Regulatory Affairs Specialist

hace 4 semanas


Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

Regulatory Affairs Officer

We are seeking a Regulatory Affairs Officer to manage post-MAA activities (Life Cycle Management) for the Canadian market. This role involves coordinating and performing regulatory steps until closure of change controls, compiling regulatory dossiers, and documenting and tracking regulatory submissions.

Responsibilities

  • Manage post-approval activities (Life Cycle Management) for the Canadian market.
  • Initiate change controls, including regulatory assessment of the change in accordance with Health Canada guidances.
  • Coordinate and perform subsequent regulatory steps until closure of the change control.
  • Compile regulatory dossiers in accordance with national requirements.
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services.

Requirements

  • Bachelor's degree or more in a Life Sciences related field. Pharmacy degree would be a plus.
  • At least 2 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider.

Skills

  • Experience in regulatory lifecycle maintenance activities for drug products (Renewals, Change Controls, PI updates, technical variations) in Canada (to Health Canada).
  • Knowledge of the Canadian (CA) regulations for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products.
  • Knowledge of CMC documents (Module 3) on the Canadian market.
  • Experience with change controls on the Canadian market.
  • Fluent English is mandatory, French would be a great plus.
  • Excellent organizational and interpersonal skills.
  • Excellent communication skills.
  • Ability to work well within a team and autonomously.
  • Ability to prioritize different workloads/multi-task.
  • Ability to deliver on tight timelines.
  • Process orientated with good attention to detail.
  • Solution driven.


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at ProductLife Group. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval activities for the Canadian market, including life cycle management, change controls, and regulatory submissions.Key Responsibilities:Manage...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    In this role as a Regulatory Affairs Specialist, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions. You will partner with our Regulatory Affairs leads, in providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    We are seeking a Regulatory Affairs Specialist to contribute to ensuring the delivery of regulatory activities on a global level.Key Responsibilities:To assist in the production of client administrative documents for regulatory submissions.To compile regulatory dossiers in accordance with national requirements and ensure their accuracy.To manage systems and...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Job DescriptionWe are seeking a highly skilled Global Regulatory Affairs Specialist to ensure the delivery of regulatory activities on a global level. This role requires strong organizational and interpersonal skills, with excellent oral and written communication abilities.


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    We are seeking a Regulatory Affairs Specialist to ensure the delivery of regulatory activities on a global level.Key ResponsibilitiesContribute to the production of client administrative documents for regulatory submissions.Compile regulatory dossiers in accordance with national requirements.Manage systems and administer regulatory processes.Track and...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    In the context of a new project, we are seeking a Regulatory Affairs Specialist to support our teams in Mexico/LATAM.Key ResponsibilitiesProvide guidance and support on Mexican and Central America legislation.Contribute to regulatory activities, including pre-licensing, new registrations, and post-licensing submissions.Assist in the production of client...


  • Ciudad de México, Ciudad de México Solventum A tiempo completo

    Job Description:Regulatory Affairs Specialist, Mexico (Solventum)Solventum is a company committed to innovation and excellence in the healthcare sector. We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico.Key Responsibilities:Provide regulatory support for medical products sold in Mexico, including managing licenses with...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Position for Novo Nordisk GBS MexicoPursue a challenging career in regulatory affairs with Novo Nordisk's Global Business Service Centre in Mexico City.We are seeking a highly skilled Regulatory Affairs Coordinator to support the compilation, submission, and approval of Country Specific Submissions files for responsible countries.Key ResponsibilitiesSupport...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    Job TitleRegulatory Affairs Specialist in CanadaAbout UsProductLife Group is a leading provider of regulatory services for the pharmaceutical industry.Job DescriptionWe are seeking an experienced Regulatory Affairs Specialist to join our team in Mexico or Canada. As a Regulatory Affairs Specialist, you will be responsible for managing post-approval...


  • Ciudad de México, Ciudad de México Solventum A tiempo completo

    Job OverviewSolventum is seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico. As a Regulatory Affairs Specialist, you will be responsible for providing general regulatory support for medical products sold in Mexico, including managing medical product licenses with COFEPRIS, reviewing and approving product labeling and...


  • Ciudad de México, Ciudad de México Solventum A tiempo completo

    Improve Healthcare with SolventumSolventum is a company dedicated to enhancing healthcare by pioneering game-changing innovations at the intersection of health, material, and data science. As a Regulatory Affairs Specialist, you will be part of our team that ensures every solution created for our customers' toughest challenges adheres to the highest...


  • Ciudad de México, Ciudad de México Icon Plc A tiempo completo

    The Regulatory Affairs Specialist will contribute to the preparation, compilation, and submission of regulatory documents, including CT/IND, MAA, and NOA. Key Responsibilities:- Regulatory Document Preparation: Prepare and submit regulatory documents in a timely and accurate manner.- Collaboration with Teams: Work with the Regulatory Submissions team and...


  • Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo

    In a pivotal role at Thermo Fisher Scientific, the Sr Regulatory Affairs Specialist will be part of our Regulatory Liaison team, spearheading communications with regulatory agencies as part of centralized regulatory submissions. This includes collaboration with regulatory affairs leads to provide strategic guidance and technical/project leadership on a...


  • Ciudad de México, Ciudad de México Mccormick & Company A tiempo completo

    **Scientific and Regulatory Affairs Manager LATAM**Mccormick & Company, a world leader in the spice, flavor and seasonings industry, is seeking a full time Scientific and Regulatory Affairs Manager LATAM. This new hire will work in our Mexico City location.We create differentiating flavors consumers prefer with unmatched quality, science, innovation and...


  • Ecatepec de Morelos, México Philips A tiempo completo

    **Job Title**: Regulatory Affairs SpecialistAt Philips, we're committed to improving billions of lives worldwide through innovation. As a Regulatory Affairs Specialist, you'll play a crucial role in ensuring our medical and non-medical products meet regulatory requirements in Mexico and Latin America.**Key Responsibilities:**Communicate Mexico-specific...


  • Ciudad de México, Ciudad de México Qiagen A tiempo completo

    Regulatory Affairs Manager RoleWe are seeking an experienced Regulatory Affairs Manager to lead and undertake regulatory responsibility for Mexico and Central Americas to ensure our IVD products comply with regional regulations and laws.This role involves developing and implementing regulatory strategies to facilitate product approvals, registrations, and...


  • Ciudad de México, Ciudad de México Novo Nordisk AS A tiempo completo

    Position OverviewWe are seeking a Regulatory Affairs Coordinator to join our team in GBS Mexico City. As a key member of our Global Business Service team, you will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files.About the RoleAs a Regulatory Affairs Coordinator at Novo Nordisk A/S, your main...


  • Ciudad de México, Ciudad de México ICON Plc A tiempo completo

    Regulatory Affairs Specialist with Expertise in Clinical TrialsAt ICON Plc, we're seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs team, you will be responsible for leading the preparation, submission, and maintenance of regulatory documents for clinical trials. Your expertise in clinical...


  • Ciudad de México, Ciudad de México Ortho Clinical Diagnostics A tiempo completo

    The OpportunityAt Ortho Clinical Diagnostics, we are committed to delivering innovative solutions that transform the power of diagnostics into a healthier future for all. We are seeking a highly skilled Regulatory Affairs Associate to join our team and contribute to our mission.Key ResponsibilitiesPrepare and submit regulatory documents, including technical...


  • Ciudad de México, Ciudad de México ProductLife Group A tiempo completo

    In the pharmaceutical industry, compliance with regulations is critical for the success of any project. As a Regulatory Affairs Specialist, you will play a key role in ensuring that our company, ProductLife Group, meets all regulatory requirements in Mexico and Central America.Responsibilities:Provide guidance and support on Mexican and Central America...