Regulatory Affairs Expert with Strategic Intelligence

hace 2 días

Ciudad de México, Ciudad de México Thermo Fisher Scientific A tiempo completo
Job Description:

Senior Regulatory Affairs Specialist

The Thermo Fisher Scientific team is seeking a highly organized and experienced Senior Regulatory Affairs Specialist to lead the development of innovative regulatory solutions and provide expertise to support product development from preclinical stages through registration and product optimization.

This role involves strategic intelligence and guidance, ensuring that client deliverables meet current local, regional, and ICH regulatory and technical requirements. The ideal candidate will act as a liaison with internal and external clients and oversee the preparation and submission of regulatory documentation.

Key Responsibilities:

  • Support the preparation of documentation and submissions under guidance.
  • Coordinate and manage client deliverables ensuring regulatory compliance.
  • Liaise with internal and external clients to track and update the status of long-range planning, adapting to changing priorities and handling multiple projects.
  • Exhibit good negotiation skills and the capability to work independently with direction, exercising independent judgment.
  • Independently assess sponsor regulatory needs and collaborate with project team members to produce compliant deliverables.
  • Possess basic knowledge of global/regional/national country requirements and regulatory affairs procedures for clinical trial authorization, licensing, and lifecycle management.
  • Understand medical terminology, statistical concepts, and guidelines.
  • Demonstrate good analytical, investigative, and problem-solving skills, with the ability to interpret data.

New Tasks and Responsibilities:

  • Accountable and responsible for overseeing all submission types to Regulatory Authorities and/or EC/other local submissions, including North America IRB submissions.
  • Manage country-specific local applications, overseeing the entire process from preparation to approval.
  • Collect regulatory requirements and coordinate country-specific local applications, relying on RegView entries and follow-ups with CASs.
  • Ensure adherence to standard RAL procedures applicable to EC and RA submissions.
  • Oversee the development, translation, and filing of country and site-specific submission-related documents for RA, US IRBs, and Canadian ECs submissions.
  • Ensure that submission-related documents are received within the agreed timeline and filed according to agreed processes.
  • Inform all Lead RAL and/or functional leads of the required deadlines for submission document availability.
  • Liaise with Lead RAL and/or responsible functional leads in the CRG internal team to ensure documents required for submission are ready in time as per the submission plan.

Working Conditions and Environment:

  • Work is performed in an office environment with exposure to electrical office equipment.
  • Occasional drives to site locations with occasional travel, both domestic and international.

Physical Requirements:

  • Coordinate all North America IRB activities and ensure that essential document quality meets the expectations of Regulatory Compliance Review.
  • Ensure timely North America regulatory and/or IRB submissions and follow up on all questions raised by ethics committees.

Management Role:

  • No management responsibility.

This role requires a highly organized individual with strong regulatory expertise and the ability to manage multiple projects and adapt to changing priorities. The successful candidate will possess excellent communication and negotiation skills, along with a basic understanding of the regulatory landscape and procedures.

Compensation: The estimated salary for this position is $95,000 - $115,000 per year, based on experience and qualifications.

Requirements:

  • Bachelor's degree or equivalent and relevant formal academic/vocational qualification.
  • Previous experience that provides the knowledge, skills, and abilities to perform the job comparable to 5+ years.

Knowledge, Skills, and Abilities:

  • Good English language (written and oral) communication skills as well as local language where applicable.
  • Good attention to detail and quality as well as editorial/proofreading skills.
  • Good interpersonal skills to work effectively in a team environment.
  • Good computer skills including the use of Microsoft Word, Excel, PowerPoint; capable of learning new technologies.
  • Basic organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities, and handle multiple projects.
  • Good negotiation skills.
  • Capable of working independently with direction and exercising independent judgment.
  • Capable of independently assessing sponsor regulatory needs and working with project team members in producing compliant deliverables.
  • Basic knowledge of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management.
  • Basic understanding of medical terminology, statistical concepts, and guidelines.
  • Good analytical, investigative, and problem-solving skills.

  • Regulatory Affairs Strategic Lead

    hace 1 mes

    Ciudad de México, Ciudad de México Gilead Sciences Mexico, S. de R.L. de C.V. A tiempo completo

    At Gilead Sciences Mexico, S. de R.L. de C.V., we are seeking a seasoned Regulatory Affairs professional to join our team as a Regulatory Affairs Strategic Lead.About the RoleThis is an exciting opportunity for a highly skilled and experienced individual to play a key role in shaping our regulatory strategies and ensuring compliance with applicable...

  • Regulatory Affairs Director

    hace 6 días

    Ciudad de México, Ciudad de México Novartis Farmacéutica A tiempo completo

    About the Role\As a Regulatory Affairs Leader at Novartis Farmacéutica, you will play a crucial role in ensuring compliance with regulatory requirements and maintaining the technical documentation change system.\The ideal candidate will have experience managing global regulatory submission projects, providing strategic input on regulatory strategy,...

  • Regulatory Affairs Expert

    hace 1 mes

    Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Expert to join our team at Worldwide Clinical Trials.Job DescriptionIn this role, you will be responsible for planning, initiating and tracking documents required for regulatory submissions. You will also be involved in collecting essential documents, reviewing country/site/EC requirements, and...

  • Regulatory Affairs Expert

    hace 1 semana

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

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to lead our North American team. As a key member of our regulatory affairs department, you will be responsible for ensuring compliance with local, regional, and ICH regulations. Your expertise will play a critical role in supporting product development from preclinical stages...

  • Regulatory Affairs Expert

    hace 4 semanas

    Santiago de Querétaro, Querétaro de Arteaga, México Kerry A tiempo completo

    OverviewKerry, a leading player in the food industry, is seeking a highly skilled Regulatory Affairs Expert to join its team. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with relevant regulations and laws.

  • Regulatory Affairs Expert with Strong Clinical Trials Background

    hace 2 semanas

    Ciudad de México, Ciudad de México ICON A tiempo completo

    At ICON, we are seeking a Senior Regulatory Affairs Specialist to join our team in Mexico City.The ideal candidate will have a strong background in clinical trials and regulatory affairs, with experience in preparing and submitting regulatory documents.We offer a competitive salary of $95,000 per year, plus benefits such as annual leave entitlements, health...

  • Regulatory Affairs Expert for Clinical Trials with Senior Leadership

    hace 4 semanas

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

    Job SummaryWe are seeking a seasoned Regulatory Affairs Specialist to lead the preparation, submission, and maintenance of regulatory documents for clinical trials. The ideal candidate will have extensive experience in the pharmaceutical or biotech industry and possess strong knowledge of global regulatory requirements and guidelines.About the RoleDevelop...

  • Clinical Trials Regulatory Affairs Expert

    hace 2 semanas

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

    Senior Regulatory Affairs SpecialistWe're seeking a highly skilled Clinical Trials Regulatory Affairs Expert to join our team at ICON Plc. This is an exciting opportunity to leverage your expertise in regulatory affairs and contribute to the success of our clinical trials.About the Role:Lead the preparation, submission, and maintenance of regulatory...

  • Regulatory Affairs Strategist

    hace 4 semanas

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

    In the role of Regulatory Affairs Strategist at Thermo Fisher Scientific, you will be part of our Regulatory Liaison team, leading on communications with regulatory agencies as part of centralized regulatory submissions including but not limited to the EU CTR process. You will partner with our Regulatory Affairs leads, in providing regulatory affairs...

  • Regulatory Affairs Expert for Mexico

    hace 4 semanas

    Ciudad de México, Ciudad de México Gilead Sciences A tiempo completo

    Gilead Sciences is seeking a highly experienced Regulatory Affairs professional to join our team in Mexico City.About GileadWe are a biopharmaceutical company dedicated to creating a healthier world by bringing life-changing therapies to people with life-threatening diseases. Our mission requires collaboration, determination, and a relentless drive to make a...

  • Regulatory Affairs Professional

    hace 4 semanas

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

    Job SummaryWe are seeking a highly skilled Sr Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our Regulatory Liaison team, you will play a critical role in leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...

  • Clinical Trials Regulatory Affairs Specialist with Expertise in Global Compliance

    hace 2 semanas

    Ciudad de México, Ciudad de México ENGINEERINGUK A tiempo completo

    We are seeking a seasoned Clinical Trials Regulatory Affairs Specialist to join our team at ICON plc, a world-leading healthcare intelligence and clinical research organization. Located in Mexico City, this role offers a unique blend of work flexibility and professional growth opportunities.About the Role:The successful candidate will play a pivotal part in...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Ciudad de México, Ciudad de México 3M A tiempo completo

    Job DescriptionWe are seeking a highly skilled Regulatory Affairs Specialist to join our team in Mexico City.OverviewAs a Regulatory Affairs Specialist, you will play a key role in coordinating regulatory strategy for the Consumer Health Group division. You will provide support and expertise as part of the Regulatory organization, using your knowledge of...

  • Regulatory Affairs Lead

    hace 2 semanas

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

    The Regulatory Affairs Lead for North America at Thermo Fisher Scientific plays a pivotal role in ensuring compliance with local, regional, and ICH regulatory requirements. This dynamic professional provides innovative solutions to support product development from preclinical stages through registration and optimization.Key Responsibilities:Provides senior...

  • Strategic Public Affairs Director Mexico

    hace 1 mes

    Ciudad de México, Ciudad de México Flix Se A tiempo completo

    We're seeking a results-driven Strategic Public Affairs Director to drive our success in Mexico. Based in Mexico City, you'll develop and execute a strategic approach to achieve FlixBus' goals in public affairs.Key Responsibilities:Paint the world green through sustainable mobility solutionsDevelop and implement a comprehensive public affairs strategy across...

  • Senior Public Affairs Specialist

    hace 2 meses

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

    Are you a public affairs and relations expert with a passion for the pharmaceutical industry? We are seeking a Senior Public Affairs Specialist to lead our External Affairs department at Novo Nordisk. As a key member of our team, you will maintain and enhance our positive relations with external audiences, including the general public, shareholders,...

  • Wireless Regulatory Expert

    hace 4 semanas

    Ciudad de México, Ciudad de México Cisco A tiempo completo

    Unlock a rewarding career as a wireless regulatory expert at Cisco. Salary: $150,000 - $200,000 per annum, depending on experience.About the RoleThis challenging position requires a seasoned professional with extensive knowledge of international spectrum regulation and wireless standards. As a key member of our team, you will be responsible for developing...

  • Regulatory Affairs Professional

    hace 4 semanas

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

    Novo Nordisk A/S is seeking a skilled Regulatory Affairs Coordinator to join its GBS Mexico City team.About the RoleThe successful candidate will be responsible for supporting the compilation, submission, and approval of Country Specific Submissions files for designated countries. They will also assist affiliates in reviewing labelling materials and...

  • Regulatory Affairs Expert for Clinical Trials

    hace 4 semanas

    Ciudad de México, Ciudad de México ICON plc A tiempo completo

    At ICON plc, we're seeking a skilled Senior Regulatory Affairs Specialist with experience in clinical trials to join our team.This role will play a pivotal part in ensuring regulatory compliance and facilitating the successful execution of clinical trials, contributing to the advancement of innovative treatments and therapies.The estimated salary for this...

  • Compliance and Regulatory Affairs Professional

    hace 2 semanas

    Ciudad de México, Ciudad de México Moody's A tiempo completo

    About the RoleWe are seeking a highly skilled Compliance and Regulatory Affairs professional to join our team in Mexico City. The successful candidate will be responsible for coordinating compliance and regulatory affairs efforts across multiple jurisdictions, ensuring Moody's Local entities meet domestic regulatory requirements, and facilitating escalation...