions. In this role, you will be responsible for submitting regulatory dossiers for targeted markets as per business needs to support CDMO and Agile...

Business: Piramal Critical Care Department: Regulatory AffairsLocation: Kurla, MumbaiTravel: LowJob OverviewAs a Regulatory Affairs Specialist, you will be responsible for managing Regulatory Filings for Europe with minimal supervision.Key Stakeholders: InternalCountry manager, Plant, QA, Artwork department, Supply Chain, PVKey Stakeholders: ExternalHealth...

Job Summary:Sun Pharma Advanced Research Company Ltd. is seeking a highly skilled Regulatory Affairs Specialist to support the development and execution of regulatory strategies for our pharmaceutical products. The ideal candidate will have a strong background in CMC regulatory affairs and excellent communication skills.Key Responsibilities:Authoring CMC...

Job Overview: We are seeking a highly skilled Medical and Regulatory Affairs Specialist to join our team at Piramal Group. The successful candidate will be responsible for providing scientific inputs for new product development, reviewing and approving product claims, conducting claim substantiating studies, and providing scientific training for marketing...

Job Summary:We are seeking a highly skilled and experienced Regulatory Affairs Specialist to play a key role in preparing and submitting regulatory documents for US, EU, UK, and Emerging Markets, ensuring compliance with all relevant guidelines and regulations.This role requires strong communication skills, attention to detail, and the ability to collaborate...

Job Title: Regulatory Affairs ExecutiveIpca Laboratories Limited is seeking a highly skilled Regulatory Affairs Executive to join our team.Key Responsibilities:Develop and implement regulatory strategies to ensure compliance with US FDA guidelines.Prepare and submit registration dossiers, renewal applications, and variations as per regulatory...

About the RoleWe are seeking a highly skilled Regulatory Affairs Consultant to join our team at Parexel.As a Regulatory Affairs Consultant, you will be responsible for handling the life cycle management of approved drug products, including tablets, syrups, and parenterals.You will lead and contribute to the planning, preparation, and delivery of regulatory...

About ApotexApotex is a global health company that produces high-quality, affordable medicines. The company employs almost 7,200 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in over 75 countries. Through vertical integration, the Apotex group focuses on developing and selling generic,...

About Apotex Inc.Apotex Inc. is a Canadian-based global health company producing high-quality, affordable medicines for patients worldwide. With almost 7,200 employees globally, Apotex operates in manufacturing, R&D, and commercial operations.Job SummaryWe are seeking a skilled Regulatory Affairs Specialist to perform labelling update and maintenance...

About this RoleParexel is seeking a highly skilled Senior Regulatory Affairs Associate to join our team in a labeling specialist role. This individual will be responsible for ensuring compliance with key labeling regulations and guidelines.Key ResponsibilitiesCollaborate with cross-functional teams to ensure accurate and compliant labeling.Develop and...

We are seeking a highly skilled Regulatory Affairs Specialist to join our Quality team at 1054 GlaxoSmithKline Services Unlimited.The successful candidate will be responsible for ensuring compliance with global, regional and national regulatory requirements and GMP guidelines, including risk management. Key responsibilities include:Managing operations to...

Key ResponsibilitiesAs a Regulatory Affairs Specialist at Talent Corner, you will be responsible for managing CTD/ACTD Row market documentation, filing with the MOH for herbal/pharma products, particularly CIS. You will also oversee product label artworks, FDA licenses/COPP, and technical documentation. Additionally, you will coordinate export COA and...

Job OverviewThis position is responsible for handling and maintaining product compliance throughout the product lifecycle. The Regulatory Affairs Associate will work closely with the Regional Regulatory Affairs Department to ensure compliance with registration and regulatory requirements in Europe and North America.Key ResponsibilitiesSupport the regional...