Global Regulatory Development Lead
3 weeks ago
We are seeking a highly motivated and experienced Senior Manager of Regulatory Affairs to join our team at Sail Biomedicines. This role will be responsible for developing and executing our regulatory operations and planning, managing, and tracking regulatory submissions.
Responsibilities:- Develop regional regulatory operations that de-risk and accelerate the registration of innovative and established medicines for both US and OUS regulatory agencies.
- Execute global registration strategies that enhance the likelihood of regulatory approval through the pursuit of novel regulatory pathways and continuous sponsor/regulatory dialog in support of EU and US business priorities.
- Manage global regulatory development plans for all projects within scope, ensuring clinical trial requirements for global product approval are met.
- Develop and maintain a submission content plan, tracking documents from authoring to approval, publishing, and QC.
- Effectively communicate project status, issues, schedule, and accomplishments to various management and stakeholder groups.
- BS with 8+ years of industry experience (or equivalent combination of education and experience) with at least 5+ years in regulatory affairs.
- Submission experience with Nanoparticle based therapeutics, RNA, or Gene Therapy.
- Expert knowledge of relevant FDA, EU, and ICH guidelines and regulations.
- Experience as a primary regulatory author for IND, BLA, and CTA documents.
- Strong experience with CTD format and content regulatory filings.
$160,000 - $240,000 per year
Sail Biomedicines offers a comprehensive compensation package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
-
Global Regulatory Lead
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Indo Search Full timeJob Title: Regulatory Affairs DirectorLocation: Cambridge, UKSalary Range: £150-£200,000 per annumAbout the Role:We are seeking a highly experienced Regulatory Affairs professional to lead our compliance and strategy efforts in the medical device industry.The successful candidate will be responsible for implementing regulatory strategies that align with...
-
Global Regulatory Affairs Lead
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeAssociate Director, Global TA Regulatory LiaisonsGilead Sciences, Inc. is a leading biotechnology company that discovers, develops, and commercializes innovative therapeutics to treat life-threatening diseases.Salary: $180,000 - $220,000 per yearJob Description:Act as the Regional Regulatory Lead on complex or multiple products, compounds, indications, or...
-
Global Regulatory Development Manager
3 days ago
Cambridge, Cambridgeshire, United Kingdom Tbwa ChiatDay Inc Full timeJob Description:The Senior Regulatory Operations Specialist will lead the development and execution of Sail's regulatory operations and planning, managing, and tracking regulatory submissions. This role will be responsible for developing regional regulatory operations that de-risk and accelerate the registration of innovative and established medicines for US...
-
Global Regulatory Lead
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Indo Search Full timeAs a member of our team, you will have the opportunity to work on groundbreaking medical technologies and make a lasting impact. We are seeking a talented Global Regulatory Lead to drive regulatory excellence and compliance for complex Class IIb/III devices.The ideal candidate will have substantial experience in regulatory affairs within MedTech, combining...
-
Global Therapeutic Area Regulatory Lead
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Full timeAbout GileadGilead Sciences, Inc. is a global biopharmaceutical company dedicated to developing innovative treatments for life-threatening diseases. We're looking for talented individuals to join our team as Global Therapeutic Area Regulatory Lead.Job DescriptionIn this role, you will act as the Regional Regulatory Lead on more complex or multiple products,...
-
Global Regulatory Lead
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Tbwa ChiatDay Inc Full timeSail Biomedicines is seeking an experienced Global Regulatory Lead to join its team. As a key member of the company's regulatory operations, you will be responsible for developing and executing global registration strategies that enhance the likelihood of regulatory approval.The ideal candidate will have 8+ years of industry experience in regulatory affairs,...
-
Global Regulatory Strategy Manager
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeMoonLake Immunotherapeutics is an exciting place to work, offering a unique opportunity to contribute to ground-breaking projects that have the potential to transform global healthcare. As a Global Regulatory Strategy Manager, you will play a key role in developing and implementing innovative regulatory strategies for sonelokimab lead indication(s).About the...
-
Global Regulatory Affairs Manager
1 week ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeJob DescriptionWe are seeking an experienced Global Regulatory Affairs Manager to join our team. This role will be responsible for leading the development and implementation of global regulatory strategies for multiple products or projects. The ideal candidate will have a strong background in regulatory affairs, excellent leadership skills, and the ability...
-
Global Regulatory Strategist
3 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeCompany OverviewAt MoonLake Immunotherapeutics, we are committed to creating novel therapies that elevate treatment horizons. As a key member of our team, you will have the opportunity to work on groundbreaking projects that have the potential to transform global healthcare.Job DescriptionWork closely with functional colleagues and project teams to develop...
-
Regulatory Affairs Lead
3 days ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob TitleWe are seeking a Regulatory Affairs Lead to join our team at MoonLake Immunotherapeutics. As a key member of our regulatory affairs department, you will play a vital role in developing and implementing innovative global regulatory strategies for sonelokimab lead indication(s).This position offers an excellent opportunity to contribute to the...
-
Senior Regulatory Lead
1 week ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeRegulatory Affairs LeaderThis Senior Regulatory Lead position requires a highly experienced professional to lead regulatory strategy and operations across multiple products or projects. The ideal candidate will have a deep understanding of regulatory requirements and procedures, excellent leadership skills, and the ability to drive cross-functional...
-
Global Regulatory Compliance Expert
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Bicycle Therapeutics Full timeSenior Regulatory Associate PositionA highly rewarding opportunity awaits at Bicycle Therapeutics! We seek an experienced Senior Associate, Regulatory Affairs to spearhead our global regulatory strategy for various programs and projects. Join our dynamic team and make a meaningful impact in the world of pharmaceutical innovation.Role Highlights* Lead the...
-
Senior Regulatory Lead
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Cpl Life Sciences Full timeRegulatory Affairs Leadership OpportunityWe are seeking an experienced Senior Director to lead our Regulatory Affairs team at Cpl Life Sciences.Key Responsibilities:Provide strategic regulatory advice to clients, taking into account regulatory guidelines and available measures to facilitate regulatory input.Develop and implement effective regulatory...
-
Regulatory Affairs Strategy Lead
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob SummaryWe are seeking a highly skilled Regulatory Affairs Strategy Lead to join our team at MoonLake Immunotherapeutics.This is an exceptional opportunity for a seasoned professional with expertise in regulatory affairs and a passion for innovative global strategies to drive drug development.
-
Cambridge, Cambridgeshire, United Kingdom MoonLake Immunotherapeutics Full timeJob DescriptionMoonLake Immunotherapeutics is seeking a skilled Regulatory Affairs Strategist to develop and deliver innovative global regulatory strategies for sonelokimab lead indication(s). This role will be an integral part of our team, responsible for regulatory aspects related to product development and approval.We are looking for a candidate with a...
-
Global Investigations Lead
1 month ago
Cambridge, Cambridgeshire, United Kingdom Mundipharma Full timeJob Description:We are seeking a highly skilled Global Investigations Lead to join our team at Mundipharma. This is a permanent position based in GB Cambridge.About the Role:The successful candidate will be responsible for implementing and overseeing the global compliance hotline and investigations program. They will ensure that investigations are thorough,...
-
Regulatory Affairs Lead for Complex Devices
3 days ago
Cambridge, Cambridgeshire, United Kingdom Indo Search Full timeHead of Medical Technology ComplianceAs a highly respected Head of Medical Technology Compliance, you will be responsible for leading our regulatory team and driving compliance for our groundbreaking medical technologies. You will develop and implement global regulatory strategies for advanced Class IIb/III medical devices and oversee post-market...
-
Regulatory Affairs Manager
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Gilead Sciences, Inc. Full timeAt Gilead Sciences, Inc., we're seeking a highly experienced Regulatory Affairs Manager to lead our Global Regulatory team in the development and implementation of regulatory strategies for our Therapeutic Area (TA) portfolio. This role will oversee the preparation and submission of regulatory documents, as well as ensure compliance with global...
-
Global Regulatory Coordinator
3 weeks ago
Cambridge, Cambridgeshire, United Kingdom Dr. Reddy's Laboratories Full timeRegulatory Affairs Job Opportunity in Dr. Reddy's LaboratoriesWe are looking for a talented EU Regulatory Affairs Specialist to join our team in Cambridge, UK. As a key member of our Regulatory Affairs team, you will be responsible for supporting the preparation and submission of regulatory documentation for marketing authorization applications in the...
-
Regulatory Affairs Director
2 weeks ago
Cambridge, Cambridgeshire, United Kingdom Indo Search Full timeIndo Search is a ground-breaking developer of high-end medical technologies with ambitious plans to scale globally.We are seeking an experienced Regulatory Affairs Director to lead our regulatory team in achieving global compliance for complex Class IIb/III devices.The ideal candidate will have extensive senior-level experience in medical device regulatory...