Regulatory Affairs Specialist

2 months ago


Canada Organon LLC Full time

Regulatory Affairs Specialist

**Job Summary**

Organon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects.

**Key Responsibilities**

* Lead the preparation and submission of CMC dossiers for assigned Network Projects
* Collaborate with CMC Product Leaders, OMS Network Teams, and CMC partners to ensure progress towards project goals
* Provide CMC support to the Network Project CMC Lead for making strategy for projects
* Work with outsourced support of Network activities in alignment with the OMS CMC outsource strategy
* Proactively collaborate with external partners to monitor, report, and act on delivery performance and quality of deliverables

**Requirements**

* Bachelor's degree in a science, engineering, or a related field
* Minimum 7 years of relevant experience in biological/pharmaceutical research, manufacturing, testing, or a related field
* Strong negotiation, interpersonal, written/oral communication, and fluent in English language
* Project Management
* Good understanding of change management projects
* Direct experience in Regulatory CMC
* Demonstrated experience driving change initiative projects

**About Organon LLC**

Organon LLC is a 5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions.



  • Canada Organon LLC Full time

    Job SummaryOrganon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network Projects.Provide regulatory CMC...


  • Canada Organon LLC Full time

    Job SummaryOrganon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network Projects.Provide regulatory CMC...


  • Canada Organon LLC Full time

    Organon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects. Your expertise will be crucial in leading the preparation and submission of CMC dossiers for assigned...


  • Canada Organon LLC Full time

    Organon LLC is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Chemistry, Manufacturing & Controls (CMC) department, you will be responsible for providing regulatory CMC support for our Network Projects. Your expertise will be crucial in leading the preparation and submission of CMC dossiers for assigned...


  • Canada Organon LLC Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for...


  • Canada Organon LLC Full time

    Job SummaryWe are seeking a highly skilled and experienced Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for...


  • Canada Organon LLC Full time

    Job SummaryWe are seeking a highly skilled Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network...


  • Canada Organon LLC Full time

    Job SummaryWe are seeking a highly skilled Associate Principal Scientist, Regulatory Affairs to join our team at Organon LLC. As a key member of our Regulatory Affairs department, you will be responsible for providing regulatory CMC support for our Network Projects.Key ResponsibilitiesLead the preparation and submission of CMC dossiers for assigned Network...


  • Canada Organon LLC Full time

    Job Title: Associate Principal Scientist, Regulatory AffairsThe Associate Director (Associate Principal Scientist), Organon Manufacturing & Supply (OMS), Chemistry, Manufacturing & Controls (CMC), Network Project & Resource Management will provide strategic CMC support for Organon Network Projects. This position will lead the preparation and submission of...


  • Canada Bluebayinvest Full time

    Job SummaryBluebayinvest is seeking a highly skilled Senior Manager, Regulatory Affairs to join our team. As a key member of our IT Risk Management function, you will play a critical role in protecting our brand, systems, and operations by equipping business and technology partners with meaningful insights, advice, and information on RBC IT & cyber risks.Key...


  • Canada, CA MY01 Full time

    *La version française suitFounded in 2019 and based in Montreal, MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. Specializing in managing limb ischemia and compartment syndrome, our tools provide proactive monitoring and actionable insights through a connected care team that benefits...


  • Canada, CA MY01 Full time

    *La version française suitFounded in 2019 and based in Montreal, MY01 envisions a world where every disease is quantifiable, enabling precise, personalized care for all patients. Specializing in managing limb ischemia and compartment syndrome, our tools provide proactive monitoring and actionable insights through a connected care team that benefits...


  • Canada Canadian Hispanic Bar Association Full time

    Job SummaryThe Canadian Hispanic Bar Association is seeking a highly skilled and experienced Senior Securities Lawyer to join our team. As a key member of our Registration Team, you will play a critical role in providing advice and recommendations on the securities registration regime in Canada.Key ResponsibilitiesAdvise on the registration regime in Canada...


  • Canada Canadian Hispanic Bar Association Full time

    {"Job Title": "Legal Counsel", "Job Description": "Job SummaryWe are seeking a highly skilled Legal Counsel to join our Registration Team at the Ontario Securities Commission. As a key member of our team, you will provide advice and recommendations on the securities registration regime in Canada, including novel matters.The ideal candidate will have a strong...


  • Canada Canadian Hispanic Bar Association Full time

    Job SummaryThe Canadian Hispanic Bar Association is seeking a highly skilled and experienced Senior Securities Lawyer to join our team. As a key member of our Registration Team, you will play a critical role in providing advice and recommendations on the securities registration regime in Canada.Key ResponsibilitiesAdvise on the registration regime in Canada...


  • Canada Canadian Hispanic Bar Association Full time

    {"Job Title": "Legal Counsel", "Job Description": "Job SummaryWe are seeking a highly skilled Legal Counsel to join our Registration Team at the Ontario Securities Commission. As a key member of our team, you will provide advice and recommendations on the securities registration regime in Canada, including novel matters.The ideal candidate will have a strong...


  • Canada CKOC 1150 Radio Inc Full time

    Job Title: Manager, Regulatory ConsultingAbout the Role:We are seeking a highly skilled and experienced Manager, Regulatory Consulting to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and support to our clients in the development and implementation of regulatory strategies.Key...


  • Canada CKOC 1150 Radio Inc Full time

    Job Title: Manager, Regulatory ConsultingAbout the Role:We are seeking a highly skilled and experienced Manager, Regulatory Consulting to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic guidance and support to our clients in the development and implementation of regulatory strategies.Key...


  • Canada Organon LLC Full time

    Job Title: Associate Director, Regulatory CMCOrganon LLC is seeking an experienced Associate Director, Regulatory CMC to provide regulatory support for our Network Projects. The successful candidate will lead the preparation and submission of CMC dossiers for assigned projects, working closely with CMC Product Leaders, OMS Network Teams, and CMC partners.Key...


  • Canada Organon LLC Full time

    Job Title: Associate Director, Regulatory CMCOrganon LLC is seeking an experienced Associate Director, Regulatory CMC to provide regulatory support for our Network Projects. The successful candidate will lead the preparation and submission of CMC dossiers for assigned projects, working closely with CMC Product Leaders, OMS Network Teams, and CMC partners.Key...