Regulatory Affairs Specialist

4 days ago

Raleigh, North Carolina, United States Novozymes North America Full time
Regulatory Affairs Manager

Novozymes North America seeks an experienced Regulatory Affairs professional to join our US Plant Biosolutions Regulatory Team with primary responsibility in the biopesticide area that includes microorganisms, enzymes, and other novel microbial-derived technologies.

Key Responsibilities
  • Provide regulatory guidance throughout the product life cycle, from early assessment through post-launch activities.
  • Align with global regulatory and across global functions on data requirements to ensure high-quality dossiers.
  • Develop and implement strategies for product submissions, prepare regulatory pre-submission documents, and lead submission meetings.
  • Responsible for the regulatory submission to regulatory agencies and ensuring timely approval.
  • Stay up-to-date with current and potential changes in regulatory standards and/or requirements in the country of responsibility and communicate them to relevant internal Regulatory colleagues and key stakeholders.
  • Serve as a subject matter expert on agricultural regulations and coordinate regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
  • Organize and conduct training sessions to enhance the organization's knowledge of working in a regulated environment.
Qualifications
  • BS/MS in the Life Sciences (Microbiology, Molecular Biology, Biochemistry) required with a minimum of 9-11 years of relevant Regulatory and registration work experience.
  • Experience/knowledge in Regulatory working with the application and scientific and technical aspects of microbial technologies used for bio-agricultural applications.
  • Current experience working within Regulatory Authorities such as US EPA, USDA, FDA, US state ag departments, and related Trade Associations and other industry groups.
  • Strong experience in working effectively with external partners and in successfully handling highly confidential information.
  • Proven aptitude with a variety of computer disciplines (Microsoft, Veeva).
  • Good interpersonal skills and interest in working and interacting with diverse cultures.
  • Strong project management, organizational, written/oral communication skills.
  • Ability to effectively manage multiple projects simultaneously in a team-oriented environment.
  • Travel 10-15% within North America as well as international travel with periodic trips to Copenhagen Denmark required.
  • The position is ideally located in the greater Raleigh, NC area; however, other locations may be considered as long as ability to travel to the Raleigh, NC area once per quarter.
  • Ability to work in the U.S. without sponsorship.

  • Regulatory Affairs Director

    4 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Job Title: Regulatory Affairs DirectorProclinical Staffing is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our Commercial team, you will be responsible for providing regulatory leadership and guidance to ensure compliance with FDA regulations and industry guidelines.Key Responsibilities:Provide regulatory input...

  • Regulatory Affairs Manager

    4 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Regulatory Affairs Labeling ManagerProclinical Staffing is seeking a skilled Regulatory Affairs Labeling Manager to join a global biopharmaceutical company with locations in the US.Key Responsibilities:The successful candidate will lead the development of new labeling content in collaboration with cross-functional project teams. They will manage the creation...

  • Regulatory Affairs Manager

    4 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Regulatory Affairs Labeling ManagerProclinical Staffing is seeking a skilled Regulatory Affairs Labeling Manager to join a global biopharmaceutical company with locations in the US.Key Responsibilities:The successful candidate will lead the development of new labeling content in collaboration with cross-functional project teams. They will manage the creation...

  • Regulatory Affairs Specialist

    4 days ago

    Raleigh, North Carolina, United States Merz North America Full time

    Job Title: Regulatory Affairs AdvertisingMerz North America is seeking a highly skilled Regulatory Affairs Advertising professional to join our team.Job Summary:We are looking for a Regulatory Affairs Advertising professional to provide strategic input on regulatory policy and standards and requirements in the development and implementation of marketing...

  • Regulatory Affairs Manager

    2 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Job Title: Manager, Regulatory Affairs LabelingProclinical is seeking a skilled Manager, Regulatory Affairs Labeling to join a global biopharmaceutical company with locations in Georgia, North Carolina, and Massachusetts.Job Summary:The Manager, Regulatory Affairs Labeling will lead the development of new labeling content in collaboration with a...

  • Regulatory Affairs Director

    3 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Regulatory Affairs Director - US Advertising and PromotionProclinical Staffing is seeking a highly skilled Regulatory Affairs Director to lead our client's US advertising and promotion efforts. As a key member of the team, you will be responsible for ensuring compliance with FDA regulations and industry guidelines.Key Responsibilities:Provide regulatory...

  • Regulatory Affairs Director

    2 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Regulatory Affairs Director - US Advertising and PromotionProclinical Staffing is seeking a highly skilled Regulatory Affairs Director to lead our client's US advertising and promotion efforts.Key Responsibilities:Provide regulatory leadership and guidance to Commercial teams during the development, review, and approval of product labeling and advertising...

  • Regulatory Affairs Specialist

    2 weeks ago

    Raleigh, North Carolina, United States Merz Pharmaceuticals LLC Full time

    Job Title: Regulatory Affairs AdvertisingAt Merz Pharmaceuticals LLC, we are seeking a highly skilled Regulatory Affairs Advertising professional to join our team.Key Responsibilities:Provide strategic input on regulatory policy and standards to ensure compliance with marketing strategy and promotional programs.Lead collaborative discussions with the...

  • Regulatory Affairs Labeling Manager

    3 weeks ago

    Raleigh, North Carolina, United States Proclinical Staffing Full time

    Job Title: Manager, Regulatory Affairs LabelingProclinical Staffing is seeking a skilled Manager, Regulatory Affairs Labeling to join our team.Job Summary:We are looking for a highly experienced professional to lead the development of new labeling content in collaboration with a cross-functional project team. The successful candidate will manage the creation...

  • Senior Director Global Regulatory Affairs

    2 weeks ago

    Raleigh, North Carolina, United States Danaher Corporation Full time

    Job Title: Senior Director Global Regulatory AffairsAt Danaher Corporation, we are committed to accelerating the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.About the Role:We are seeking a...

  • Legislative Affairs Specialist

    3 weeks ago

    Raleigh, North Carolina, United States JTI Inc Full time

    About the RoleWe are seeking a highly skilled Legislative Affairs Manager to join our dynamic team at JTI USA. As a key member of our Corporate Affairs and Communications function, you will play a critical role in monitoring and tracking legislative and regulatory proposals that impact our business.Your primary responsibility will be to analyze and assess...

  • Legislative Affairs Specialist

    3 weeks ago

    Raleigh, North Carolina, United States JTI Inc Full time

    About the RoleWe are seeking a highly skilled Legislative Affairs Manager to join our dynamic team at JTI USA. As a key member of our Corporate Affairs and Communications function, you will play a critical role in monitoring and tracking legislative and regulatory proposals that impact our business.Your primary responsibility will be to analyze and assess...

  • Legislative Affairs Specialist

    3 weeks ago

    Raleigh, North Carolina, United States JTI Inc Full time

    About the RoleWe are seeking a highly skilled Legislative Affairs Manager to join our dynamic team at JTI USA. As a key member of our Corporate Affairs and Communications function, you will play a critical role in monitoring and tracking legislative and regulatory proposals that impact our business operations.Your primary responsibilities will...

  • Legislative Affairs Specialist

    4 weeks ago

    Raleigh, North Carolina, United States JTI Inc Full time

    About the RoleWe are seeking a highly skilled Legislative Affairs Manager to join our dynamic team at JTI USA. As a key member of our Corporate Affairs and Communications function, you will play a critical role in monitoring and tracking legislative and regulatory proposals that impact our business operations.Your primary responsibilities will...

  • Federal Regulatory Specialist

    4 weeks ago

    Raleigh, North Carolina, United States ADAMA Ltd. Full time

    About the RoleWe are seeking a highly skilled Federal Regulatory Manager to join our team at ADAMA Ltd. This role will be responsible for ensuring our products meet required legislation and regulations.Key ResponsibilitiesDevelop and implement regulatory strategies for designated active ingredients and products.Process submissions according to agreed project...

  • Intergovernmental Affairs Specialist

    3 weeks ago

    Raleigh, North Carolina, United States City of Raleigh North Carolina Full time

    Job SummaryThe City of Raleigh is seeking a highly skilled Intergovernmental and External Affairs Manager to support the development and implementation of strategic partnerships and initiatives.Key ResponsibilitiesDevelop and maintain relationships with local, state, and federal government agencies, as well as community organizations and stakeholders.Provide...

  • Intergovernmental Affairs Specialist

    3 weeks ago

    Raleigh, North Carolina, United States City of Raleigh, NC Full time

    Job SummaryWe are seeking a highly skilled Intergovernmental and External Affairs Manager to join our team at the City of Raleigh, NC. This is a unique opportunity to work with a dynamic organization and contribute to the development of our city's policy and legislative agenda.Key ResponsibilitiesSupport the development and implementation of goals,...

  • Intergovernmental Affairs Specialist

    2 weeks ago

    Raleigh, North Carolina, United States City of Raleigh, NC Full time

    Job SummaryThe City of Raleigh, NC is seeking a highly skilled Intergovernmental and External Affairs Manager to support the City's policy interests and build community partnerships and intergovernmental relationships at all levels.Key ResponsibilitiesSupport Intergovernmental Relations activities and services, including assisting in the development and...

  • Vice President of Student Affairs

    2 weeks ago

    Raleigh, North Carolina, United States Shaw University Full time

    Job SummaryThe Vice President for Student Affairs at Shaw University provides strategic leadership and oversight for all student-related services and programs. Reporting to the President, this key executive is responsible for ensuring a positive and inclusive campus environment that supports student success and well-being.Key ResponsibilitiesDevelop and...

  • Pathology Laboratory Manager

    4 weeks ago

    Raleigh, North Carolina, United States WakeMed Full time

    About WakeMedWakeMed Health & Hospitals is a leading provider of health services in Wake County, committed to improving the health and well-being of our community. With a rich history dating back to 1961, we strive to deliver outstanding and compassionate care.Job SummaryThe Core Laboratory Pathology Manager is responsible for the successful operation of the...