Senior Regulatory Specialist

Sr. Regulatory Compliance SpecialistThe primary objective of this role is to oversee and direct regulatory activities for submissions to the USFDA, encompassing preparation and review of technical documents, ensuring compliance with batch manufacturing records, process validation documents, and site-related data.

Job Title: Regulatory Compliance SpecialistKey ResponsibilitiesThe successful candidate will have a strong background in auditing, with a focus on regulatory compliance and enforcement.We are seeking a highly motivated individual to analyze system audit reports, review MIS for delays and non-compliance, and address ATR and follow-on issues.Required Skills...

**Compliance Professional - Regulatory Specialist**At our organization, our culture is built on a strong foundation of innovation, shared values, and leadership behaviors. As part of our team, you'll experience comprehensive support for your holistic well-being and many opportunities to learn new skills, develop as a leader, and grow your...

Regulatory Specialist Job DescriptionJob SummaryAs a Regulatory Specialist, you will be responsible for handling regulatory filings and ensuring compliance with frameworks in the power sector.Key ResponsibilitiesHandling ARR filings, tariff determination, petitions, and regulatory analysisDrafting and submitting regulatory petitions, compliance reports,...

Regulatory reporting specialists play a pivotal role in ensuring organizations meet regulatory requirements. We seek an experienced Regulatory Reporting Manager to join our team.The successful candidate will have 7+ years of experience in regulatory reporting, with a strong understanding of APRA / Basel 3 Credit risk calculation, reporting processes and...

Regulatory SpecialistWe are seeking an experienced professional to oversee regulatory activities and related developments across regions. This is an exciting opportunity to work within a dynamic team that manages supervisory activities of regulators and related developments.This role involves managing and coordinating regulatory examinations, overseeing...

Job Title: Senior Compliance ManagerAbout Us:We manage mutual funds, seeded with capital from our sponsor. Our company has launched schemes for retail investors and corporates.Key Responsibilities:Ensure compliance functions operate smoothlyMonitor regulatory adherence and implement policiesGuarantee accuracy and timeliness of submissions and disclosuresAs a...

Job OverviewWe are seeking a highly skilled Regulatory Publishing Specialist to join our team. This individual will be responsible for preparing and managing BLA submissions in eCTD format using Veeva Vault eCTD Publishing.">Key Responsibilities:Prepare and manage BLA (Biologics License Application) submissions in eCTD format using Veeva Vault eCTD...

Job Title: Compliance Assurance SpecialistAbout This RoleWe are seeking a highly skilled Compliance Assurance Specialist to join our team.Key Responsibilities:Compliance and ValidationHands-on experience in compliance and validation roles, with strong knowledge of GxP, GDPR, FDA, 21 CFR Part 11, and GAMP 5.System validation aligned with regulatory standards,...

Job Overview:We are seeking an experienced professional to lead Approvals & Coordination activities with various government departments.About the RoleThe ideal candidate should have a strong track record of obtaining necessary approvals and clearances while effectively liaising with multiple authorities.Key ResponsibilitiesManage and coordinate approvals...