Regulatory Affairs Director
7 days ago
In this pivotal role, you will lead the planning and coordination of CMC regulatory submissions for Vericel Corporation, a pioneering biotechnology company. Reporting directly to Regulatory Management, you will work independently with oversight and be responsible for timely completion of complex regulatory projects.
About the JobThis full-time position is based in Burlington, MA, with occasional travel (5-10%). You will oversee CMC regulatory activities, develop strategies for earliest possible approvals, manage preparation of organized and scientifically valid CMC and marketing registration applications, and represent the company in dealings with regulatory authorities.
Responsibilities- Oversee CMC Regulatory Activities: Recommend and implement CMC regulatory initiatives in agreement with senior management and company goals.
- Develop Strategies for Regulatory Approvals: Develop, recommend, and implement strategies for the earliest possible approvals of CMC regulatory submissions associated with assigned development projects.
- Manage Regulatory Submissions: Manage and facilitate preparation of organized and scientifically valid CMC and marketing registration applications, supplements, amendments, and variations.
- Ensure Regulatory Compliance: Ensure regulatory submissions are maintained in compliance with regulatory requirements in close partnership with internal stakeholders and external partners.
- Represent the Company: Represent the company in its dealings with the FDA and other regulatory authorities, as appropriate.
- Bachelor's Degree: Bachelor of Science in a scientific discipline; Master of Science preferred.
- Direct Experience: 10+ years with direct CMC Regulatory Affairs experience in the US market.
- Industry Knowledge: Practical and regulatory experience in cell therapy or biologics; previous experience with combination products and/or botanicals a plus.
- Leadership Skills: Demonstrated success in leading complex groups to support operational goals and contribute to the development of CMC regulatory initiatives.
- Regulatory Expertise: Working knowledge of FDA regulations and understanding of eCTD elements and structure.
- Salary: $120,000 - $150,000 per year, depending on experience.
- Location: Burlington, MA.
- Travel: Occasional travel (5-10%) may be required.
-
Regulatory Operations Director
6 days ago
Burlington, Massachusetts, United States Vericel Corporation Full timeVericel Corporation: Manager of Regulatory Job OpportunityOverview:Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, seeks a highly skilled Regulatory Operations Director to join their team. Located in Burlington, MA, this role offers a unique opportunity to work with a commercial stage company that has...
-
Senior Clinical Development Director
5 days ago
Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full timeTransforming Cardiovascular MedicineWe are seeking a seasoned Sr. Clinical Development Director to join our esteemed team at Cardurion Pharmaceuticals, Inc. As the ideal candidate, you will lead clinical development efforts for innovative cardiovascular therapies.About the RoleYou will be responsible for overseeing the entire lifecycle of clinical trials,...
-
Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full timeAbout the RoleWe are seeking an experienced Senior Clinical Development Director to join our Cardiovascular Sciences team. As a key member of our clinical development group, you will be responsible for leading the development and execution of clinical trial strategies for our cardiovascular programs.Key ResponsibilitiesLead cross-functional teams to develop...
-
Clinical Supply Chain Manager
6 days ago
Burlington, Massachusetts, United States Cardurion Pharmaceuticals, Inc Full timeWe are seeking a highly skilled Clinical Supply Chain Manager to join our team at Cardurion Pharmaceuticals, Inc. in the United States.Job Summary:The ideal candidate will have 5+ years of experience in clinical supply chain management and a strong understanding of regulatory requirements for clinical supply distribution in the US, EU, and APAC.Key...
-
Burlington, Massachusetts, United States BRIOHEALTH SOLUTIONS INC Full timeOverviewWe are a global team of Med-Tech professionals at BrioHealth Solutions Inc., dedicated to developing patient-centric solutions. Our focus is on creating advanced therapies for heart failure, leveraging our unique BrioVAD Left Ventricular Assist System (LVAS).About the RoleThe estimated salary range for this position in the United States is $140,000 -...
-
Burlington, Massachusetts, United States Glaukos Corporation Full timeAbout UsGlaukos Corporation is an ophthalmic pharmaceutical and medical technology company dedicated to developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.Our MissionWe aim to transform vision by pioneering dropless therapies that can meaningfully advance the standard of care and improve the...
-
Director, Regulatory Affairs
4 weeks ago
Burlington, United States Vericel® Corporation Full timeThis role will be based full time in our new, state of the art facility located in Burlington, MA. There may be times that a visit to our current Cambridge location will be necessary.Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Regulatory...
-
Director, Regulatory Affairs
4 weeks ago
burlington, United States Vericel® Corporation Full timeThis role will be based full time in our new, state of the art facility located in Burlington, MA. There may be times that a visit to our current Cambridge location will be necessary.Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Regulatory...
-
Director, Regulatory Affairs
4 weeks ago
Burlington, United States Vericel® Corporation Full timeThis role will be based full time in our new, state of the art facility located in Burlington, MA. There may be times that a visit to our current Cambridge location will be necessary.Vericel Corporation, a leader in advanced therapies for the sports medicine and severe burn care markets, has an exciting opportunity for a top performing Regulatory...
-
Utilities Director
5 days ago
Burlington, United States Sugarbush Resort Full timeUtilities Director at Sugarbush Resort summary: The Utilities Director at Sugarbush Resort is responsible for overseeing all aspects of the resort's utility operations, including compliance, safety, financial management, and customer relations. This position manages water and wastewater treatment systems, ensuring proper functioning and adherence to...
-
Burlington, Vermont, United States PharmaEssentia U.S.A. Full timeCompany OverviewPharmaEssentia USA Corporation is a rapidly growing biopharmaceutical innovator that leverages deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in hematology and oncology. With one product approved and a diversifying pipeline, the company aims to improve both health and quality of...
-
Utilities Director
3 weeks ago
burlington, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year RoundRESORT OVERVIEW:Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want to...
-
Utilities Director
3 weeks ago
Burlington, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year RoundRESORT OVERVIEW:Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want to...
-
Utilities Director
2 weeks ago
Burlington, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year RoundRESORT OVERVIEW:Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want to...
-
Utilities Director
2 weeks ago
Burlington, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year RoundRESORT OVERVIEW:Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want to...
-
Utilities Director
2 days ago
Burlington, United States Sugarbush Resort Full timeUtilities Director at Sugarbush Resort summary: The Utilities Director at Sugarbush Resort oversees all operational aspects of the utility services, ensuring compliance with safety regulations and effective management of resources. This role involves planning, supervising, and evaluating maintenance and construction of infrastructure while maintaining...
-
Director of Academic Emergency Medicine
6 days ago
Burlington, Vermont, United States The University of Vermont Full timeAbout the OpportunityWe are seeking a visionary leader to direct our Residency Program in Emergency Medicine at The University of Vermont. As Director, you will oversee a dynamic team of educators and clinicians, driving excellence in resident education and patient care.ResponsibilitiesLead a residency leadership team, including Assistant and Associate PDs...
-
Utilities Director
3 weeks ago
Burlington, VT, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year Round RESORT OVERVIEW: Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want...
-
Utilities Director
2 weeks ago
Burlington, VT, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year Round RESORT OVERVIEW: Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want...
-
Residence Director
1 month ago
Burlington, United States InsideHigherEd Full timeAdvertising/Posting Title:Residence DirectorDiversity Statement:The University is especially interested in candidates who can contribute to the diversity and excellence of the institution. Applicants are encouraged to include in their cover letter information about how they will further this goal.Posting Summary:The Residence Director (RD) is responsible for...
-
Residence Director
3 months ago
Burlington, United States InsideHigherEd Full timeAdvertising/Posting Title:Residence DirectorDiversity Statement:The University is especially interested in candidates who can contribute to the diversity and excellence of the institution. Applicants are required to include in their cover letter information about how they will further this goal.Posting Summary:The Residence Director (RD) is responsible for...
-
burlington, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year RoundRESORT OVERVIEW:Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want to...
-
Residence Director of Student Communities
7 days ago
Burlington, Vermont, United States The University of Vermont Full timeAbout The University of VermontThe University of Vermont is a world-class institution committed to creating and maintaining safe communities that welcome and accept people of all backgrounds.Job SummaryWe are seeking a highly motivated Residence Director of Student Communities to join our team. This is a live-in position with a two-year term, offering a...
-
Utilities Director
3 weeks ago
Burlington, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VT Year RoundRESORT OVERVIEW:Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an array of dining venues, and a fully appointed Health and Recreation Center. Do you want to...
-
Executive Director of Facilities Management
1 month ago
Burlington, United States InsideHigherEd Full timeAdvertising Copy:The Executive Director of Facilities Management is a critical leadership position that helps to ensure the success of the University by providing strategic leadership and management oversight for all aspects of facilities, transportation, utility infrastructure, capital construction, and preventative/deferred maintenance. This includes...
-
Utilities Director
1 month ago
Burlington, United States Sugarbush Resort Full timePlease note, this position is located at Sugarbush Resort in Warren, VTYear RoundIs your CV ready If so, and you are confident this is the role for you, make sure to apply asap.RESORT OVERVIEW:Sugarbush Resort is a year-round destination offering some of the best skiing and riding in the east, an award-winning ski school, mountain biking, golf, disc golf, an...
