Regulatory Affairs Manager

4 weeks ago


Rockville, United States CareerBuilder Full time

Title: Regulatory Affairs Manager
Location: Remote
Type: Permanent

Salary: 120K 140K plus 10-20% discretionary bonus

Requirements

Bachelor's degree in life sciences or related field; advanced degree preferred.

Minimum of 3-5years of experience in operational regulatory affairs within the biotech, preferably in oncology.

Writing Canadianand US submissions (BGTD experience)

eCTD experience required (package used is off the shelf product)

Strong knowledge of global regulatory requirements and guidelines for drug development.

Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.

Proven ability to manage multiple projects simultaneously and meet tight deadlines.

Detail-oriented with a strategic mindset and problem-solving skills.

Responsibilities

Develop and implement regulatory strategies to support the development and commercialization of oncology products.

Prepare and submit regulatory submissions to health authorities, including INDs, CTAs, NDAs, and marketing applications.

Coordinate and liaise with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.

Keep abreast of regulatory changes and updates relevant to the oncology industry, providing guidance to internal stakeholders.

Represent the company in interactions with regulatory agencies and support regulatory inspections and audits.

Manage regulatory documentation and maintain compliance with applicable regulations and standards.

#J-18808-Ljbffr



  • Rockville, Maryland, United States United States Pharmacopeia Full time

    DescriptionWho is USP?The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of Passion for...


  • Rockville, United States United States Pharmacopeia Full time

    Description Who is USP? The U.S. Pharmacopeial Convention (USP) USP is an independent scientific organization that collaborates with the world's top experts in health and science to develop quality standards for medicines, dietary supplements, and food ingredients. USP's fundamental belief that Equity = Excellence manifests in our core value of...


  • Rockville, United States USAJobs Full time

    DutiesThe successful candidate will perform the full range of public affairs duties.Such duties include but are not limited to: Assist in the administration of stakeholder outreach that contributes to the public understanding of NRC programs and policies related primarily to headquarters and national activities and issues. Coordinates closely with Office...


  • Rockville, Maryland, United States USAJobs Full time

    DutiesThe successful candidate will perform the full range of public affairs duties.Such duties include but are not limited to:Assist in the administration of stakeholder outreach that contributes to the public understanding of NRC programs and policies related primarily to headquarters and national activities and issues. Coordinates closely with Office...


  • Rockville, United States Non-Departmental Agency Full time

    Summary These positions are located in Office of Public Affairs in Rockville, Maryland, Headquarters and in Arlington, Texas, Region IV. The supervisor is Holly Harrington, Acting Office Director.   This position is Bargaining Unit with the National Treasury Employees Union, Chapter...


  • Rockville, Maryland, United States Non-Departmental Agency Full time

    Summary These positions are located in Office of Public Affairs in Rockville, Maryland, Headquarters and in Arlington, Texas, Region IV.The supervisor is Holly Harrington, Acting Office Director. This position is Bargaining Unit with the National Treasury Employees Union, Chapter 208 This position IS not subject to Confidential Financial Disclosure...


  • Rockville, United States Nuclear Regulatory Commission Full time

    Summary Positions are located in the Office of Nuclear Material Safety and Safeguards (NMSS), Division of Materials Safety, Security, State, and Tribal Programs (MSST) Supervisors: Booma Venkataraman , Chris Einberg, and Tim Mossman This positions are Bargaining Unit with the National Treasury Employees Union, Chapter 208  This positions...


  • Rockville, Maryland, United States Department Of Health And Human Services Full time

    Summary The Office of Intergovernmental and Public Affairs serves as the central point for providing leadership and coordination in establishing a collaborative effort between the Substance Abuse and Mental Health Services Administration, other government agencies, and service providers to improve behavioral health outcomes.Duties ABOUT THE POSITIONProvide...

  • Senior Auditor

    1 day ago


    Rockville, United States Financial Industry Regulatory Authority , Inc. Full time

    Conduct audits of business, regulatory, and technology processes of FINRA and its subsidiaries to provide senior management with an independent assessment of whether the internal controls provide reasonable assurance that business objectives are achi Auditor, Internal Auditor, Audit, Senior, Business


  • Rockville, United States finra Full time

    FINRA is dedicated to protecting investors and ensuring the integrity of America's financial system. At FINRA we are focused on employee career development, offering learning opportunities, resources, and tools to help you achieve your professional aspirations. We have an exciting opportunity for a Principal Analyst, MRTS Regulatory Compliance:The...


  • Rockville, United States Financial Industry Regulatory Authority , Inc. Full time

    The Operational Risk Management (ORM) Director plays a key role in the organizations highly visible Enterprise Risk Management (ERM) program efforts to identify, prioritize, monitor, measure, assess, respond and report to senior management and the F Risk, Director, Management, Business Operations, Operations, Operation, Accounting

  • Accountant

    3 days ago


    Rockville, United States Nuclear Regulatory Commission Full time

    The successful candidate will serve as an accountant in the Division of the Comptroller, Financial Services and Operations Branch, performing general accounting duties consistent with the functional responsibilities of the branch within the Division. Responsible for supporting the financial mission of the agency through effective management of financial...


  • Rockville, United States Nuclear Regulatory Commission Full time

    The successful candidate will serve as the principal technologist managing various aspects of the Agency’s IT financial operations (FinOps). This role includes management of enterprise cloud computing financial operations, along with support for other FinOps-related activities including analysis in support of vendor licensing models, hardware/software...

  • Accountant

    6 days ago


    Rockville, Maryland, United States Nuclear Regulatory Commission Full time

    The successful candidate will serve as an accountant in the Division of the Comptroller, Financial Services and Operations Branch, performing general accounting duties consistent with the functional responsibilities of the branch within the Division. Responsible for supporting the financial mission of the agency through effective management of financial...


  • Rockville, Maryland, United States Nuclear Regulatory Commission Full time

    The successful candidate will serve as the principal technologist managing various aspects of the Agency's IT financial operations (FinOps). This role includes management of enterprise cloud computing financial operations, along with support for other FinOps-related activities including analysis in support of vendor licensing models, hardware/software...

  • Materials Engineer

    4 weeks ago


    Rockville, United States Nuclear Regulatory Commission Full time

    Summary This position is located in the Office of Nuclear Material Safety & Safeguards (NMSS), Division of Fuel Management (DFM), Materials & Structural Branch (MSB). The supervisor is Tom Boyce. This position is  Bargaining Unit with the National Treasury Employees Union, Chapter 208. This position IS not subject to Confidential...

  • Medical Officer

    3 weeks ago


    Rockville, United States Kelly Full time

    TASKS(1) Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of Tuberculosis (TB), HIV/AIDS, co-infections, and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems...

  • Medical Officer

    3 weeks ago


    Rockville, United States Kelly Full time

    TASKS(1) Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of Tuberculosis (TB), HIV/AIDS, co-infections, and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems...

  • Medical Officer

    3 weeks ago


    Rockville, United States Kelly Full time

    TASKS(1) Participate in the review, planning and implementation of clinical trials for the treatment and/or prevention of Tuberculosis (TB), HIV/AIDS, co-infections, and/or related co-morbidities. This includes evaluating the hypothesis, objectives, study design, feasibility, and regulatory requirements, as well as identifying medical and logistical problems...


  • Rockville, United States Financial Industry Regulatory Authority Full time

    The Senior Vice PresidentAppellate (SVP) leads and manages the office that supports the National Adjudicatory Council (NAC) in deciding disciplinary cases, membership applications, statutory disqualifications, and exemptive requests. This role also Vice President, President, Senior, Legal