Current jobs related to Senior Manager Regulatory Affairs Lead - Noblesville, Indiana - Curium Live Forward

  • Senior Manager Regulatory Affairs Lead

    4 weeks ago

    Noblesville, Indiana, United States Curium Live Forward Full time

    Job SummaryThe Senior Manager Regulatory Affairs will play a pivotal role in driving the success of key regulatory projects at Curium Live Forward. This position requires a highly skilled and experienced individual capable of navigating the complex regulatory landscape related to CMC.Key ResponsibilitiesManage submissions and projects as assigned by...

  • Senior Operations Manager

    4 weeks ago

    Noblesville, Indiana, United States Prime Car Wash Full time

    Job Title: Senior Operations ManagerPrime Car Wash is seeking a highly skilled Senior Operations Manager to lead our team of professionals in delivering exceptional customer experiences and driving business growth.Key Responsibilities:Manage day-to-day operations of the car wash facility, ensuring seamless execution of processes and procedures.Recruit,...

  • Director of Community Marketing

    4 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    Job Title: Director of Community MarketingAbout the Role:We are seeking a highly skilled and experienced Director of Community Marketing to join our team at American Senior Communities. As a key member of our marketing team, you will be responsible for developing and implementing marketing strategies to promote our senior living communities and services.Key...

  • Senior Operations Manager

    3 weeks ago

    Noblesville, Indiana, United States AEG Full time

    Job SummaryThe Senior Operations Manager will oversee the day-to-day operations of the Noblesville Event Center, ensuring a consistently superior and innovative experience for guests. This role is responsible for managing the venue's operations, including live entertainment booking, sales and sponsorship, event production, event management, and related...

  • LPN Evening Nurse

    3 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    LPN Evening Nurse Job DescriptionWe are seeking a compassionate and skilled LPN to join our team as an Evening Nurse. As a Licensed Practical Nurse, you will play a vital role in providing high-quality care to our residents, ensuring their physical and emotional well-being.Responsibilities:Deliver exceptional nursing care to residents, including...

  • Nurse Practitioner

    4 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    About the Role:As a Registered Nurse at American Senior Communities, you will have the opportunity to make a meaningful impact on the lives of our residents. We are seeking a compassionate and skilled nurse to join our team and provide top-notch medical attention and foster a nurturing environment.Responsibilities:Deliver exceptional nursing care to...

  • Nursing Director

    4 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    About the RoleWe are seeking a highly skilled and experienced Nursing Director to join our team at American Senior Communities. As a key member of our leadership team, you will be responsible for developing and implementing nursing policies and procedures that reflect current clinical practice and professional standards.Key ResponsibilitiesDevelop and...

  • Nursing Director of Patient Care Development

    2 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    As a key member of our nursing leadership team, you will play a vital role in shaping the future of patient care at American Senior Communities.About the Role:We are seeking an experienced Nursing Director of Patient Care Development to join our team. In this critical role, you will be responsible for developing, communicating, and maintaining nursing...

  • Caregiver for Seniors

    3 weeks ago

    Noblesville, Indiana, United States Visiting Angels Full time

    Companion Caregiver Job DescriptionAt Visiting Angels, we are seeking compassionate and dedicated individuals to join our team as Companion Caregivers. As a Companion Caregiver, you will have the opportunity to make a meaningful difference in the lives of senior adults and those in need.Responsibilities:Assist clients with daily living activities, such as...

  • HSE Manager

    3 weeks ago

    Noblesville, Indiana, United States Hamilton County Full time

    Safety Manager Job DescriptionHamilton County is a leading organization in the region, recognized for its excellence in various rankings. We are seeking a highly skilled and experienced Safety Manager to join our team.Key Responsibilities:Develop, implement, and maintain comprehensive safety programs, policies, and procedures.Conduct regular inspections and...

  • LPN Evening Position

    3 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    LPN Evening Position OverviewAt American Senior Communities, we are committed to delivering exceptional care to our residents. As a Licensed Practical Nurse (LPN) on our evening shift, you will play a vital role in enriching the lives of our residents by providing compassionate and detail-oriented care.Responsibilities:Deliver exceptional nursing care to...

  • Residential Area Manager

    3 weeks ago

    Noblesville, Indiana, United States ResCare Community Living Full time

    Job SummaryWe are seeking a highly skilled Residential Area Supervisor to join our team at ResCare Community Living. As a key member of our operations team, you will be responsible for overseeing the provision of assistance to individuals with developmental disabilities and ensuring the highest quality of care.The ideal candidate will have a strong...

  • Nurse Care Specialist

    4 weeks ago

    Noblesville, Indiana, United States American Senior Communities Full time

    Join Our Team as a Licensed Practical Nurse (LPN)We are seeking a compassionate and skilled Licensed Practical Nurse (LPN) to join our team at Riverwalk Village. As a LPN, you will play a vital role in providing high-quality care to our residents, promoting their physical and emotional well-being.Responsibilities:Deliver exceptional nursing care to...

  • Senior Travel Demand Modeler

    4 weeks ago

    Noblesville, Indiana, United States RS&H Full time

    Senior Travel Demand ModelerWe are seeking a highly skilled Senior Travel Demand Modeler to join our Transportation Planning practice. This role is open to multiple office locations.Key Responsibilities:Conduct and QA/QC advanced travel demand models, technical analyses, and reportsTravel demand model development, refinement, and managementScripting, coding,...

  • Senior Network Architect

    4 weeks ago

    Noblesville, Indiana, United States SMC Corporation of America Full time

    PurposeThe Senior Network Engineer will be responsible for ensuring the availability, performance, and stability of SMC's IT infrastructure to support the company's strategic goals.Responsibilities include the configuration and implementation of infrastructure services, including data center networks, campus networking, WAN connectivity, LANs, WLANs, and...

  • Global IT Manager

    4 weeks ago

    Noblesville, Indiana, United States SMC Corporation of America Full time

    PurposeThe Global Manager, Infrastructure & Architecture will lead a global team responsible for designing, implementing, and maintaining a standardized global computing environment, while delivering quality processes, controls, and system support to SMC Corporation of America globally.This position requires a strong business and technical knowledge, and a...

  • Safety Manager

    3 weeks ago

    Noblesville, Indiana, United States Hamilton County Full time

    Safety Manager Job DescriptionHamilton County is seeking a highly skilled and experienced Safety Manager to join our team. As a key member of our Legal Department, you will be responsible for developing, implementing, and maintaining comprehensive safety programs, policies, and procedures.Key Responsibilities:Develop and implement safety policies and...

  • Manufacturing Engineer Lead

    4 weeks ago

    Noblesville, Indiana, United States SMC Corporation of America Full time

    Job DescriptionAs a Manufacturing Engineer Lead at SMC Corporation of America, you will be responsible for defining and implementing manufacturing processes and procedures to ensure high-quality products and efficient production. This role requires strong technical knowledge, leadership skills, and the ability to work collaboratively with cross-functional...

  • Swim Instructor Team Lead

    4 weeks ago

    Noblesville, Indiana, United States Big Blue Swim School Full time

    Job OverviewAt Big Blue Swim School, we're dedicated to creating a supportive environment for our students and team members to thrive. As a Shift Lead, you'll play a crucial role in ensuring the smooth operation of our swim programs.Key ResponsibilitiesAssist Swim Instructors in delivering high-quality lessons and executing curriculumSupervise pool deck...

  • Operations Director

    3 weeks ago

    Noblesville, Indiana, United States Creative Financial Staffing Full time

    Operations Controller Job SummaryWe are seeking an experienced Operations Controller to join our Accounting & Finance Team at CFS Indianapolis. This role will support regional plant operations in Indianapolis, Southern Indiana, and Tennessee.About the CompanyOur client is a leading PE backed manufacturing company with over 75 years of experience and...

Senior Manager Regulatory Affairs Lead

2 months ago

Noblesville, Indiana, United States Curium Live Forward Full time
Job Title: Senior Manager Regulatory Affairs

Curium Live Forward is seeking a highly skilled Senior Manager Regulatory Affairs to join our team. As a key member of our Regulatory Affairs department, you will be responsible for leading the development and implementation of regulatory strategies for our Nuclear Medicine products.

Key Responsibilities:
  • Manage submissions and projects to ensure compliance with regulatory requirements
  • Represent regulatory affairs on cross-functional teams
  • Develop and implement regulatory strategies for CMC aspects of drug development and registration
  • Lead the preparation and submission of CMC sections of regulatory documents
  • Contribute to defining Target Product Profiles and building compliant drug dossiers
  • Serve as liaison for third-party service providers
  • Maintain associated databases for tracking individual and department project deliverables
  • Develop and implement policies, procedures, and practices for Regulatory Affairs
  • Manage multiple priorities, define issues and obstacles, and execute solutions
  • Communicate regulatory governmental policy changes to management and provide plans for meeting and complying with new requirements
Requirements:
  • Bachelor of Science in Chemistry, pharmacy, biology, or other life science, plus direct experience managing regulatory activities
  • Twelve or more years of relevant Regulatory Affairs pharmaceutical industry experience
  • Two years of supervisory experience of direct reports required, matrix management experience preferred
  • In-depth knowledge of global CMC regulatory requirements, guidelines, and industry practices
  • Experience in leading new project submission efforts, including strategy, compilation, submission, and approval by a health authority
Working Conditions:
  • Standard office environment
  • Willingness to work in a team-based environment
  • May be required to sit or stand for long periods of time while performing duties
  • Close attention to detail required
  • Must be able to work outside of regular work hours, including off-shift, weekend, and holiday work as business needs require