US Regulatory Affairs Manager
1 week ago
Lundbeck is a global biopharmaceutical company dedicated to advancing brain health and improving the lives of people with neurological and psychiatric diseases.
Job Description:Senior Manager, Regulatory Strategy (US RA)The Senior Manager, Regulatory Strategy (US RA) plays a crucial role in ensuring the successful US development and approval of assigned drug and biological products. This includes participating on global cross-functional teams, maintaining compliance with regulatory requirements, and providing expert advice on US regulatory matters.
Main Responsibilities:- Provides regulatory review of product documentation for accuracy and compliance with FDA regulations.
- Manages US regulatory perspective at Regulatory Affairs Focus Team meetings and represents the company's interests.
- Identifies risk, problem-solves, and offers solutions to ensure successful regulatory submissions.
- Serves as US subject matter expert to support strategy development and execution for assigned products.
- Accredited Bachelor's Degree in a relevant field.
- 7+ years of experience in the pharmaceutical and/or biotech industry or a consulting company supporting the pharmaceutical and/or biotech industry.
- 5+ years of direct experience in US Regulatory Affairs.
Lundbeck offers a comprehensive benefits package, including flexible paid time off, health benefits, and a 401(k) plan. We are committed to equal employment opportunity and participate in E-Verify.
-
Saugus, Massachusetts, United States LanzaJet, Inc. Full timeJob SummaryWe are seeking a highly skilled Corporate Affairs & Marketing Specialist to join our team at LanzaJet, Inc. in Deerfield, IL.This role is responsible for supporting the Vice President of Corporate Affairs and other members of the Corporate Affairs and Marketing team in positioning LanzaJet as a global leader in Sustainable Aviation Fuels (SAF)...
-
Care Coordinator Specialist
7 days ago
Saugus, Massachusetts, United States Bridgewell Full timeJob SummaryWe are seeking a compassionate and dedicated Care Coordinator Specialist to join our team at Bridgewell. As a key member of our staff, you will provide essential support and assistance to individuals with developmental or psychiatric disabilities in Level 2 residential programs.About the RoleThis rewarding role involves providing daily...
-
Utility Billing Manager
3 days ago
Saugus, Massachusetts, United States Town of Saugus Full timeAbout UsThe Town of Saugus is a vibrant community located in Essex County, Massachusetts. Our town prides itself on its strong sense of community and commitment to excellence in public service.Job SummaryWe are seeking a highly skilled Utility Billing Manager to join our team! As a key member of our Treasurer/Collector's Office, you will be responsible for...
-
Restaurant Operations Manager
3 days ago
Saugus, Massachusetts, United States Raising Cane's Full timeRole OverviewThe Operations Manager plays a vital role in ensuring the smooth operation of our restaurant, upholding Raising Cane's standards and culture in all aspects of restaurant operations.Key ResponsibilitiesSupports the Restaurant Leader in driving operational excellence.Executes restaurant operations functions, including managing cash handling and...
-
Grounds Management Professional
6 days ago
Saugus, Massachusetts, United States WeedMan - Gurnee, Il Full timeAbout the Role">Job Title: Grounds Management Professional">This is a challenging and rewarding opportunity for an experienced Grounds Management Professional to join our team at WeedMan - Gurnee, Il as a Lawn Care Operations Manager.">About You">You have a proven track record of success in managing teams and overseeing daily operations with a focus on...
-
Technical Product Information Manager
1 week ago
Saugus, Massachusetts, United States Essendant Management Services LLC Full timeEssendant Management Services LLCAbout the RoleWe are seeking a highly skilled Technical Product Information Manager to join our team. As a key member of our organization, you will be responsible for ensuring the accuracy and consistency of product information across all channels.Key Responsibilities:Data Management: Assist in the development,...
-
Overnight Residential Support Specialist
7 days ago
Saugus, Massachusetts, United States Bridgewell Full timeBridgewell OpportunityEstimated Salary: $45,000 - $55,000 per yearWe are seeking an experienced Overnight Residential Support Specialist to join our team. This role is responsible for providing support and assistance to individuals with developmental and psychiatric disabilities during the overnight hours in Level 2 residential programs.Job SummaryThe...
-
Clinical Stabilization Services Nurse
7 days ago
Saugus, Massachusetts, United States Spectrum Health Systems Full timeSpectrum Health Systems is a leading provider of mental health and substance abuse services.We are seeking a highly skilled Clinical Stabilization Services Nurse to join our team in Westborough, MA.About the JobThis is a per diem (as needed/on call) position with an estimated salary range of $31.00 - $35.00 per hour.The successful candidate will have...
-
Clinical Social Worker
7 days ago
Saugus, Massachusetts, United States Mass General Brigham Full timeCompensation: $120,000 per yearAbout the RoleWe are seeking a highly skilled Clinical Social Worker to join our care management team at Mass General Brigham. As a key member of our ambulatory primary care team, you will work closely with clinical and administrative staff to enhance patient care services.Your primary responsibilities will include identifying...
-
Direct Support Professional 2 Specialist
1 week ago
Saugus, Massachusetts, United States Bridgewell Full time**Job Overview**Bridgewell is a leading provider of social and human services that empower people with disabilities and life challenges to live safe, self-directed, and productive lives.We offer an unmatched range of programs, including community housing, day services, outpatient treatment, recovery services, education, and employment training. Our team is...
-
Senior Software Engineering Manager
1 week ago
Saugus, Massachusetts, United States Discover Financial Services Full time**About the Role**At Discover Financial Services, we're on a mission to create brighter financial futures for millions of people around the world. We're looking for a talented Senior Software Engineering Manager to join our team and help drive innovation in our digital banking and payments business.**Key Responsibilities**Oversee the design and...
-
Education Leader
7 days ago
Saugus, Massachusetts, United States The Goddard School of Saugus, MA Full timeJob Title: Education Leader - Saugus, MAAbout The Goddard School:The Goddard School of Saugus, MA is seeking an experienced and passionate Education Leader to join our team. As a leader in early childhood education, we prioritize providing a nurturing environment that fosters growth, development, and a lifelong love of learning.Salary Range: $65,000 -...
-
Restaurant Operations Manager
1 week ago
Saugus, Massachusetts, United States Raising Cane's Full timeOverviewRaising Cane's is a rapidly growing company dedicated to serving the best tasting and most craveable chicken finger meals. Our culture makes us unique, and our community is what makes it all worthwhile.
-
LPN Healthcare Professional
7 days ago
Saugus, Massachusetts, United States Bridgewell Full timeBridgewell MissionBridgewell strengthens communities by providing an unmatched range of social and human services empowering people with disabilities and life challenges to live safe, self-directed, and productive lives.We deliver support through community housing, day programs, outpatient treatment, recovery services, education, and employment training. Our...
-
Digital Communications Strategist
6 days ago
Saugus, Massachusetts, United States Swoon Full timeAbout the RoleWe are seeking a highly skilled Digital Communications Strategist to join our team as a Marketing Campaigns Manager.Location: Riverwoods, IL (Hybrid)Duration: 6 Months (possible extension)Pay Rate: $74/hKey Responsibilities:Deliverables Management: Manage schedules and adhere to processes to ensure timely and accurate completion of...
-
Urban Development Specialist
6 days ago
Saugus, Massachusetts, United States Town of Saugus Full timeRole OverviewThis position serves as the Town's point of contact and manager for all aspects of urban development, land use planning, and community growth initiatives.The successful candidate will be responsible for coordinating efforts to attract desired economic development, developing sound approaches to development, and assessing proposals for...
-
Water Meter Installation Specialist
7 days ago
Saugus, Massachusetts, United States Town of Saugus Full timeAbout the RoleWe are seeking a highly skilled Water Meter Installation Specialist to join our team in the Town of Saugus. This is a full-time position that requires strong technical knowledge and excellent customer service skills.Job SummaryThe successful candidate will be responsible for installing, replacing, and repairing water meters in the field. They...
-
Saugus, Massachusetts, United States TITLE Boxing Club Full timeAbout Us:TITLE Boxing Club International (TBCI) was ranked #1 Fastest Growing Franchise in America, as ranked by Inc. Magazine in 2015. We offer explosive boxing and kickboxing group workouts to women and men across the US in our dynamic, modern franchise locations. Our people have heart, and every owner, trainer, general manager, sales, and marketing person...
-
Pricing Analyst
4 days ago
Saugus, Massachusetts, United States Discover Financial Services Full timeAbout Discover Financial ServicesWe value what makes you unique so that you have an opportunity to shine. At Discover, we want you to grow and make a difference at one of the world's leading digital banking and payments companies.Job Description:Our team is looking for a skilled Pricing Analyst - Strategic Revenue Growth to join our ranks. In this role, you...
-
Department Leader
1 week ago
Saugus, Massachusetts, United States THE PAPER STORE Full timeJob SummaryWe are seeking an experienced Department Manager to lead our retail team at The Paper Store. As a key member of our sales floor, you will be responsible for delivering exceptional customer experiences, driving sales growth, and maintaining high levels of operational efficiency.About The Paper Store: We are a specialty retailer dedicated to...