Regulatory Affairs Specialist
4 days ago
Merz 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 strategy and promotional programs. The ideal candidate will have a strong understanding of regulatory requirements and guidelines, as well as experience in leading activities for promotional OPDP submissions.
Key Responsibilities:- Manage US and Canada commercial activities from a regulatory advertising and promotion perspective
- Provide timely regulatory advice and guidance to US and Canadian Commercial team leads and Medical Affairs with respect to promotional (PRC) and Medical Affairs (SRC) materials
- Creatively advise on the development of product messages and materials across multiple functional areas successful campaigns and new product/indication launches
- Responsible for all FDA OPDP submissions on form 2253 which may include submissions for advisory comment
- Lead regulatory training of HCP speakers, and key product endorsers, which may include celebrities
- Ensure that changes in Prescribing Information are reflected in promotional and advertising materials
- Prepare and update Important Safety Information for products as needed with new labeling changes as well as variances needed for use in different media
- Coordinate and implement training of Merz employees on regulatory issues pertaining to promotion of company products
- Periodically required to work after normal working hours for on-demand promotional material approvals for pivotal commercial initiatives
- BA, BS or advanced degree with an emphasis in science, health care or related fields
- 5 years of experience in the regulatory field with at least 2 years of experience in review and approval of professional and consumer prescription pharmaceutical advertising and promotion
- Experience in leading activities for promotional OPDP submissions (including Form 2253 submissions)
- Preferred Qualifications: Experience in both medical device and pharmaceutical advertising and promotion is desirable
Merz North America offers a competitive salary range of $120k to $140k (Annual Bonus 20%) and a dynamic work environment.
We are an Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities.
-
Regulatory Affairs Director
4 weeks ago
Raleigh, North Carolina, United States Proclinical Staffing Full timeJob 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 timeRegulatory 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 timeRegulatory 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
2 weeks ago
Raleigh, North Carolina, United States Proclinical Staffing Full timeJob 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
2 weeks ago
Raleigh, North Carolina, United States Proclinical Staffing Full timeRegulatory 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 Director
3 weeks ago
Raleigh, North Carolina, United States Proclinical Staffing Full timeRegulatory 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 Specialist
2 weeks ago
Raleigh, North Carolina, United States Merz Pharmaceuticals LLC Full timeJob 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 Specialist
4 days ago
Raleigh, North Carolina, United States Novozymes North America Full timeRegulatory Affairs ManagerNovozymes 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 ResponsibilitiesProvide regulatory guidance throughout the...
-
Regulatory Affairs Labeling Manager
3 weeks ago
Raleigh, North Carolina, United States Proclinical Staffing Full timeJob 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 timeJob 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 timeAbout 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 timeAbout 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 timeAbout 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 timeAbout 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 timeAbout 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 timeJob 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 timeJob 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 timeJob 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 timeJob 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 Manager
3 weeks ago
Raleigh, North Carolina, United States WakeMed Full timeAbout WakeMed:WakeMed Health & Hospitals is a leading provider of health services in Wake County, serving the community since 1961. Our mission is to improve the health and well-being of our community by providing outstanding and compassionate care.Job Summary:The Core Laboratory Pathology Manager is responsible for the successful operation of the...