Global Regulatory Lead, Rare Disease NDA/MAA Submissions
Taylor Strategy Partners
A late clinical-stage rare disease company is seeking a Director/Senior Director of Regulatory Affairs. In this strategic role, you will manage global regulatory strategies for submissions in the US, EU, UK, and Japan. You will lead major submissions, engage with regulatory agencies like the FDA and EMA, and ensure high-quality deliverables with external partners. Ideal candidates have over 10 years of experience in regulatory affairs, particularly in rare diseases, and possess a strong educational background in biology or chemistry. #J-18808-Ljbffr
- ...Gan & Lee Pharmaceuticals is seeking a Regulatory Affairs professional to support the implementation... ...ensuring compliance for product submissions and regulatory interactions. The ideal... ...with experience in metabolic diseases and strong communication skills are preferred...Regulatory
- ...against the world’s toughest diseases. With our focus on four... ...Inflammation, General Medicine, and Rare Disease- we reach millions... ...your career. Director, Global Regulatory Lead - Obesity & Related... ...of major global regulatory submissions, including clinical trial applications...RegulatoryFlexible hours
$122.25k - $176.58k
## Global Submission LeadBewerbenlocations: Morristown, NJ: Cambridge, MAtime type: Vollzeitposted... ...855370**Job title:** Global Submission Lead* **Location:** Morristown, NJ /... ...planning, coordination, and tracking of regulatory Priority portfolio and Integration submission...RegulatoryWorldwideFlexible hours- ...Apr is seeking a Contract Senior Manager, Regulatory Affairs, to oversee the submission of regulatory documents to National Health Authorities. This role requires a minimum of 5 years of regulatory affairs experience in the pharmaceutical or biotechnology sector. The successful...RegulatoryContract work
- ...Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international agencies. The role requires at least 7 years of experience in the pharmaceutical or biotech industry and strong management...RegulatoryRemote work
$176k - $236k
...Director, Global Regulatory Lead page is loaded## Director, Global Regulatory Leadlocations: Remote... ...goals.* Supports the preparation and submission of global regulatory documentation to... ...experience with INDs/CTAs, NDAs/BLAs/MAAs, lifecycle management, interactions with...RegulatoryHourly payTemporary workWork experience placementRemote workShift work- ...execution of clinical trials. The successful candidate will manage a clinical operations team, ensuring compliance with regulatory requirements while leading global trials. Candidates should have over 10 years of clinical operations experience, and a Bachelor's degree in a...RegulatoryWork at officeRemote work
$228k - $233k
...therapies for cancer and rare diseases. The company’s portfolio includes its lead candidate, TARA‑002,... ...The Director, Global Regulatory Affairs will lead Protara... ...leadership on regulatory submissions (IND/CTA) outside the... ...Experience supporting BLA/MAA preparation or review....RegulatoryRemote work$228k - $233k
...people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002,... ...Overview The Director, Global Regulatory Affairs leads Protara’... ...possess ex-US global submissions experience and manage... ...Experience supporting BLA/MAA preparation or review....RegulatoryLocal areaRemote work$176.4k - $207.5k
Recursion is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies and oversee processes. This role requires at least 10 years of experience in the pharmaceutical industry, with 8 years in Global Regulatory Affairs. The ideal candidate...RegulatoryRemote work- ...Role Late clinical‑stage rare disease company preparing for NDA & global submissions and commercial... ...Director/Senior Director, Regulatory Affairs to join as their... ...Review system (sub-IRAS). Lead the preparation, authoring... ..., including NDA, MAA, and JNDA components. Support...Regulatory
$185.5k - $202k
...Kyowa Kirin is a fast-growing global specialty pharmaceutical... ...deliver novel medicines in four disease areas: bone and mineral; intractable... ...; hematology oncology; and rare disease. A Japan-based... ...exists Adhere strictly to all regulatory, compliance, and company...RegulatoryTemporary workSummer workWork at officeLocal areaShift workNight shift- A global biotechnology company is seeking a Director, Global Regulatory Lead for obesity and related conditions. This role entails leading regulatory strategies, overseeing global submissions, and engaging with health authorities. The ideal candidate has significant experience...Regulatory
- .... is seeking a Director of Global Regulatory Affairs in New York, NY. The... ...successful candidate will lead ex-US regulatory strategy and... ...across oncology and rare disease programs. Responsibilities... ...include preparing regulatory submissions, managing specific regulatory...RegulatoryRemote work
$122.25k - $176.58k
## Global Regulatory Affairs (GRA) Chemistry, Manufacturing and Controls (CMC) CMC LeadBewerbenlocations... ..., Manufacturing and Controls (CMC) CMC Lead**Location:** Morristown, NJ /... ...while preparing high-quality regulatory submissions, managing compliance, and anticipating...RegulatoryTemporary workWorldwideFlexible hours$170k - $190k
...Senior Manager, Global Regulatory Affairs Labeling This range is provided... ...plays a key role in leading end-to-end labeling activities... ...development-stage programs in the rare disease space. This role... ...to internal approval and/or submission of labeling to health authorities...RegulatoryFull timeWork experience placementLocal areaRemote work$120k - $140k
...Position Summary Praxis’s Regulatory team is seeking an astute Senior Regulatory Submissions Manager who will oversee... ...strategy and CMC leads, cross‑functional colleagues, and global vendors, from initiation... ...submissions (IND, IMPD, NDA, MAA, Agency Responses, others...RegulatoryWork at officeLocal areaRemote workFlexible hours- ...Thought Leader Liaison Rare Blood Disorders, Northeast... ...the Job** Sanofi, a global and diversified healthcare... ...innovative drugs, rare diseases, rare blood disorders,... ...compliance, legal and regulatory guidelines.KOL... ...appropriate communication* Lead planning, execution and...RegulatoryWork experience placementWork at officeLocal areaRemote workHome officeShift work
- A biopharmaceutical company is seeking a Senior Manager, Global Regulatory Affairs Labeling to lead its global labeling initiatives. This role involves strategy development for labeling, ensuring compliance, and managing cross-functional stakeholder reviews. Candidates...RegulatoryRemote work
- ...INIZIO is looking for a professional to lead HR compliance and policy frameworks globally across the organization. You will ensure alignment with employment legislation and regulatory requirements while supporting HRLT priorities and compliance strategy. Successful candidates...Regulatory
- ...A leading technology company is seeking a Payments & Compliance Manager to oversee its global payments ecosystem. This person will manage relationships with various partners... ...contract terms, and ensure compliance with regulatory requirements. Ideal candidates will have...RegulatoryContract work
$78.9k - $131.5k
...Rippling is seeking a Payments Licensing Specialist to assist with global payments and lending licensing. This role involves managing licensing processes, regulatory examinations, and improving compliance. Ideal candidates have 3+ years in regulatory roles, possess strong...Regulatory- ...professional to act as a bridge between the Chinese market and global compliance functions. The role requires a minimum of 3 years' experience in compliance or legal settings, familiarity with regulatory environments, and proficiency in both Chinese and English. The position...Regulatory
- ...Framework Ventures is seeking a Global Regulatory Legal Head to lead their regulatory affairs globally. The ideal candidate will be responsible for overseeing compliance across jurisdictions and managing the global regulatory legal team. With 12-15 years of experience...RegulatoryRemote work
$259k - $394k
...biotechnology company is seeking a Vice President of Regulatory Affairs to develop and execute regulatory strategies for global pipeline programs. The ideal candidate will... ...be responsible for managing regulatory submissions, leading health authority interactions, and...Regulatory$206k - $268k
...USA- Remote Be a part of a global team that is inspired to... ...lives of people living with rare disease. At Travere Therapeutics... ...pursue our vision of becoming a leading biopharmaceutical company... ...in preparation for potential regulatory approval and launch. The...RegulatoryTemporary workRemote work$160k - $220k
...Full time Remote: Yes Job Description: We are seeking a Global Energy Research & Analysis Lead - North America, to drive the monitoring and analysis... ...to market and technology trends, longer-term policy and regulatory developments, institutional advocacy inputs shaping the...RegulatoryFull timeRemote workShift work$160k - $180k
...A leading biopharmaceutical company is seeking a Senior Manager/Associate Director of Regulatory Strategy. This role involves supporting global regulatory initiatives for clinical development programs and managing IND lifecycle activities. The ideal candidate will have...RegulatoryRemote work- ...candidate will have a bachelor's degree and 3+ years of sales experience in the pharmaceutical industry, preferably with a focus on rare diseases. Extensive travel is expected, amounting to about 50% of work time, along with a comprehensive benefits package. #J-18808-Ljbffr...
$255k - $270k
Anthropic is seeking a Content Moderation Specialist in Seattle, WA to manage global content moderation and compliance programs. The ideal candidate will have over 5 years of experience in regulatory compliance in tech, excellent communication skills, and the ability to...Regulatory
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