Regulatory Coordinator

390689BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into Regulatory Information Management System (RIM) (e.g. DRAGON). Provide support as needed for routine...

394724BR **Regulatory Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA...

**Summary**: - Contributes and support the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Supports all registration activities of the Department to ensure compliance with the requisites of the local pharmaceutical regulatory environment. **About the Role**: **Major...

The purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This role is responsible for the operation of the regulatory systems and processes used to prepare...

CTD Dossier Drafting (Modules 2, 3, 4) - Regulatory writing - Clinical Regulatory & Pharmacovigilance Regulatory - Regulatory commitment & compliance - Any other Regulatory activities on need basis - Support Line manager & Matrix manager in Regulatory projects - Coordination and interaction with cross-functional teams Mandatory Skills Effective...

Job Purpose: The purpose of this role is to manage the regulatory information management (RIM) system for all Consumer Healthcare products worldwide to support key regulatory processes and enable the company to meet its regulatory, legal and pharmacovigilance obligations. This role is responsible for the operation of the regulatory systems and processes used...

**Summary**: - Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in...

**Location**:Hyderabad **Essential Duties & Responsibilities**: - Identify new business opportunities like Green Hydrogen, Storage etc. and study the tender documents pertaining to the same. - Prepare summaries of tenders and identify important clauses having techno-commercial impact. - Attend pre bid meetings organized by Project implementing Agencies and...

Some careers have more impact than others. If you’re looking for a career where you can make a real impression, join HSBC and discover how valued you’ll be. HSBC is one of the largest banking and financial services organizations in the world, with operations in 62 countries and territories. We aim to be where the growth is, enabling businesses to...

390691BR **RA Coordinator**: India **About the role** Your responsibilities include, but are not limited to: - Independently manage and prepare routine Health Authority submissions including Annual Reports, DSUR, New Protocol Submissions, Protocol Amendment, and New Investigator Submissions to ensure timely submissions in accordance with the FDA...

Join Our Team as a Regulatory Documentation SpecialistBristol Myers Squibb is seeking a highly skilled Regulatory Documentation Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for coordinating and authoring complex documents required for regulatory submissions. Your expertise will ensure the coordination...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...

Position Title: Associate, Regulatory Affairs Reports To: Director, Regulatory Affairs Location: Hyderabad, Telangana, India POSITION DESCRIPTION The RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory...

Job Summary:The Regulatory Submissions Specialist will be responsible for coordinating and managing the submission process for Investigational, Marketed Applications submissions. This includes preparing Cover Letters, FDA Forms, and submission content plans, as well as facilitating submission team meetings and coordinating non-eCTD submissions.Key...

Job SummaryAs a Regulatory Portfolio Manager at Bristol Myers Squibb, you will play a critical role in ensuring compliance with global regulatory requirements for our pharmaceutical products. This position involves coordinating with cross-functional teams, including regulatory affairs, quality assurance, and clinical operations.Key ResponsibilitiesLead the...

Position Title: Associate, Regulatory AffairsReports To: Director, Regulatory AffairsLocation: Hyderabad, Telangana, IndiaPOSITION DESCRIPTIONThe RA Associate will prepare regulatory submissions for generic drug products and actively participate in the management of submissions under regulatory agency review to fulfill Canadian regulatory requirements.KEY...