Keeps abreast of regulatory compliance issues and assists in developing new Regulatory Department procedures, as needed. Prepare, assemble, review and/or evaluate, publish and archive new ANDA and life cycle management regulatory submissions in accordance with local regulatory requirements and guide...
The Senior Associate will be tasked with the organization, management, and execution of regulatory CMC projects, ensuring the successful support of regulatory submissions. Job Title: Senior Associate Regulatory Affairs – CMC. We are seeking a dedicated and experienced Senior Associate for their Regu...
Corporate/Regulatory Associate. Our corporate/commercial health practice offers general counsel, health regulatory and governance advice to healthcare organizations, associations and professionals. We provide strategic advice and regulatory opinions on a wide variety of issues. ...
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing and executing on regulatory CMC projects in support of...
We are supporting a small growing biotech in the Bay Area looking for a Senior Regulatory Affairs Associate!. Atleast 2 years experience in a regulatory setting at a biotech company. Strong foundation in biological or physical sciences, with the ability to apply scientific knowledge to regulatory ma...
Someone who has good knowledge of Regulatory Affairs/Compliance. ...
Associate) Director, Regulatory Affairs – Permanent – San Francisco Bay Area. Proclinical is seeking an (Associate) Director, Regulatory Affairs for a clinical-stage biopharmaceutical company located in the San Francisco Bay Area. A degree in a life science, chemistry, or chemical engineering or clo...
Job Title: Senior Associate, Regulatory Affairs. Join our Regulatory Affairs team as a Senior Associate and contribute to our ongoing projects. Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Provide Subject Matter Expertise in Veeva Vault Configuration and...
Job Title: Regulatory Affairs Senior Associate. Join our dynamic, global team as a Senior Associate in Regulatory Affairs. You'll be working closely with our Regulatory Information Management and Systems (RIMS) team, contributing to our mission of delivering regulatory systems and processes that ens...
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Assist Regional Regulatory Represen...
The Human Resource Compliance Analyst is responsible for assisting in the development, implementation, and administration of a centralized HR compliance monitoring program designed to align HR policies and practices with applicable laws, regulatory requirements, and in support of the company busines...
Business Process Owner for Audits and Inspections Sets the requirements for the Self Inspection Program Defines the Self Inspection Schedule Manages training for Internal Auditors Supports training for external inspection support staff Develop a pool Quality Control, Internal Auditor, Compliance, Sp...
Prepares regular project status reports to keep both managers and key stakeholders up to date on all issues and aspects of the project. Manages outsourced projects by ensuring vendors meet requirements given by customers through the Machine Specifications Documents as well as maintaining project sch...
The Advisory Senior Compliance Officer assists the Advisory Compliance Manager in communicating and implementing changes to the Compliance Policy, Program and Procedures as needed to improve compliance, or as required by amendments to the regulations. Senior Compliance Analyst - Advisory and Guidanc...
The role reports to the Manager, Trade Compliance in the Imports Department and will work closely with Import Operations, Corporate Social Responsibility, Global Sourcing, Product Compliance, Quality Assurance, Legal, Accounting, Security, and Transportation to ensure compliance to all applicable ru...
Project Development Manager to spearhead projects on the western half of the U. Project Development Manager will focus on a range of areas, from design & engineering to due diligence to interconnection. Manage project development through to construction start. Develop & track project budgets & sched...
Regulatory Affairs Specialist II. Regulatory Affairs Specialist II:. Regulatory Affairs Specialist II:. Works in close collaboration with internal customers and supports multiple projects to align on regulatory strategy to achieve business objectives. ...
Title: Project Manager Science Education & Community. The Manager Science Education & Community drives processes for optimal stakeholder engagement with a philanthropic foundation s science education and local STEM community grant portfolio. The position reports to the Senior Manager and Science...
This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Assist Regional Regulatory Represen...
Applies basic knowledge of compliance, business, analytical, and communication skills to support compliance programs and processes that promote compliant and ethical behavior, meet regulatory obligations, and prevent, detect, and mitigate compliance risks. This position will focus on compliance with...
Splunk is looking for a motivated Senior Analyst who is passionate about delivering technology assurance, advisory, compliance and risk management services to the company. You will ensure proper identification and mitigation of risks / processes / internal control gaps that have potential operationa...
This project involves planning and executing projects within a hybrid waterfall and agile environment. We have a direct relationship with the hiring manager on this critical project and are setting up interviews next week for someone who can hit the ground running. Media & Entertainment client to de...
The Compliance Analyst is responsible for auditing internal compliance reports and client documentation to determine the loan’s eligibility for purchase on the secondary market by ensuring compliance with applicable regulatory requirements including company and investor overlays. Compliance and/or Q...
Vice President or Senior Vice President, Regulatory Affairs & Quality Assurance. Lead Regulatory Affairs and Quality Assurance functions. Meet has engaged on a search for a confidential search for a VP/SVP of Regulatory and Quality with one of our biotech clients. Manage all aspects of Regulatory su...
Workers' Compensation Audit & Compliance Specialist. This position exists to ensure that claims are handled in compliance with the best practices and procedures compliant with applicable state laws. Designs and recommends compliance policies, processes and procedures for multi-jurisdictions states a...