Lead Manager, Regulatory Affairs Operations

2 weeks ago

West Columbia, South Carolina, United States Takeda Pharmaceuticals Full time


**Company Overview:**
At Takeda Pharmaceuticals, we are dedicated to transforming patient care through innovative specialty pharmaceuticals and exceptional patient support programs.


**Position Overview:**
As the Lead Manager of Regulatory Affairs Operations, you will play a pivotal role within the Vaccine Business Unit (VBU), advancing the mission of Regulatory Operations by facilitating health authority submissions, registrations, and archival processes, as well as overseeing Veeva RIM processes and ensuring the accuracy of metadata in MEDIVA.


**Key Responsibilities:**
1. **Regulatory Operations Management:**
- Oversee all activities related to the planning, tracking, compilation, publishing, distribution, and archiving of submissions to health authorities.
- Collaborate with external publishing vendors to ensure timely publication and dispatch of submissions.
- Maintain comprehensive databases related to regulatory activities within a Regulatory Information Management (RIM) system.

2. **Project Management:**
- Independently manage projects by defining submission outlines, content, format, and quality standards for electronic submissions, with input from Regulatory Affairs teams as necessary.
- Ensure precise and timely management of the tracking, compiling, publishing, quality assurance, dispatching, and archiving of submissions.

3. **Cross-Departmental Coordination:**
- Consult with various departments to ensure the content, review, and assembly of regulatory documentation is consistent, complete, and adheres to established standards.
- Assist in the development of regulatory project plans and timelines for multiple projects, maintaining updates for senior management.

4. **Training and Development:**
- Participate in the creation and refinement of internal processes, procedures, and training programs to enhance submission production and operational support.
- Provide training to colleagues and project teams as required.

5. **System Support:**
- Support upgrades to the RIM system, including executing user acceptance testing for system releases and updating standard operating procedures to reflect changes.


**Qualifications:**
- Bachelor's degree in a relevant field.
- A minimum of 8 years of experience in the biotech or pharmaceutical sector.
- Proven ability to work independently and within a global, multicultural environment, delivering results in a matrix organization.
- Strong organizational, planning, and communication skills, with a detail-oriented approach.
- In-depth knowledge of regulatory submission standards and procedures, including electronic document management systems and regulatory publishing software.
- Familiarity with FDA and other health agency regulations governing submission content and format.


**Why Join Us?**
At Takeda, we are committed to fostering an inclusive and collaborative workplace, united by our mission to deliver better health and a brighter future for people worldwide. We offer competitive compensation and benefits, ensuring equitable pay and opportunities for growth.

  • Senior Regulatory Affairs Specialist

    3 days ago

    Columbia, South Carolina, United States Chamberlain University Full time

    About Chamberlain UniversityChamberlain University is a leading provider of professional talent to the healthcare industry. Our mission is to educate and empower students with the knowledge and skills to become leaders in their communities and make a lasting impact on public health, well-being, and beyond.Job SummaryThe Senior Regulatory Affairs Specialist...

  • Director of Regulatory Affairs

    2 months ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Job SummaryThe Director of Regulatory Affairs is responsible for planning, organizing, implementing and evaluating regulatory compliance initiatives to support patient safety and quality and ensure continuous compliance with Federal, State and local regulatory requirements. This position concentrates on oversight of accreditation and certification processes,...

  • Head of Compliance and Regulatory Affairs

    2 weeks ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Position OverviewThe Director of Regulatory Affairs plays a pivotal role in orchestrating, managing, and assessing compliance initiatives aimed at enhancing patient safety and quality. This leadership position ensures adherence to Federal, State, and local regulatory standards while focusing on accreditation and certification processes.Key...

  • Chief of Surgery

    7 hours ago

    West Columbia, South Carolina, United States Department of Veterans Affairs Full time

    Job SummaryWe are seeking a highly experienced and skilled Chief of Surgery to lead our surgical department at the Department of Veterans Affairs. As a key member of our leadership team, you will be responsible for overseeing surgical procedures, pre-operative and post-operative care, and administrative responsibilities.Key ResponsibilitiesOversee surgical...

  • Medical Affairs Strategist

    5 days ago

    Columbia, South Carolina, United States GForce Life Sciences Full time

    About the RoleGForce Life Sciences is seeking a highly experienced Medical Affairs Consultant to join our team. As a Medical Affairs Strategist, you will play a critical role in defining and executing our medical strategy, working closely with our Executive Director, Medical Strategy Lead.Key ResponsibilitiesDevelop and Execute Medical Strategy: Collaborate...

  • Regulatory Compliance Specialist

    2 weeks ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist will play a crucial role in overseeing compliance and implementing strategies to ensure that Medpoint, LLC adheres to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance with medical device regulations,...

  • Regulatory Compliance Specialist

    1 week ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a crucial role in overseeing regulatory issues and implementing strategies to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance with medical device regulations,...

  • Head of Regulatory Compliance

    1 week ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Position OverviewThe Director of Regulatory Affairs plays a crucial role in strategizing, executing, and assessing compliance initiatives aimed at enhancing patient safety and maintaining high-quality standards. This leadership position is pivotal in ensuring adherence to federal, state, and local regulations.Key ResponsibilitiesOversee accreditation and...

  • Regulatory Compliance Specialist

    2 weeks ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a crucial role in overseeing compliance with regulatory standards and implementing strategic initiatives to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance...

  • Regulatory Compliance Specialist

    1 week ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a crucial role in overseeing regulatory issues and implementing strategies to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The role requires ensuring compliance with medical device regulations,...

  • Regulatory Compliance Specialist

    1 week ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a pivotal role in overseeing regulatory compliance and the execution of strategic initiatives to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance with medical...

  • Head of Regulatory Compliance

    2 weeks ago

    Columbia, South Carolina, United States Johns Hopkins Medicine Full time

    Position OverviewThe Director of Regulatory Affairs plays a crucial role in the strategic planning, organization, execution, and assessment of compliance initiatives aimed at safeguarding patient welfare and enhancing quality standards. This leadership position is pivotal in ensuring adherence to Federal, State, and local regulatory mandates.Key...

  • Regulatory Compliance Specialist

    1 week ago

    Columbia, South Carolina, United States Medpoint, LLC Full time

    The Regulatory Affairs Specialist at Medpoint, LLC will play a pivotal role in overseeing compliance with regulatory standards and implementing strategic initiatives to ensure adherence to relevant regulations. Key responsibilities include managing regulatory submissions, registrations, and listings on a global scale. The specialist will ensure compliance...

  • Banking Center Manager

    4 days ago

    Columbia, South Carolina, United States First Horizon Bank Full time

    About the RoleWe are seeking a highly motivated and experienced Banking Center Manager to lead our team to success. As a key member of our organization, you will be responsible for driving business growth, building strong relationships with clients, and overseeing all banking center functions.Key ResponsibilitiesBusiness Development: Develop and implement...

  • Primary Care Physician Opportunity at the Department of Veteran Affairs

    1 day ago

    Columbia, South Carolina, United States Department of Veteran Affairs Full time

    Job SummaryThe Department of Veteran Affairs is seeking a highly skilled Primary Care Physician to join our team at the WJB Dorn VA Medical Center in Columbia, SC. As a Primary Care Physician, you will be responsible for delivering high-quality patient care to our nation's veterans, providing comprehensive primary care services, and working collaboratively...

  • Automotive Operations Manager

    5 days ago

    West Columbia, South Carolina, United States Grimaud Enterprises, Inc. Full time

    We are seeking a highly skilled and experienced Automotive Service Manager to join our team at Grimaud Enterprises, Inc. As a key member of our management team, you will be responsible for leading our service department to deliver exceptional customer experiences and drive business growth.Key Responsibilities:Lead and manage a team of service advisors,...

  • Senior Manager of Operations

    2 weeks ago

    West Columbia, South Carolina, United States The Judge Group Full time

    Location: Columbia, SCSalary: $150,000.00 USD Annually - $160,000.00 USD AnnuallyDescriptionThe Judge Group is in search of a qualified Senior Manager of Operations for a prominent manufacturing organization in South Carolina. The ideal candidate will oversee and direct all aspects of production activities, ensuring product excellence and optimizing...

  • Compliance Manager

    1 week ago

    Columbia, South Carolina, United States Search Solution Group Full time

    Compliance Manager - Regulatory ExpertWe are seeking a highly skilled Compliance Manager to join our team at Search Solution Group. As a key member of our organization, you will play a critical role in ensuring our compliance with regulatory requirements and industry standards.Key Responsibilities:Collaborate with business partners to develop and implement...

  • Rheumatology Department Head

    5 days ago

    West Columbia, South Carolina, United States Department of Veterans Affairs Full time

    Job SummaryWe are seeking a highly skilled and experienced Rheumatologist to serve as Chief of Rheumatology at the Department of Veterans Affairs. As a key member of our healthcare team, you will provide leadership and direction to the Division of Rheumatology, overseeing clinical, educational, and research activities.Key ResponsibilitiesProvide clinical...

  • Financial Operations Manager

    2 weeks ago

    West Columbia, South Carolina, United States Penn Foster Inc Full time

    Position Overview: The Financial Operations Manager is responsible for overseeing and directing all accounting activities within the organization. This includes the preparation of monthly financial reports, compliance with regulatory requirements, and management of budgeting processes.Key Responsibilities: - Direct the financial statement close-out process...