Current jobs related to Senior Manager, Regulatory Operations - Lansing - Sumitomo Pharma

  • Senior Manager, Operational Risk Management

    3 months ago

    Lansing, United States First Merchants Bank Full time

    Job DescriptionJob DescriptionFirst Merchants Bank is seeking a Senior Manager, Operational Risk Management to join our team! This position will lead, implement and provide oversight in support of the lines of business for the company’s Operational Risk Management program and methodologies, with the intention of building a strong risk management culture...

  • Regulatory Affairs Specialist

    1 week ago

    Lansing, Michigan, United States Sparrow Health System Full time

    OverviewSparrow Health System is seeking a dedicated professional to oversee the regulatory compliance and Institutional Review Board (IRB) processes. This role is crucial in ensuring that our clinical trials adhere to the highest standards of practice.Key ResponsibilitiesManage all facets of regulatory submissions and maintain compliance with relevant...

  • Senior Vice President of Affordable Housing Operations

    1 week ago

    Lansing, Michigan, United States Presbyterian Villages of Michigan Full time

    Presbyterian Villages of Michigan, a faith-driven, leading nonprofit organization dedicated to providing senior living and services, presents an exceptional opportunity for a seasoned professional to step into the role of Senior Vice President of Affordable Housing Operations. We invite you to contribute to enhancing the quality of life for the seniors we...

  • Senior Facilities Operations Manager

    1 week ago

    Lansing, Michigan, United States BorgWarner Full time

    About UsBorgWarner stands as a global leader in providing innovative and sustainable mobility solutions tailored for the automotive sector. We are a collective of creative thinkers and innovators, uniting talented individuals, meaningful tasks, and cutting-edge technology within a distinctive environment. At BorgWarner, we are dedicated to realizing our...

  • Food Service Operations Manager

    10 hours ago

    Lansing, Michigan, United States Creative Dining Services Full time

    About the RoleCreative Dining Services is seeking a highly skilled and experienced Chef Manager to oversee the dining services operation at one of our esteemed clients. As a key member of our team, you will be responsible for ensuring that the highest standards of quality, customer satisfaction, and operational efficiency are maintained.Key...

  • Senior Manager Sales Operations

    1 month ago

    Lansing, Michigan, United States Ryder System Full time

    Job Seekers can review the Job Applicant Privacy Policy by clicking HERE. )\SummaryThe Senior Manager Sales Operations provides leadership and specialized expertise associated with the administration of sales systems, is responsible for financial reporting on all sales data for the assigned business segments and provides strategic consultation for all...

  • Regulatory Affairs Coordinator

    1 week ago

    Lansing, Michigan, United States Sparrow Health System Full time

    Job OpportunityPosition Overview:The Regulatory Affairs Coordinator plays a crucial role in overseeing the regulatory and Institutional Review Board (IRB) processes within clinical research settings. This position is essential for ensuring compliance with all applicable policies, procedures, and regulations related to Good Clinical Practice (GCP), as well as...

  • Chief Executive Officer

    3 days ago

    Lansing, Michigan, United States Commonwealth Senior Living Full time

    Position Overview:We are on the lookout for a dynamic leader to take on the role of Executive Director within our esteemed organization. This position is pivotal for those who are passionate about enhancing the lives of seniors and their families. If you possess a wealth of experience and a desire to lead, we encourage you to explore this opportunity. The...

  • Senior Facilities Operations Manager

    1 week ago

    Lansing, Michigan, United States BorgWarner Full time

    About BorgWarnerBorgWarner stands as a global leader in providing innovative and sustainable mobility solutions tailored for the automotive sector. Our organization thrives on the ingenuity of our workforce, fostering a culture of independent thought, collaboration, and cutting-edge technology to achieve our vision of a cleaner, energy-efficient future.Our...

  • Regulatory Document Coordinator

    7 days ago

    Lansing, United States ResourceMFG Full time

    summary Local company who is a leading manufacturer and distributor to the Cosmetic and Personal Care industry is looking for a Document Coordinator to join the team. Document Coordinator position is performance to hire, and company offer great benefits, room for growth and compensation. Regulatory Document Coordinator duties: Ensuring accuracy and...

  • Senior Loss Control Consultant Lansing, MI

    2 weeks ago

    Lansing, United States Alexander & Schmidt Full time

    Senior Loss Control Consultant Job Description At Alexander & Schmidt, a Senior Loss Control Consultant performs inspections and prepares in-depth reports for insurance underwriting purposes. Insurance companies use the reports to properly insure a commercial building or business operations for a new policy or renewal of a current policy. Required...

  • Senior Accounting Manager

    1 week ago

    Lansing, Michigan, United States Zobility Full time

    Position OverviewLeads, organizes, and engages in the financial activities of the accounting team as directed by the Accounting Manager, focusing on the acquisition, computation, documentation, and recording of financial data essential for maintaining accounting and statistical records through the execution of the following responsibilities.Key...

  • Operations Assistant Manager

    10 hours ago

    Lansing, Kansas, United States Kona Ice Full time

    Job Summary:Kona Ice is seeking a highly organized and detail-oriented individual to join our team as an Assistant Operations Manager. This role will support the General Manager in the day-to-day operation of the business, including maintaining inventory levels, developing client relationships, and delivering exceptional service through our special events...

  • Regulatory Compliance Officer

    3 days ago

    Lansing, Michigan, United States City of Lansing, MI Full time

    Career Opportunity as a Regulatory Compliance Officer at City of LansingKEY RESPONSIBILITIES:Perform inspections of properties to verify adherence to the City's housing, signage, and zoning regulationsOffer guidance to the public both verbally and in writing regarding zoning and signage regulationsExamine substandard housing situationsCompile inspection...

  • Senior Vice President of Finance and Accounting

    1 week ago

    Lansing, Michigan, United States The Jacobson Group Full time

    Job Overview:The Jacobson Group is in search of a Senior Vice President of Finance and Accounting. This pivotal role will offer strategic direction and oversight to the financial operations, focusing on the establishment of robust management and accountability frameworks to cultivate a high-performing, data-driven team. The successful candidate will possess...

  • Senior Project Management Supervisor

    1 week ago

    Lansing, Michigan, United States Test Products Inc Full time

    Company Overview:At Test Products Inc, we cultivate a workplace that emphasizes purpose and inclusivity.Position Summary:The Senior Project Management Supervisor is a pivotal leadership position responsible for guiding, managing, and enhancing the Project Management Team.This role acts as a crucial link between clients and the organization, ensuring timely...

  • Operations Management Professional

    9 hours ago

    Lansing, Michigan, United States Intelogix Corporation Full time

    Job SummaryWe are seeking a highly skilled Operations Management Professional to join our team at Intelogix Corporation. As an Assistant Operations Manager, you will play a critical role in supporting the overall performance achievement of our Customer Account Representatives, while also contributing to the efficient operation of our collection office.Key...

  • Senior IT Project Manager

    7 days ago

    Lansing, United States A-Line Staffing Solutions Full time

    Job Title: Senior IT Project Manager No C2C Overview: We are seeking a skilled Senior IT Project Manager to lead and oversee large, complex projects. This role involves managing project timelines, budgets, and integration with other systems. The projects typically l...

  • Financial Operations Manager

    1 week ago

    Lansing, Michigan, United States Delta Staffing Full time

    Delta Staffing is a forward-thinking cannabis enterprise focused on providing exceptional cannabis products and services. Our commitment to innovation, sustainability, and excellence drives our mission to positively influence the well-being of our community.Position Overview: We are seeking a skilled Financial Operations Manager to become a vital part of our...

  • Area Operations Manager

    1 week ago

    Lansing, Michigan, United States Ocean State Job Lot Full time

    Company Overview:Ocean State Job Lot is a leading retail company dedicated to providing value and quality products to our customers. With a commitment to community and excellence, we strive to create a positive shopping experience.We are currently seeking a skilled individual to oversee the management of a portfolio of retail locations in an efficient and...

Senior Manager, Regulatory Operations

1 month ago

Lansing, United States Sumitomo Pharma Full time

Sumitomo Pharma Senior Manager, Regulatory Operations Lansing, Michigan Apply Now Sumitomo Pharma Co., Ltd. is a global pharmaceutical company based in Japan with key operations in the U.S. (Sumitomo Pharma America, Inc.), Canada (Sumitomo Pharma Canada, Inc.) and Europe (Sumitomo Pharma Switzerland GmbH) focused on addressing patient needs in oncology, urology, women's health, rare diseases, psychiatry & neurology, and cell & gene therapies. Job Overview We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Senior Manager, Regulatory Operations. For assigned projects, the Senior Manager of Regulatory Operations is responsible for managing all Regulatory Affairs activities involving compilation, publishing, distribution, and archiving of health authority submissions. Job Duties and Responsibilities Overseeing the external Submission Managers with defining submission outlines, content, format, and quality requirements for electronic submissions, with input from Regulatory Affairs staff as needed. Manages the external Submission Managers to ensure the accurate and timely management of tracking, compiling, publishing, quality checking, dispatching, and archiving of Health Authority submissions. Facilitates submission preparation via completion of forms and creation of cover letters. Represents Regulatory Operations on project teams for matters relating to electronic (and paper) submissions. Overseeing the external Submission Managers to ensure accurate printing, distributing, and archiving all incoming and outgoing communications with FDA and international counterpart agencies. Leads in the implementation, validation, and operation of eCTD and electronic document management systems and other publishing and submissions technology projects. Leads the development, refinement, and implementation of internal processes, procedures, work instructions, and training programs for submission production and operational support activities. Understands evolving Health Authority (HA) standards and procedures for regulatory submissions and guides project teams on new requirements. Coordinating and consulting with other departments on the content, review, and assembly of regulatory documentation. Assisting in the creation of regulatory project plans and timelines for multiple projects or developmental programs. Leads the training of appropriate R&D staff in the application of various standards and technologies. Key Core Competencies Requires a detail-oriented self-starter with excellent organizational, planning, and follow-up skills, as well as communication, teamwork, and interpersonal skills. Ability to meet tight competing deadlines, juggle multiple priorities and multi-task. Extensive knowledge of regulatory submission publishing standards and procedures, including computer word processing, electronic document management systems, and regulatory publishing software. Education and Experience High School (Bachelor’s degree preferred). Minimum 8 years (without Master’s) or 6 – 8 years (with Master’s) of relevant experience in biotech or pharmaceutical industry. 7+ years’ experience in a fast-paced, high-volume document production environment. Compensation and Benefits The base salary range for this role is $126,600 to $155,000. Base salary is part of our total rewards package which includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, and various insurances. Our robust time-off policy includes unlimited paid time off and paid sick time upon hire. Compliance : Achieve and maintain compliance with all applicable regulatory, legal, and operational rules and procedures. Confidential Data : All information encountered is considered confidential. Equal Employment Opportunity : Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer. #J-18808-Ljbffr