Current jobs related to Regulatory Affairs Manager - Bethesda, Maryland - HR Retail

  • Regulatory Affairs Specialist

    2 weeks ago

    Bethesda, Maryland, United States Beacon Hill Life Sciences - Boston Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Beacon Hill Life Sciences - Boston. As a key member of our team, you will be responsible for preparing and submitting regulatory documents to various authorities, ensuring compliance with relevant regulations and guidelines.Key ResponsibilitiesRegulatory Document...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Bethesda, Maryland, United States HR Retail Full time

    Regulatory Affairs Manager - (MGRRA_HR_RETAIL) Share this job as a link in your status update to LinkedIn. Position Overview The Regulatory Affairs Manager is responsible for overseeing the regulatory team and managing the lifecycle of various drug and biologic submissions. This role ensures adherence to Good Clinical Practices (GCPs), International...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Bethesda, Maryland, United States HR Retail Full time

    Regulatory Affairs Manager - HR RetailPosition OverviewThe Regulatory Affairs Manager will oversee the regulatory team to ensure compliance with industry standards and regulations. This role is crucial in managing the lifecycle of various regulatory submissions and maintaining high-quality standards throughout the process.Key ResponsibilitiesLead the...

  • Senior Regulatory Affairs Specialist

    3 weeks ago

    Bethesda, Maryland, United States HR Retail Full time

    Regulatory Affairs Manager - HR Retail Share this job as a link in your status update to LinkedIn. Position Overview The Regulatory Affairs Manager is responsible for overseeing the regulatory team to ensure the successful management of various drug and biologic submissions, including Investigational New Drug Applications (INDs), Biologics License...

  • Regulatory Affairs Coordinator

    4 weeks ago

    Bethesda, Maryland, United States Technical Resources International Full time

    Regulatory Operations AssociateWe are looking for a meticulous Regulatory Operations Associate to become a part of our committed team at Technical Resources International. If you have a strong interest in regulatory affairs and hold a Bachelor's Degree, this role may be an excellent fit for you.Key Responsibilities:Preparation and organization of...

  • Regulatory Affairs Specialist

    2 weeks ago

    Bethesda, Maryland, United States The Geneva Foundation Full time

    About the PositionThe Regulatory Affairs Coordinator plays a critical role in maintaining regulatory documents related to research, serving as the principal administration regulatory liaison for projects, developing and maintaining recordkeeping systems and procedures, supervising and preparing documents which support research projects, submitting and...

  • Regulatory Affairs Specialist

    6 days ago

    Bethesda, Maryland, United States Technical Resources International Full time

    Job Title: Regulatory SpecialistAt Technical Resources International, we are seeking a highly skilled Regulatory Specialist to join our team.Job SummaryWe are looking for a detail-oriented and organized individual to prepare, distribute, and track regulatory submissions, including INDs, BLAs, NDAs, and IDEs, ensuring compliance with GCPs/ICH and FDA...

  • Regulatory Affairs Operations Specialist

    4 weeks ago

    Bethesda, Maryland, United States Technical Resources International Full time

    Position Title: Regulatory Operations AssociateLocation: Bethesda, MDCategory: Regulatory AffairsJob Type: Full-TimeEducation: Bachelor's DegreeKey Responsibilities:Prepare standard documentation to support regulatory submissions and ensure distribution to relevant stakeholders.Utilize and maintain both physical and electronic filing systems for regulatory...

  • Regulatory Affairs Operations Specialist

    4 weeks ago

    Bethesda, Maryland, United States Technical Resources International Full time

    Position Title: Regulatory Operations AssociateLocation: Bethesda, MDCategory: Regulatory AffairsJob Type: Full-TimeEducation: Bachelor's DegreeTravel: NoneJob Overview:The Regulatory Operations Associate is responsible for preparing standard documentation that supports regulatory submissions and ensures effective distribution to relevant stakeholders.Key...

  • Regulatory Compliance Manager

    3 weeks ago

    Bethesda, Maryland, United States HR Retail Full time

    Regulatory Affairs Manager - (MGRRA_HR_RETAIL) Share this job as a link in your status update to LinkedIn. Position OverviewThe Regulatory Affairs Manager will oversee the regulatory team responsible for managing the lifecycle of various drug and biologic applications, ensuring adherence to all relevant regulations and...

  • Regulatory Compliance Manager

    3 weeks ago

    Bethesda, Maryland, United States HR Retail Full time

    Regulatory Affairs Manager - (MGRRA_HR_RETAIL) Share this job as a link in your status update to LinkedIn. Position Overview The Regulatory Affairs Manager is responsible for overseeing the regulatory team to ensure the successful management of various drug and biologic applications, including Investigational New Drug Applications (INDs), Biologics License...

  • Regulatory Compliance Manager

    4 weeks ago

    Bethesda, Maryland, United States HR Retail Full time

    Regulatory Affairs Manager - (MGRRA_HR_RETAIL) Share this job as a link in your status update to LinkedIn. Position OverviewThe Regulatory Affairs Manager is responsible for overseeing the regulatory team to ensure the effective management of various drug and biologic applications. This role is critical in maintaining compliance with Good Clinical Practices...

  • Senior Manager of Regulatory Affairs

    2 weeks ago

    Bethesda, Maryland, United States Moderna Therapeutics Full time

    About the RoleModerna Therapeutics is seeking a highly skilled Regulatory Strategy Manager to join our team in Cambridge, Massachusetts. As a key member of our Clinical Development team, you will play a critical role in shaping our regulatory strategy and ensuring compliance with relevant regulations.Key ResponsibilitiesDevelop and implement regulatory...

  • Regulatory Strategy Director

    3 weeks ago

    Bethesda, Maryland, United States Moderna Full time

    About the RoleModerna is seeking a seasoned Regulatory Strategy Director to join our Global Regulatory Strategy, Infectious Diseases team. As a key member of our team, you will be responsible for developing and executing regulatory plans for our COVID-19 franchise programs in the US market.Key ResponsibilitiesStrategic Leadership: Collaborate with global...

  • Regulatory Strategy Director

    3 weeks ago

    Bethesda, Maryland, United States Moderna Full time

    About the RoleModerna, Inc. is seeking a seasoned professional to lead Regulatory Strategy for the COVID-19 franchise. This role requires a forward-thinking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for and licensure maintenance of messenger RNA COVID-19 vaccines.Key...

  • Regulatory Strategy Director

    3 weeks ago

    Bethesda, Maryland, United States Moderna Full time

    About the RoleModerna, Inc. is seeking a seasoned professional to lead Regulatory Strategy for the COVID-19 franchise. This role requires a forward-thinking, creative regulatory strategist able to anticipate and address the challenges involved in gaining market approval for and licensure maintenance of messenger RNA COVID-19 vaccines.Key...

  • Regulatory Health Expert

    5 days ago

    Bethesda, Maryland, United States Booz Allen Hamilton Full time

    Job SummaryWe are seeking a highly skilled Regulatory Health Consultant to join our team at Booz Allen Hamilton. As a key member of our regulatory health portfolio, you will support projects related to medical device and drug regulation, organizational excellence, strategic planning, regulatory science, program evaluation, and project management.Key...

  • Regulatory Health Expert

    3 weeks ago

    Bethesda, Maryland, United States Booz Allen Hamilton Full time

    Job SummaryWe are seeking a highly skilled Regulatory Health Consultant to join our team at Booz Allen Hamilton. As a Regulatory Health Consultant, you will play a critical role in supporting the regulatory health portfolio on projects, including medical device and drug regulation, organizational excellence, strategic planning, regulatory science, program...

  • Regulatory Strategy Director

    3 weeks ago

    Bethesda, Maryland, United States Moderna Full time

    About the RoleModerna is seeking a seasoned Regulatory Strategy Director to join our Global Regulatory Strategy, Infectious Diseases team. As a key member of our team, you will be responsible for developing and executing regulatory plans for our COVID-19 franchise programs in the US market.Key ResponsibilitiesStrategic Leadership: Collaborate with global...

  • Regulatory Health Expert

    4 days ago

    Bethesda, Maryland, United States Booz Allen Hamilton Full time

    Regulatory Health ConsultantSupport the regulatory health portfolio on projects, including medical device and drug regulation, organizational excellence, strategic planning, regulatory science, program evaluation, and project management. Apply problem-solving in health or life-science background to develop solutions to operational and strategic challenges...

Regulatory Affairs Manager

3 months ago

Bethesda, Maryland, United States HR Retail Full time
Regulatory Affairs Manager - (MGRRA_COMPANY_1)

Share this job as a link in your status update to LinkedIn.

Job Title

Regulatory Affairs Manager

Location

Bethesda, MD 20817 US (Primary)

Category

Regulatory Affairs

Job Type

Full-Time

Education

Bachelor's Degree

Travel

None

Job Description

  • Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
  • Coordinates the tracking, compiling, and reviewing of regulatory submissions including, but not limited to New INDs, BLA, NDS, IDEs, Annual Reports to INDs and Protocol Reviews for accuracy, completeness and quality.
  • Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
  • Supervises and manage Regulatory Team staff members, as assigned.
  • Leads and participates in projects as assigned to optimize regulatory processes and facilitate best practice approaches to drive functional excellence.
  • Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.
  • Coordinates the maintenance of work process tools to promote efficiency and productivity.? These may include templates, SOPs, work instructions, checklists, trackers, etc.
  • Performs literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
  • Provides regulatory and project management support for projects as needed.
  • Coordinates across projects as needed to ensure harmonization and knowledge sharing.
  • Provides oversight for the tracking of regulatory activity, database maintenance, and ensure that records are complete, accurate, and current.
  • Supports the preparation and review of technical proposals.
Job Requirements
  • Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
  • Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
  • Superior organizational skills and customer service abilities.
  • Ability to analyze medical research data and review experimental protocols.
  • Strong working knowledge of Microsoft office; experience with SharePoint a plus.
  • Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus.
  • Experience in preparing regulatory documents, publishing regulatory submissions using?electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
  • Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.?
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.
#J-18808-Ljbffr