US Regulatory Lead, Rare Disease — Regulatory Affairs Manager
Amgen Inc.
Amgen Inc. is seeking a Regulatory Affairs Manager - US Regulatory Lead for Rare Disease to guide regulatory strategy and compliance across the U.S. You will lead interactions with federal, state, and local regulators and manage local submissions for one or more Amgen products. The role includes preparing regulatory documents, supporting global plans, and contributing to labeling and regulatory strategy. A strong background in regulatory affairs and IND development is essential. #J-18808-Ljbffr Amgen Inc.
$112.74k - $152.54k
Regulatory Affairs Manager - US Regulatory Lead, Rare Disease What you will do Let’s do this. Let’s change the world. The Regulatory Affairs Manager at Amgen ensures the company’s compliance with all regulations and laws pertaining to the company’s business. They work with...SuggestedLocal areaFlexible hours$195.88k - $265.02k
...fight against the world’s toughest diseases. With our focus on four... ...Inflammation, General Medicine, and Rare Disease– we reach millions of... ...as part of the Amgen team. Join us and transform the lives of patients... ..., Disease Area Strategy Lead What you will do Let’s do...SuggestedFlexible hours$112.74k - $152.54k
Career Category Regulatory Job Description Join... ...world’s toughest diseases. With our focus on... ...General Medicine, and Rare Disease- we reach... ...Amgen team. Join us and transform the... ...career. Regulatory Affairs Manager - CMC What you... ...one of the world’s leading independent biotechnology...SuggestedFlexible hours- ...the world’s toughest diseases. Amgen is advancing a... ...obesity-related conditions, rare diseases, inflammatory... ...the Amgen team. Join us and transform the... ...responsibility of the FD is the management, performance, and... ...within US Medical Affairs, the FD leads their team to advance...SuggestedFlexible hours
$223.53k - $302.42k
...the world’s toughest diseases. Amgen is advancing a... ...obesity-related conditions, rare diseases, inflammatory... ...the Amgen team. Join us and transform the... ...responsibility of the FD is the management, performance, and... ...within US Medical Affairs, the FD leads their team to advance...SuggestedFull timeFlexible hours$195.64k - $264.69k
...Career Category Regulatory Job Description... ...world’s toughest diseases. With our focus on... ...General Medicine, and Rare Disease– we reach... ...Amgen team. Join us and transform the... ...Global Regulatory Affairs – Cardiometabolic... ...decision-making, and leading global interactions...Flexible hours$145.31k - $196.6k
...against the world’s toughest diseases. With our focus on four... ...General Medicine, and Rare Disease- we reach... ...of the Amgen team. Join us and transform the lives... ...career.Specialty Account Manager - Rare DiseaseLiveWhat... ...corporate legal and regulatory guidelines.Addresses issues...Full timeWork at officeRemote workFlexible hoursNight shift$141.52k - $191.47k
...world’s toughest diseases. With our focus... ...Medicine, and Rare Disease– we... ...Amgen team. Join us and transform the... ...The Senior Manager, Scientific Communications... ...across Medical Affairs, Clinical... ...and Oversight Lead development and... ...with regulatory and legal frameworks...Flexible hours$325.3k
...world’s toughest diseases. With our focus... ...Medicine, and Rare Disease- we... ...Amgen team. Join us and transform the... ..., U.S. Medical Affairs Cardiovascular... ...vital role you lead the U.S. Medical... ..., Access, Regulatory, Legal, and Compliance... ...disease, lipid management, and related...Full timeFlexible hours$133.08k - $180.05k
...world’s toughest diseases. With our focus... ...Medicine, and Rare Disease - we... ...Amgen team. Join us and transform the... ...Senior Manager LIVEWhat you will... ...organization. You will lead key elements of... ...global regulatory authorities. As... ...management, regulatory affairs, audit, law, or...Full timeWork at officeWorldwideFlexible hours$138.64k - $187.57k
...world’s toughest diseases. Amgen is advancing... ...related conditions, rare diseases,... ...Amgen team. Join us and transform the... ...Quality Control, Regulatory, Process Development... ...develop, implement, and manage strategies to meet... ...one of the world's leading independent biotechnology...Flexible hours$139.58k - $188.85k
...Regulatory Writing Senior Manager Live What you will do Let’s do... ...limited supervision, lead regulatory writing activities... ...in Regulatory Affairs, Research, Development... ...What you can expect of us As we work to... ...the complexities of disease and understand the fundamentals...Contract workFreelanceRemote workFlexible hours$149.35k - $202.06k
...& DMAB Patient Experience Lead, Marketing Senior Manager Bone Patient Experience & Access... ...in partnership with Legal, Regulatory, and Compliance teams.... ...What you can expect of us As we work to develop treatments... ...the fight against serious disease. Amgen is an Equal...Flexible hours- ...Health, Safety and Sustainability (EHSS) Manager in Thousand Oaks, CA. The role partners with... ...to drive safety initiatives, ensure regulatory compliance, and advance continuous improvement... ...performance. The ideal candidate will lead risk assessments, implement CAPAs, support...
$180k - $230k
...Position: Director, Global Regulatory Affairs Department:... ...The Global Regulatory Lead serves as the primary... ...and lifecycle management. The Director, Global... ...and frameworks in the US, EU, and Japan. •... ...• Experience in rare disease, orphan drug development...For contractorsRemote workWork from homeOverseas$141.52k - $191.47k
...the world’s toughest diseases. With our focus on... ...Medicine, and Rare Disease– we reach millions... ...Amgen team. Join us and transform the... ...career. The Senior Manager, Scientific Communications... ...Global Publication Lead, is accountable for... ...across Medical Affairs, and Clinical...Flexible hours$131.55k - $177.98k
...world’s toughest diseases. With our focus on... ...Medicine, and Rare Disease– we reach... ...Amgen team. Join us and transform the... ...career. Senior Manager, Corporate Affairs, Influencer Strategy... ...help build and lead an enterprise approach... ..., Advocacy, Law, Regulatory, Compliance and...Flexible hours$141.74k - $191.76k
...the world’s toughest diseases. With our focus on... ...Medicine, and Rare Disease– we reach millions... ...Amgen team. Join us and transform the... ...Forecasting Senior Manager, Cardiovascular... ...discussions with brand leads. The individual in... ...competitor launches, regulatory changes) on product...Contract workWork at officeFlexible hours- Dole Packaged Foods is seeking a senior Regulatory Compliance professional in the Americas to independently guide labeling, ingredients, nutrition and claims across US and Canada. You will own regulatory projects, partner with R&D, Marketing, Legal and Supply Chain to embed...Work at office
$132.04k - $178.64k
...the world’s toughest diseases. Amgen is advancing... ...conditions, rare diseases, inflammatory... ...the Amgen team. Join us and transform the lives... ...Assurance Senior Manager What you will do... ...Act as the quality lead for supplier... ...compliance with global regulatory standards, including...Remote workFlexible hours- ...the Senior Vice President of Regulatory, the Senior Director of Regulatory Affairs will support regulatory strategy and lead regulatory execution for... ...including leading submissions, managing regulatory vendors, support... ...meetings and equivalent ex-US interactions. Cross-...
- ...Introduction We are seeking a Director of Regulatory Compliance and Accreditation with Los... ...skills and come make a difference with us! Benefits Los Robles Regional... ...OR Certification in Healthcare Quality Management (CHCQM) required within 12 months Los...Full timeTemporary workPart timeFlexible hours
- ...DescriptionMake a global impact. Lead Teledyne’s enterprise-wide... ...Chief Trade Compliance Counsel, manage a Corporate Compliance... ...laws, regulations, rules and regulatory orders. Our reputation for honesty... ...high ethics is as important to us as our reputation for making innovative...Minimum wagePermanent employmentFull timeWork experience placementLocal areaWorldwide
- A leading staffing agency is looking for a Study Lead Statistician... ...teams for results that meet regulatory standards. The ideal candidate... ...conducting statistical analysis, managing timelines, and supporting... ...regulatory submissions. #J-18808-Ljbffr Randstad Life Sciences USRemote job
$110.03k - $148.87k
...the world’s toughest diseases. With our focus on... ...Medicine, and Rare Disease- we reach millions... ...Amgen team. Join us and transform the... ...your career. Project Manager, Congress Planning... ...The Project Manager leads planning and... ...marketing, medical, regulatory, legal, operations,...Remote workFlexible hours$208.32k - $281.84k
..., Value Strategy & Marketing - Rare Disease & Oncology Key responsibilities also include: Lead portfolio value strategy across... ...distribution, and utilization-management dynamics. Partner with Market... ...For more information, visit and follow us on #J-18808-Ljbffr...$168.04k - $227.35k
...Job Description Senior Manager, Value Strategy & Marketing... ...& Marketing will lead development and execution... ...training guides, burden-of-disease resources, and customer-... ...infused, biologic, specialty, rare-disease, and/or oncology... ..., visit and follow us on #J-18808-Ljbffr...$137.34k - $185.81k
...against the world’s toughest diseases. Amgen is advancing a... ...-related conditions, rare diseases, inflammatory... ...the Amgen team. Join us and transform the lives... ...and Operations Senior Manager What you will do... ...be one of the world's leading independent biotechnology...WorldwideFlexible hours$95 - $113.05 per hour
Overview The Study Lead Statistician (SLS) for product-facing work... ...sound, compliant with regulatory standards, and aligned with internal... ...alongside the Study Statistician, who manages operational statistical... ...Pharmaceutical Manufacturing #J-18808-Ljbffr Randstad Life Sciences USRemote jobHourly payContract workTemporary workWork experience placementLocal area- ...against the world’s toughest diseases. With our focus on four... ...General Medicine, and Rare Disease– we reach... ...of the Amgen team. Join us and transform the lives... ...engagement, annual reports, and regulatory filings including:... ...with and use of board management and online D&O...Work at officeFlexible hours
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