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
$178.5k - $257.83k
## Global Regulatory LeadBewerbenlocations: Morristown, NJ: Cambridge, MAtime... ...title:** Global Regulatory Lead**Location:** Morristown, NJ... ...Strategy (GRPS), Global Submission Strategy, and core product labeling... ...preparation of (s)BLA, (s)NDA, or MAA, INDs, Health Authority...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
- ...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
$140k - $160k
...Iovance Biotherapeutics is seeking a Manager, Regulatory Affairs CMC to oversee regulatory submissions and collaborate with cross-functional teams. The ideal candidate will have at least 8 years of experience in regulatory affairs and a BA/BS degree in a related field...Regulatory- ...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
- ...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
- ...Clinical Research Director - Rare Diseases**Location:** Cambridge... ...knowledge and lead clinical study development... ...strategy with the global project team and internal... ...medicine, regulatory affairs, biostatistics... ...development plans, and submission dossiers for regulatory...Regulatory
$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$228k - $233k
...Director, Global Regulatory Affairs New York, NY, Remote... ...people with cancer and rare diseases. Protara's portfolio includes its lead candidate, TARA-002, an... ...possess ex-US global submissions experience and manage... ...Experience supporting BLA/MAA preparation or review....RegulatoryLocal areaRemote workFlexible hours- ...Bristol Myers Squibb is seeking a Senior Manager, Submission Management Clinical Trials to oversee regulatory activities for clinical trial submissions. This role... ...preparing submissions for health authorities, and leading continuous improvement initiatives. The ideal...Regulatory
- ...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
- ...Sanofi is seeking a Global Regulatory Lead in Morristown, NJ. This role is responsible for leading the development and execution of innovative... ...at least 8 years in biopharma. Experience with regulatory submissions and interactions with health authorities is essential. A...Regulatory
- ...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
- Initial Therapeutics, Inc. is seeking a Director of Global Regulatory Affairs to drive ex-US regulatory strategies for clinical studies focused on oncology and rare diseases. The ideal candidate will lead IND and CTA submissions, leveraging extensive regulatory experience. A...RegulatoryRemote job
$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- ...Product Management – Oncology (Rare Disease) Jubilant DraxImage (USA) Inc... ...leader to build and lead the end-to-end go-to-market strategy... ...functionally with Medical Affairs, Regulatory, Market Access, and... ...opportunities for growth within a global organization committed to...RegulatoryRemote 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
- ...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
$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- ...seeking an experienced Clinical Pharmacy Manager for Infectious Diseases to oversee clinical pharmacy services. The role involves... ...collaboration with various healthcare providers, and maintaining regulatory compliance. The ideal candidate has a Doctor of Pharmacy, relevant...Regulatory
$194.04k - $228.25k
...Associate Director of Regulatory Affairs who will... ...in supporting global regulatory... ...cross-functional leads to support the development... ..., pediatric submissions, etc.). Create, collaborate... .... Oncology, rare disease and I&I is good... ...Applications (NDA/NDS/MAA), post marketing...RegulatoryOdd jobWork at officeLocal areaImmediate startRemote workWork from home$79.8k - $139.6k
...Patient Engagement Lead – Global Clinical Trial Recruitment and Retention Location: Remote, U.S. Salary Range: $79,800 – $139,600 Overview... ...Ensure all deliverables meet sponsor expectations, regulatory requirements, and internal quality standards Financial & Project...RegulatoryContract workImmediate startRemote 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...
$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- PayPal is seeking a Senior Manager for its Global Regulatory Relations team. The role involves providing leadership to cultivate strong regulatory relationships and overseeing complex projects to address challenges. Ideal candidates have 8+ years of experience, strong analytical...Regulatory
- ...A leading investment firm based in New York is seeking a Director of Global Compliance to oversee regulatory compliance for broker-dealer functions. The role involves leading a compliance team, providing strategic guidance, and ensuring adherence to regulatory requirements...Regulatory
- 1100 Mylan Pharmaceuticals Inc. is seeking a Manager for Global Quality Investigations. This role is pivotal in performing real-time review of investigations and ensuring compliance with regulatory standards. The ideal candidate has a Bachelor's degree and at least 4-7...RegulatoryWork at officeRemote work
- ...Associate Director, Obligations Management, to oversee the governance infrastructure for regulatory and financial requirements. This role involves leading the architecture of the Global Obligations Register and ensuring compliance across Airwallex's global footprint. The...Regulatory
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