We have other current jobs related to this field that you can find below

  • Financial Analyst for Academic Affairs

    5 days ago

    Lawrenceville, Georgia, United States Georgia Gwinnett College Full time

    Job Overview: Academic Affairs Financial Analyst The Academic Affairs Financial Analyst is responsible for supporting the financial management of budgets and transactions within the academic sector. This position involves a variety of administrative tasks that assist in the overall financial operations of the institution. Key Responsibilities ...

  • Budget Specialist for Academic

    3 months ago

    Lawrenceville, United States Georgia Gwinnett College Full time

    Job Summary The Academic and Student Affairs Budget Specialist's primary responsibility is to assist the Provost in the administration of budgets and all financial transactions and reports. This Specialist also performs a variety of administrative duties that support the Provost. Responsibilities Function 1 -  Monitors all budgets for the...

  • Regulatory Compliance Specialist

    5 days ago

    Lawrenceville, Georgia, United States The RMN Agency Full time

    Job OverviewOur client, a prominent Convenience Store Operator, is seeking a full-time Regulatory Compliance Specialist for their office in Lawrenceville, GA.Key ResponsibilitiesThis role requires an experienced Paralegal or Legal Administrator with a minimum of three years in administrative and licensing functions. The primary duties include:Managing...

  • Budget Specialist for Academic

    27 minutes ago

    Lawrenceville, Georgia, United States Georgia Gwinnett College Full time

    Job SummaryThe Academic and Student Affairs Budget Specialist plays a crucial role in ensuring the effective management of budgets and financial transactions within the academic and student affairs department at Georgia Gwinnett College.Key ResponsibilitiesMonitor and analyze budgets to ensure funds availability and proper account chargingPrepare and submit...

  • Outsourcing Manager

    7 days ago

    Lawrenceville, United States Proclinical Staffing Full time

    Outsourcing Manager - Contract - Lawrenceville, NJ Proclinical is seeking an Outsourcing Specialist to lead the team. Primary Responsibilities:In this role, the successful candidate will be responsible for managing outsourcing activities, ensuring compliance with regulatory standards, and driving the success of projects. This position requires strong...

  • Clinical Manager, RN

    2 days ago

    Lawrenceville, United States Affinity Hospice Full time

    Overview:CLINICAL MANAGERAffinity Hospice is actively looking for a Clinical Manager who is passionate about giving exceptional care to our hospice patients. Affinity Hospice one of the fastest growing, privately held hospice organizations in the country. We are passionate about patient and family care. We believe the care we provide truly matters. This is...

  • Clinical Manager, RN

    2 days ago

    Lawrenceville, United States Affinity Hospice Full time

    Overview:CLINICAL MANAGERAffinity Hospice is actively looking for a Clinical Manager who is passionate about giving exceptional care to our hospice patients. Affinity Hospice one of the fastest growing, privately held hospice organizations in the country. We are passionate about patient and family care. We believe the care we provide truly matters. This is...

  • Clinical Manager, RN

    5 days ago

    Lawrenceville, United States Affinity Hospice Full time

    Overview:CLINICAL MANAGERAffinity Hospice is actively looking for a Clinical Manager who is passionate about giving exceptional care to our hospice patients. Affinity Hospice one of the fastest growing, privately held hospice organizations in the country. We are passionate about patient and family care. We believe the care we provide truly matters. This is...

  • Clinical Manager, RN

    2 days ago

    lawrenceville, United States Affinity Hospice Full time

    Overview:CLINICAL MANAGERAffinity Hospice is actively looking for a Clinical Manager who is passionate about giving exceptional care to our hospice patients. Affinity Hospice one of the fastest growing, privately held hospice organizations in the country. We are passionate about patient and family care. We believe the care we provide truly matters. This is...

  • Clinical Manager, RN

    5 days ago

    Lawrenceville, United States Affinity Hospice Full time

    Overview:CLINICAL MANAGERAffinity Hospice is actively looking for a Clinical Manager who is passionate about giving exceptional care to our hospice patients. Affinity Hospice one of the fastest growing, privately held hospice organizations in the country. We are passionate about patient and family care. We believe the care we provide truly matters. This is...

  • Benefits Manager

    2 weeks ago

    Lawrenceville, United States Robert Half Full time

    The Benefits Manager will be responsible for designing, implementing, and managing comprehensive employee benefits programs. The ideal candidate will have extensive experience in benefits design and a strong background in working with insurance brokers to optimize plan offerings. This role requires a strategic thinker with excellent communication skills,...

  • Senior Financial Operations Manager

    6 days ago

    Lawrenceville, Georgia, United States Randstad Full time

    Position Overview:Randstad Finance & Accounting (Tatum) is in search of a dynamic and experienced Senior Financial Operations Manager to join a leading vegetation management firm. This role is pivotal in steering the financial health of the organization and leading a proficient accounting team.Key Responsibilities:Oversee the preparation, analysis, and...

  • Academic Financial Analyst

    6 days ago

    Lawrenceville, Georgia, United States Georgia Gwinnett College Full time

    Job Overview: Academic Financial Operations Specialist The Academic Financial Operations Specialist is tasked with supporting the Provost in overseeing financial resources and transactions within the academic sector. This position encompasses a variety of administrative responsibilities that aid the Provost in maintaining fiscal integrity. Core...

  • Practice Manager

    3 months ago

    Lawrenceville, United States SPCPSoutheast Medical Group Full time

    Job DescriptionJob DescriptionDescription:Responsible for the daily operation and maintenance of small to medium clinic practice(s) generally comprised of up to approximately 4-7 physicians, supervision of staff members, implementation of cost control measures, monitoring and adherence to patient care quality standards, problem resolution, and all duties to...

  • Assistant Store Manager

    3 weeks ago

    Lawrenceville, United States Big Dave's Cheesesteaks Full time

    Job DescriptionJob DescriptionWe are looking for a talented Assistant Store Manager to become part of our team in Lawrenceville, GA, US. The perfect candidate will be responsible for managing all operational aspects of the store while working closely with the General Manager.Compensation:$40,000 yearly + Bonus EligibleResponsibilities:Manage all operational...

  • Assistant Store Manager

    2 months ago

    Lawrenceville, United States Big Dave's Cheesesteaks Full time

    Job DescriptionJob DescriptionWe are seeking a skilled Assistant Store Manager to join our team in Lawrenceville, GA, US. The ideal candidate will oversee all operational facets of the store in collaboration with the General Manager.Compensation:$40,000 yearly + Bonus EligibleResponsibilities:Manage all operational aspects of the store alongside the General...

  • General Manager of Food and Nutrition

    4 days ago

    Lawrenceville, United States Morrison Healthcare Full time

    Join MORRISON HEALTHCARE, the nation's Premier and Largest healthcare food service company, dedicated to providing high-quality, nutritious meals that enhance patient care and staff well-being. We are committed to innovation, excellence, and creating a positive impact on the lives of those we serve.Position Overview: We are seeking an experienced and dynamic...

  • General Manager of Food and Nutrition

    1 week ago

    Lawrenceville, United States Morrison Healthcare Full time

    Join MORRISON HEALTHCARE, the nation's Premier and Largest healthcare food service company, dedicated to providing high-quality, nutritious meals that enhance patient care and staff well-being. We are committed to innovation, excellence, and creating a positive impact on the lives of those we serve.Position Overview: We are seeking an experienced and dynamic...

  • Vice President of Claims Quality Management

    6 days ago

    Lawrenceville, Georgia, United States CorVel Enterprise Comp, Inc. Full time

    Position OverviewThe Vice President of Claims Quality Management plays a pivotal role in shaping and enhancing claims processing standards and adherence to regulations. This leadership position is crucial for guiding field management on quality claims processing while fostering strong relationships with insurance partners to ensure compliance with...

  • Bilingual Lead Case Manager

    2 weeks ago

    Lawrenceville, United States National Youth Advocate Program Full time

    Working At NYAP NYAP's commitment to doing what is best for children, youth and their families is a core value and one that we look for in our newest team members. 22 Days Off Each Year! Plus 11 Paid Holidays Per Year! Healthcare Benefits for you and your family Pet Insurance Competitive salaries and benefits including a 401(k), Summer Hours Off...

Regulatory Affairs Manager

3 months ago

Lawrenceville, United States High5 Full time

Regulatory & Medical Affairs - Regulatory Studio - CMC Senior Manager

Location: Hybrid (50% onsite) at either Lawrenceville in US or (US 100% Remote)


Job Description:


PREREQUISITES BS/BA degree in Scientific Discipline (Masters or higher preferred) with

5+ years in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience, Sterile Injectable experience preferred.


Responsibilities will include, but are not limited to, the following:


1. Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.

2. Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.

3. May be responsible for the global regulatory evaluation of CMC change controls with supervision.

4. Work with CMC cross-functional teams and Regulatory Affairs teams.

5. Develop and maintain knowledge of regulatory environment, regulations and procedures.



Skills/Knowledge Required:

- Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)

- Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations

- Experience in post-approval requirements

- Experience in developing CMC regulatory strategy

- Experience in project management

- Have a solution-oriented approach to problem solving

- Ability to plan/prioritize work of group members and guide/develop others.

- Ability to work on complex projects and within cross-functional teams with supervision

- Excellent communication skills, both written and oral

- Excellent computer skills