Insurance Regulatory Submission Expert

Regulatory Submission Expert Job Description: As a Regulatory Affairs professional, you will play a crucial role in ensuring the successful submission of regulatory documents for pharmaceutical products. This includes preparing and reviewing new ANDA filings, amendments, and Annual reports to the ANDA. Key Responsibilities: 1. Prepare and review regulatory...

Job TitleWe are seeking a highly skilled professional to join our team as a Regulatory Expert in the Power Sector.The ideal candidate will have a strong background in regulatory matters, with experience in financial and tariff modeling specific to the power sector.Develop and implement strategies to stay updated on energy policies, regulations, and...

Job Overview:The position of Regulatory Publishing Specialist is a key role in the preparation and management of BLA submissions in eCTD format using Veeva Vault eCTD Publishing. This involves compiling, formatting, and publishing regulatory documents according to global health authority requirements.Key Responsibilities:Prepare and manage BLA (Biologics...

review and prepare regulatory submissions, including new ANDA filings, amendments and Annual reports to the ANDAReview of DMF; Manages USFDA registration Provides technical review of data and reports to be incorporated into regulatory submissions;

DescriptionRegulator ChemistLocation: Chennai, IndiaRequired Language: EnglishEmployment Type: Full-TimeSeniority Level: AssociateTravel Mode: ModerateAbout UsBuckman is a privately held, global specialty chemical company with headquarters in Memphis, TN, USA, committed to safeguarding the environment, maintaining safety in the workplace, and promoting...

Job Description: Regulatory Affairs Executive (ROW Markets)Industry: PharmaceuticalsExperience: 3-5 YearsLoaction: ChennaiKey Responsibilities:Dossier Submissions: Compile & submit ACTD, CTD, and country-specific dossiers for ROW markets.Regulatory Queries: Prepare and respond to health authority queries on submitted dossiers.Document Review: Review BMR,...

Job Description Role - Regulatory Affairs - Medical DevicesExperience - 1 to 3 YearsLocation- Madhavaram, ChennaiBudget - As per the industryKey Responsibilities:1. Regulatory Submissions: Prepare and submit regulatory documents to authorities for approval, such as new product applications, amendments, and supplements.2. Compliance: Ensure products meet...

Regulatory Affairs PositionManage regulatory submissions, including new drug applications (NDAs), complete response letters (CRLs), information requests (IRs), and amendments to existing NDAs.File post-approval and prior approval supplements in compliance with FDA regulations.Review change controls to assess their impact on regulatory alignment and ensure...

Regulatory Affairs SpecialistThis is a key role within our organization, responsible for ensuring compliance with regulatory requirements. The Regulatory Affairs Specialist will work closely with cross-functional teams to prepare and submit amendments and supplements for assigned products.Key Responsibilities:Amendment and Supplement Preparation: Prepare,...

Job Title: Regulatory Compliance SpecialistWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. The key objective of this role is to prepare, review, and maintain regulatory documents to ensure compliance with international guidelines and country-specific requirements.The role involves coordination with internal teams and...