Job#: 2067675 Job Description: Sr. Manager, Regulatory Operations 2067675 Location: Waltham, MA (Hybrid) Focus: Small Molecule Job Overview: The Senior Manager for Regulatory Operations will handle regulatory submissions, liaise with global authorities, and strategize RNA-focused clinical development. Primary Job Responsibilities: Manage regulatory submissions, ensuring accurate preparation and publishing to global agencies.Assist in drafting and quality-checking regulatory materials and tem

About the team: As part of the Risk Data Transformation team of the Enterprise Data Office, you will be part of a team responsible to: Establish, maintain, and communicate the Risk Data transformation strategyDrive the remediation and adoption of consistent data management standards and capabilities to support the Enterprise Risk Management Framework across the enterprise and relevant businesses / functions / regions. About the role: The Citi Data Governance Policy (CDGP) provides a framework

PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries. 2. Prep

Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Our core activities are safeguarding assets, lending money, making payments and accessing the capital markets on behalf of our clients. Citi's Mission and Value Proposition explain what we do and Strategy explain how we do it. Our mission is to serve as a trusted partner to our clients by responsibly providing financial services that enable growth and ec

Title : Regulatory affairs - CMC Manager Location: Remote This will be 100% remote in the US only PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with 5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred. Responsibilities will include, but are not limited to, the following: 1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product su

Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Our core activities are safeguarding assets, lending money, making payments and accessing the capital markets on behalf of our clients. Citi's Mission and Value Proposition explain what we do and Strategy explain how we do it. Our mission is to serve as a trusted partner to our clients by responsibly providing financial services that enable growth and ec

Architect and design IT solutions tailored to global Regulatory Affairs functions, including submissions, registration tracking, labeling, and IDMP compliance. Develop and guide implementation of GenAI solutions (e.g., document summarization, narrative generation, intelligent labeling) for regulatory use cases. Lead end-to-end architectural governance for regulatory systems, including integrations with RIM, DMS, and Health Authority gateways. Design and optimize Cloud-native data pipelines for r

Piper Companies is Senior Manager for Regulatory Affairs Labeling Strategy to join the team a global biopharmaceutical company focused in neurology and immunology. In this role, you will lead labeling strategies, ensuring compliance with regulatory requirements while supporting product development and commercialization. This preferred candidate will be located in the Atlanta, GA or Raleigh, NC regions, however candidates outside of these regions will be considered as well. Responsibilities of

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut

Job DescriptionWho we are With its A.I.-powered robotic technology platform, Symbotic is changing the way consumer goods move through the supply chain. Intelligent software orchestrates advanced robots in a high-density, end-to-end system reinventing warehouse automation for increased efficiency, speed and flexibility. What we need We are seeking a highly experienced Director of Functional Safety Compliance and Regulatory Assurance to champion and enforce stringent safety standards for our cut