![BD (Becton, Dickinson and Company)](https://contents.bebee.com/companies/us/bd-becton-dickinson-and-company/avatar-8NPk1.png)
Staff Regulatory Specialist
4 weeks ago
Job Description Summary
This position is responsible for managing the various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of healthTM is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Purpose of Position :
This position is responsible for managing the various regulatory activities for new and existing combination devices and/or pharmaceuticals including but not limited to healthcare antiseptic products.
General Functions, Specific Responsibilities, and Authority :
- Review CMC changes and determine regulatory reporting category in accordance with FDA guidance for changes to an approved (A)NDA
- Write domestic device and drug regulatory submissions including NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses.
- Determine deliverables for regulatory submissions and communicate to appropriate functional representatives to ensure timely and accurate submissions per business objectives.
- Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes.
- Support OUS RA team members in order to maintain effective collaboration and to synchronize domestic and international submissions.
- Review and Approve Labeling and Advertising and Promotional materials for compliance to internal procedures.
- Manage and maintain the drug registrations and listings (CDER Direct/eDURLS) system and complete CARES Act reporting.
- Support the submission of SPL via ESG/CDER Direct for all drug labeling in the US.
- Evaluate and prepare procedures pertaining to corporate and departmental regulatory activities.
- Monitor applicable regulatory requirements; assure compliance with corporate and external standards and guidance documents.
- Support the quality system and internal/external audits.
Knowledge, Education, and Skills Required :
- Excellent organizational and communications skills.
- Candidate should be able to work independently, support project teams, to address and communicate problems and complex issues in a concise and effective manner, to manage multiple projects/tasks simultaneously, and effectively manage and prioritize regulatory submission projects.
- Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required.
- Experience navigating FDA databases required.
- Experience with EU MDR preferred.
- Experience with electronic submissions and ERP systems is preferred.
Education:
- Minimum BS required in science, such as Chemistry, Biology, Microbiology, or engineering. Masters Preferred.
Skills:
- Strong attention to detail and Excellent organizational skills
- History of successful regulatory submissions
- Project management of regulatory submissions with minimal guidance
- Effective verbal and written presentation and communication skills Comprehensive coordination and compilation of documentation
Experience:
- Minimum of 5 years' experience in Regulatory Affairs in Combination Products and/or Pharmaceuticals
- Minimum of 5 years' experience working with the FDA CDER
- Strong working knowledge of US and International regulations and guidance, such as 21 CFR 820, ISO 13485, ICH guidelines and 21 CFR 210/211
- Internal auditing experience a plus
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
#earlycareer
Primary Work Location
USA IL - Vernon Hills
Additional Locations
USA TX - El Paso - Northwestern Dr.
Work Shift
NA (United States of America)
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
-
Specialist I, Service Center System
4 weeks ago
Vernon Hills, Illinois, United States Sysmex America, Inc Full timeSpecialist I, Service Center System - TEMPJob Location(s)US-IL-Vernon Hills# of Openings3Job ID CategoryInternal Service CenterTravel25%OverviewFind a Better Way... use your skills and experience. This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using...
-
Junior Category Management Specialist
1 week ago
Vernon Hills, Illinois, United States Graham Enterprise Inc. Full timeJob OverviewPosition Title: Junior Category Management Specialist, Graham Enterprise, Inc. (GEI)Role Summary: This role is pivotal in executing marketing strategies at the category level. A successful Junior Category Management Specialist at GEI plays a significant role in enhancing the profitability of retail locations by boosting product sales within...
-
Compliance Inspection Specialist
1 week ago
Vernon Hills, Illinois, United States MTM LLC Full timeWelcome to MTM LLCWe are excited to announce an opportunity for a detail-oriented and organized individual to join our team as an Inspection Coordinator. In this pivotal role, you will oversee the inspection processes for our solar energy projects, ensuring that everything runs smoothly and efficiently.Key Responsibilities:Inspection Scheduling: Organize and...
-
Ingredient Mixing Specialist
1 week ago
Vernon Hills, Illinois, United States Proman Staffing Full timePosition OverviewPROMAN Staffing is collaborating with a prominent producer of Italian cuisine.We are currently seeking Mixer Operators who demonstrate teamwork, adaptability, and reliability.Role SummaryCompensation: $18 / HRShift: 6:00 am to 2:30 pmWork Schedule: Monday - FridayResponsibilities include:Mixing IngredientsSetting Up EquipmentMaintaining...
-
Ingredient Mixing Specialist
1 week ago
Vernon Hills, Illinois, United States Proman Staffing Full timePosition OverviewPROMAN Staffing is collaborating with a reputable producer of Italian cuisine.We are currently seeking Mixer Operators who are reliable, adaptable, and work well in a team environment.Role SummaryCompensation: $18 / HRShift: 6:00 am to 2:30 pmSchedule: Monday - FridayResponsibilities include:Mixing various ingredientsSetting up...
-
Customer Engagement Specialist
4 days ago
Vernon Hills, Illinois, United States TJX Companies, Inc. Full timeAbout Us: At TJX Companies, Inc., we are dedicated to creating a welcoming environment where style and quality meet affordability. Our commitment to our customers is reflected in our more than 500 stores, where we strive to make every shopping experience unique and enjoyable.Role Overview: As an Engagement Coordinator, you will play a pivotal role in...
-
Veterinary Support Specialist
1 week ago
Vernon Hills, Illinois, United States Mission Veterinary Partners Full timeOverview Mission Veterinary Partners is looking for a dedicated Veterinary Assistant to become a vital part of our team. We are thrilled to invite a new member to our family. Our staff is deeply committed to animal welfare and delivering exceptional medical care. We are proud to be AAHA Accredited and Cat Friendly certified, and we are on the...
-
Pediatric Dentist Opportunity
4 days ago
Vernon Hills, Illinois, United States North American Dental Group Full timeAbout the OpportunityWe are seeking a highly skilled and dedicated Pediatric Dentist to join our team at North American Dental Group.Why Choose UsPractice Group Dentistry - We offer a collaborative and supportive environment where you can focus on providing exceptional patient care.Best-in-Class Dentistry - We are committed to staying at the forefront of...
-
Imaging Specialist
1 week ago
Mt. Vernon, Illinois, United States SSM Health Full timeTransforming Healthcare Through ImagingLocation: SSM Health Express ClinicEmployment Type:Regular Full-TimeIncentives:$10,000 Sign-On Bonus Available for Eligible CandidatesShift Details:Full-Time, 8 AM - 8 PM, with rotating weekends and holidays.Position Overview:The Imaging Specialist is responsible for capturing diagnostic images of specific areas of the...
-
Pre Closing Specialist
4 days ago
Mt. Vernon, Illinois, United States Peoples National Bank Full timeJob Summary:We are seeking a highly organized and detail-oriented Pre Closing Specialist to join our team at Peoples National Bank. As a key member of our commercial lending team, you will be responsible for preparing loan documentation, reviewing and verifying information, and ensuring accurate loan documents in the loan application process.Key...
-
Healthcare Support Specialist
1 week ago
Mt. Vernon, Illinois, United States SSM Health Full timeSSM Health - 1 Good Samaritan WayAs a Healthcare Support Specialist at SSM Health, your responsibilities will include:Data Collection: Gather and document essential information for patient admission assessments and ongoing evaluations.Patient Monitoring: Notify licensed nursing staff of any alterations in patient conditions or requirements.Supply Management:...
-
Therapeutic Respiratory Specialist
1 week ago
Palos Hills, Illinois, United States BRIA Full timeAbout Us:At BRIA, we prioritize community engagement and emphasize a healthy work-life balance. Our facilities are designed to provide a nurturing atmosphere, empowering our staff to deliver exceptional care.Benefits for the Therapeutic Respiratory Specialist:- Comprehensive PTO package and paid holidays- Employee recognition program- Opportunities for...
-
Nursing Admissions Specialist
1 week ago
Palos Hills, Illinois, United States BRIA Full timeAt BRIA, we prioritize community engagement and strive for a healthy work-life balance. Our skilled nursing facilities provide a nurturing atmosphere, empowering our staff to deliver exceptional care.Benefits for the Nursing Admissions Specialist (RN):Comprehensive Medical/Dental/Life/Vision insuranceNext day pay option availableEmployee recognition...
-
Educational Support Specialist
1 week ago
Mt. Vernon, Illinois, United States Rebecca School Full timeRebecca School is a specialized educational institution that employs the DIRFloortime approach pioneered by Dr. Stanley Greenspan. We are currently expanding our team and are looking for dedicated individuals to fill the role of Educational Support Specialist. This position involves working with students aged 3 to 21 who experience neuro-developmental...
-
Communication Specialist in Education
4 days ago
Mt. Vernon, Illinois, United States Mount Vernon City School District Full timeObjective: The Communication Specialist in Education plays a crucial role in enhancing speech and language capabilities to support the personal, social, and cognitive growth of students. To effectively address the unique needs and skills of each student, the Communication Specialist collaborates closely with the educational staff and...
-
Cytology Technical Specialist
4 days ago
Mt. Vernon, Illinois, United States SSM Health Full timeJob Overview:At SSM Health, we believe in more than just a job; we are committed to a mission. As a Cytology Technical Specialist, you will play a vital role in our laboratory team, ensuring high-quality patient care through expert cytological analysis.Position Highlights:Sign-on Bonus: Eligible for a $10,000 sign-on bonus for external qualified...
-
Traveling CT Imaging Specialist
1 week ago
Mt. Vernon, Illinois, United States Host Healthcare Full timePosition Overview:Host Healthcare is currently seeking a traveling CT Imaging Specialist for an exciting opportunity.Job Details:Specialty: CT Imaging SpecialistDiscipline: Allied Health ProfessionalDuration: 13 weeksWeekly Hours: 36 hoursShift: 12 hours, daysEmployment Type:This position is a travel role with Host Healthcare, a leading travel healthcare...
-
Pulmonary Care Specialist
1 week ago
Palos Hills, Illinois, United States BRIA Full timePosition OverviewJoin BRIA, where we prioritize community engagement and a healthy work-life balance. Our facilities are dedicated to providing a nurturing environment that empowers both staff and residents.Benefits for Pulmonary Care Specialists:Generous paid time off and holiday payIncentive programs for employeesOpportunities for internal...
-
MRI Imaging Specialist
1 week ago
Mt. Vernon, Illinois, United States Skagit Regional Health Full timeDepartment: MRI Labor Joint Venture SVH Exempt: No Schedule:VARIABLEPosition Type: Per Diem /PRNFTE:Base Wage $43.32 to $62.86 Location: Skagit Valley Hospital The following outlines the essential responsibilities and qualifications for the MRI Imaging Specialist role. This position is designed to ensure that the individual is clinically proficient and...
-
Rehabilitative Nursing Specialist
1 week ago
Palos Hills, Illinois, United States BRIA Full timePosition OverviewSign-on Bonus: Up to $3,000*At BRIA, we prioritize community engagement and promote a healthy work-life balance. Our mission is to provide compassionate care, positively impacting the lives of the elderly each day.Benefits for Rehabilitative Nursing Specialists:Comprehensive Medical, Dental, Life, and Vision Insurance401(k) Retirement...