Regulatory Operations Specialist

Job SummaryBeacon Hill Life Sciences - Boston is seeking a highly skilled Regulatory Operations Contractor to support the development and implementation of systems and procedures used to support regulatory submission activities.This role will involve assisting with the production of electronic regulatory submissions, coordinating with cross-functional teams,...

Job DescriptionThe Head of Regulatory Operations at Takeda will be responsible for formulating and implementing the Global Regulatory Affairs Operations (GRA-Ops) vision and strategy to achieve a best-in-class Regulatory Operations organization. The role will involve envisioning and implementing a digital innovation ecosystem across GRA, R&D, and the...

Job DescriptionThe Senior Specialist, Regulatory Affairs plays a pivotal role in supporting the regulatory submissions process by developing strategic plans and submitting materials to health authorities such as the FDA for approval of novel platforms.This position provides critical regulatory guidance to internal development teams and prepares comprehensive...

Job Title: Paralegal Specialist for Regulatory AffairsJob Summary:We are seeking a skilled Paralegal Specialist to join our team at Dexian DISYS. As a Paralegal Specialist for Regulatory Affairs, you will be responsible for providing administrative support to our regulatory team.Key Responsibilities:Complete data entry onto excel spreadsheets, sort data, and...

About the RoleThe Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process by developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms. This position provides regulatory guidance to internal development teams and prepares document...

Job SummaryThe Senior Specialist, Regulatory Affairs will play a key role in supporting the regulatory submissions process through the development of regulatory strategy and submission of materials to health authorities such as the FDA for approval of novel platforms. This position will provide regulatory guidance to internal development teams and prepare...

About Northern Trust:Northern Trust is a globally recognized financial institution with a rich history dating back to 1889. We provide innovative financial services and guidance to the world's most successful individuals, families, and institutions by upholding our core values of service, expertise, and integrity.With over 130 years of financial experience...

Job Title: Senior Associate Regulatory Reporting Product SpecialistJob Summary:As a Senior Associate within the Regulatory Reporting Product team at Fidelity Investments, you will be responsible for building and maintaining the suite of applications that support required trade and customer account reporting for the firm and meet the strict requirements of...

Senior Director, Regulatory Affairs **Job Summary:** Proclinical is seeking a dynamic and strategic leader for the role of Senior Director of Regulatory Affairs. This position is pivotal in driving regulatory efforts for vaccine development programs. **Primary Responsibilities:** * Manage the full lifecycle of global regulatory submissions and approvals,...

Job OverviewWhite Collar Technologies Inc. is seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our life science consulting team, you will be responsible for ensuring compliance with regulatory requirements and providing expert guidance to clients.Key Responsibilities:Develop and implement regulatory strategies to...

Job Title: Audit/Compliance AnalystJob Summary:We are seeking a highly skilled Audit/Compliance Analyst to join our team at Saxon Global. The successful candidate will be responsible for ensuring compliance with regulatory requirements and identifying areas for improvement.Key Responsibilities:Conduct audits and investigations to ensure compliance with...

The Senior Clinical Laboratory Specialist at Massachusetts General Hospital plays a crucial role in ensuring the quality, safety, and efficiency of the blood bank operations. Reporting to the Senior Clinical Manager, this individual works closely with the BTS Medical Director, Laboratory Supervisors, Compliance Officer, Transfusion Safety Officer, and the...

Job Summary:Fairway Consulting Group is seeking a highly experienced Regulatory Affairs Director to lead our client's global regulatory strategy and execution on development programs. The ideal candidate will have a comprehensive knowledge of the drug development process, global regulations and guidelines, and a comprehensive understanding of global...

About the Role:Takeda Pharmaceutical is seeking a highly skilled Regulatory Affairs Manager to support the execution of regulatory CMC investigational, registration, and post-approval tasks for assigned products. As a key member of the Regulatory Affairs CMC team, you will work closely with cross-functional teams to develop project plans for global...

Regulatory Affairs ConsultantCapgemini is seeking a highly skilled Regulatory Affairs Consultant to manage and optimize our regulatory information management processes using the Veeva Vault RIM platform. The ideal candidate will have a strong background in regulatory affairs, experience with Veeva solutions, and a deep understanding of compliance...

Job SummaryGroundwork Operations, LLC is seeking a skilled Event Production Specialist to join our gig-based crew. As a key member of our team, you will be responsible for setting up and breaking down event spaces, including truss, pipe, and drape, signage, and hardware structures. Your attention to detail and ability to work efficiently in a fast-paced...

Job Description:Director, FDAS Compliance - Regulatory Relationship and Exam ManagementThe RoleAs a member of the Fidelity Digital Asset Services, LLC ('FDAS') Compliance team, you will serve as an informed and trusted business partner, who promotes a culture of ethical conduct and commitment to compliance, regulatory and legal obligations. In this role on...

Regulatory Affairs Senior Manager**Job Summary:**Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team. This role will focus on oncology, immunology, and related therapeutic areas.**Key Responsibilities:*** Develop and implement regulatory strategies to support the global development and approval of...

Job DescriptionAt CrossCountry Consulting, we are seeking a highly skilled Director, Regulatory Risk-Financial Services to join our team. As a key member of our leadership team, you will play a pivotal role in creating, developing, and building our presence in the Boston market.Key ResponsibilitiesLead a team of consultants responsible for developing,...

We're seeking a Quality Assurance Specialist to facilitate the authoring of effective Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs) in a pharmaceutical and medical products industry setting.Key responsibilities include managing the change request, deviation, and periodic review processes of procedural documents. Additionally, the...