- Citigroup (Tampa, FL)
- …the ability to work across the various risk segments. **Team Overview:** The Risk Regulatory Affairs team ensures the Independent Risk organization ... Risk Management perspective; + Produce thematic summaries to Senior Management on regulatory interactions and developments...strategy for regulatory engagement activities across the Risk Regulatory Affairs team to… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …researching on real-world evidence, and creating hope for all facing illness. The Senior Director, Commercial Regulatory Affairs , is responsible for the ... marketed products in US and Canada. In addition, the Senior Director, Commercial Regulatory Affairs ,... management to mitigate or avert risks. + Ensures regulatory commitments (eg, DHCP letters, labeling changes, risk… more
- Medtronic (Boston, MA)
- SENIOR REGULATORY AFFAIRS SPECIALIST - Digital Technologies The Senior Regulatory Affairs Specialist will play a key role in launching new ... US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide. Sustaining… more
- ADM (Kennesaw, GA)
- **83651BR** **Job Title:** Senior Regulatory Affairs Manager - Kennesaw, GA **Department/Function:** Legal, Compliance, Regulatory Affairs , Corporate ... Security **Job Description:** ** Senior Regulatory Affairs ** **Manager - Kennesaw, GA** This is a full-time,...S&T, RSA, Legal, Marketing and Commercial. + Own the Regulatory Risk Assessments related to the permissibility… more
- Integra LifeSciences (GA)
- …and making headway to help improve outcomes. The Sr. Regulatory Affairs Specialist is a seasoned senior professional role responsible for contributing ... in the US, EU, Canada and globally. The Sr. Regulatory Affairs Specialist is responsible for providing...product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971. + Work… more
- Teva Pharmaceuticals (West Chester, PA)
- Senior Director, Regulatory Affairs CMC , Innovative Medicine (Hybrid) Date: Mar 28, 2024 Location: West Chester, United States, Pennsylvania, 19380 Company: ... making a difference, and new people to make a difference with. **The opportunity** The Senior Director, Regulatory Affairs CMC is responsible to manage and… more
- ConvaTec (Lexington, MA)
- …about Convatec, please visit http://www.convatecgroup.com **Job Summary:** In this role as a Senior Regulatory Affairs Specialist at Convatec, you will be ... division's global regulatory strategies and processes. The Senior Regulatory Affairs Specialist will...business partners and junior regulatory staff regarding regulatory requirements including indications of risk and… more
- Lilly (Indianapolis, IN)
- …people who are determined to make life better for people around the world. ** Senior Advisor/Director, Global Regulatory Affairs - CMC, Small Molecules** At ... patients who need them all over the world. The Senior Advisor/Director in Global Regulatory Affairs...Authority meetings. + Demonstrated ability to assess and manage risk in a highly regulated environment. + Demonstrated strong… more
- Kelly Services (Cuyahoga Falls, OH)
- Kelly Science & Clinical is seeking a ** Senior Regulatory Affairs Specialist near Cuyahoga Falls, OH.** **Direct Hire** **Shift:** Monday - Friday 8am-5pm ... engineering or other technology field + 5+ years of progressive experience in regulatory affairs required + Appropriate combination of education and experience… more
- Abbott (Plymouth, MN)
- …get on with their lives. **The Opportunity** Abbott is seeking a passionate, experienced ** Senior Regulatory Affairs Specialist** to join our team on-site in ... Paul, MN. In this role, you will lead the preparation and submission for regulatory approvals and identify and resolve problems. You will provide regulatory … more
- Bausch Health (Bothell, WA)
- …care options to consumers and physicians alike. Reporting to the Sr. Director, Global Regulatory Affairs , the Senior Manager, Regulatory Affairs ... in maintaining regulatory compliance. * Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory… more
- Zimmer Biomet (Warsaw, IN)
- …for impact on regulatory status of the product. + Follow Zimmer Biomet regulatory affairs policy and procedures. + May provide training and/or guidance to ... and governmental agencies. **Your Background** Requires a Bachelor's degree in Regulatory Affairs , Engineering, or Life Sciences, or related field. Requires… more
- Lilly (Indianapolis, IN)
- …tactical, and operational support for market registrations and post-approval submissions. The regulatory scientist in Global Regulatory Affairs - CMC ... of molecule specific CMC development strategies and submission content + Makes risk -based decisions on CMC regulatory strategies impacting product submissions… more
- BeiGene (Emeryville, CA)
- …and communicates CMC regulatory strategies for the assigned projects. . Lead regulatory risk assessment, identify key CMC regulatory issues and ... **General** **Description:** BeiGene is seeking an experienced and energetic regulatory professional to manage, evaluate, and complete regulatory projects… more
- Amgen (Thousand Oaks, CA)
- …and leading the global policy and regulatory intelligence teams. Reporting to the Senior Vice President, Global Regulatory Affairs , this key senior ... science that can turn the tide of serious, life-interrupting illnesses. **Head of Regulatory Affairs Policy & Intelligence** **Live** **What you will do** Let's… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …for the clinical research aspects of registration activities with a working knowledge of regulatory affairs , in the development of the project strategy and the ... Job Title Senior Director, Clinical Development & Medical Affairs...Affairs , Strategic Operations, Evidence Generation & Data Sciences, Regulatory Affairs , Pharmacovigilance) Strategy/Portfolio Management, Global Device… more
- MicroVention, Inc. (Aliso Viejo, CA)
- **12152BR** **Title:** Intern, Regulatory Affairs **Job Description:** Are you interested in working for an organization that is making a difference in people's ... closer look at what MicroVention(R) TERUMO has to offer. Regulatory Affairs (RA) Intern The Regulatory...regulatory submissions + Shadow and/or partner with a senior regulatory professional(s) to learn and interpret… more
- Ascendis Pharma (Palo Alto, CA)
- …activities and those of direct reports. + Work is performed under direction of a Senior Regulatory Affairs professional. Requirements + BS/BA Degree in a ... in Palo Alto, CA and reports directly to the Senior Director, Regulatory Affairs . Key...+ Contributes to the development of global clinical and regulatory plans and strategies, identifies, and proposes risk… more
- Huntington Ingalls Industries (Washington, DC)
- …we are HII Mission Technologies, in Washington, DC, is seeking a Congressional Affairs Analyst to support the Defense Innovation Unit (DIU). The Congressional ... Affairs Analyst is responsible for assessing the efficiency, effectiveness,...include analyzing the impact of current and proposed policy, regulatory , and statutes; developing potential courses of action to… more
- Philips (San Diego, CA)
- …Implements internal or external quality system audits. + Reporting to the Director of Regulatory Affairs , the Senior RA Specialist will collaborate with ... + The Senior RA Specialist provides the regulatory plan, guidance on risk assessment, and...for earliest possible approvals of clinical trials applications. + Regulatory Affairs representative for the CT/AMI Systems… more