Regulatory Affairs Manager

hace 5 días

Ciudad de México, Ciudad de México Gilead Sciences, Inc. A tiempo completo
About the Role

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Gilead Sciences, Inc. in Mexico City. As a key member of our Regulatory Affairs team, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.

Key Responsibilities
  • Regulatory Strategy Development
    • Define and execute regulatory strategies to maximize regulatory success and achieve program objectives.
    • Provide strategic and tactical advice to ensure timely and efficient regulatory submissions and life cycle maintenance.
  • Regulatory Compliance
    • Ensure compliance with applicable regulatory requirements and maintain a strong understanding of the regulatory landscape in Mexico.
    • Collaborate with cross-functional teams to ensure regulatory compliance and identify areas for improvement.
  • Stakeholder Engagement
    • Engage with internal and external stakeholders, including regulatory authorities and industry partners.
    • Represent the Regulatory Affairs function at international project team meetings and contribute to cross-functional initiatives.
  • Regulatory Submissions and Approvals
    • Accountable for regulatory submissions and approvals, in collaboration with internal and external stakeholders.
    • Responsible for anticipating and quantifying risks and proposing solutions, including the probability of success.
  • Regulatory Environment Monitoring
    • Actively monitor and anticipate trends that impact the regulatory environment and adapt regulatory strategies in a timely manner.
    • Facilitate manufacturing sites registration in line with national requirements.
Requirements
  • Education and Experience
    • BSc, MSc or PhD in a scientific discipline with extensive experience in the pharmaceutical/biotechnology industry in Mexico.
    • Extensive knowledge of the regulatory landscape in Mexico.
  • Skills and Behaviors
    • Self-motivator, enthusiastic, tenacious, and energizing.
    • Proactive and open to share, advise, and educate colleagues across the organization.
    • Agile in an evolving environment.
    • Resilient with the ability to influence and deliver in an ambiguous environment.
    • Ability to engage stakeholders and manage multiple stakeholders to achieve objectives.
    • Ability to transition from strategic to operational to deliver objectives according to established plans and business needs.
    • Excellent verbal and written English, negotiation, influence, and interpersonal communication skills.
    • Detailed oriented.
    • Good team player.
Gilead Core Values
  • Integrity (Doing What's Right)
  • Inclusion (Encouraging Diversity)
  • Teamwork (Working Together)
  • Excellence (Being Your Best)
  • Accountability (Taking Personal Responsibility)
Leadership Commitments
  • I AM BOLD in aspiration and AGILE in execution.
  • I CARE and make time for people.
  • I LISTEN, speak openly, and explain the 'why.'
  • I TRUST others and myself to make sound decisions.
  • I OWN the impact of my words and actions.

  • Regulatory Affairs Manager

    hace 5 días

    Ciudad de México, Ciudad de México Upfield A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Upfield in Mexico City. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with regulatory requirements in Central and Latin America.Key ResponsibilitiesDevelop and implement regulatory strategies to support product...

  • Regulatory Affairs Manager

    hace 3 días

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

    Job DescriptionWe are seeking a highly skilled and experienced Regulatory Affairs professional to join our team at Gilead Sciences. As a Regulatory Affairs Manager, you will play a critical role in advancing our therapeutics and ensuring regulatory compliance.Key ResponsibilitiesDevelop and Execute Regulatory Strategies: Define, develop, and execute...

  • Regulatory Affairs Manager

    hace 4 días

    Ciudad de México, Ciudad de México Gilead A tiempo completo

    About GileadGilead is a leading biopharmaceutical company dedicated to creating a healthier world for all people. With over 35 years of experience, we have developed therapies that improve lives and ensure access to these therapies across the globe.We are a collaborative and ambitious team that tackles the world's biggest health challenges. Our employees are...

  • Regulatory Affairs Manager

    hace 4 semanas

    Ciudad de México, Ciudad de México Fyte A tiempo completo

    Regulatory Affairs Manager CDMX En Fyte estamos en búsqueda de un Regulatory Affairs Manager para una empresa farmacéutica internacional Buscamos conectar con Profesionales con al menos 10 años de experiencia laboral en Asuntos Regulatorios para la industria farmacéutica. ¿Qué responsabilidades tendrás?Asegurar que todos los productos y procesos...

  • Regulatory Affairs Manager II

    hace 5 días

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

    Job SummaryMccormick & Company, a leading manufacturer and distributor of spices, seasonings, and condiments, is seeking a highly skilled Regulatory Affairs Manager II to join our team in Mexico City, Mexico.About the RoleThe successful candidate will be responsible for leading a team of regulatory professionals who will develop and implement regulatory...

  • Regulatory Affairs Specialist

    hace 5 días

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

    Job SummaryThermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our Regulatory Liaison team. As a key member of our team, you will be responsible for leading communications with regulatory agencies and providing regulatory affairs strategy and technical/project leadership on a regional/global level.Key...

  • Regulatory Affairs Specialist

    hace 5 días

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

    **Job Summary**Thermo Fisher Scientific is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Liaison team, you will be responsible for leading on communications with regulatory agencies as part of centralized regulatory submissions.**Key Responsibilities**Provide regulatory advice and carry out...

  • Regulatory Affairs Specialist

    hace 5 días

    Ciudad de México, Ciudad de México Fenixfarma Mexico City, Mexico A tiempo completo

    Job Title: Regulatory Affairs CoordinatorCompany: Fenixfarma Mexico City, MexicoJob Summary:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Mexico City. The successful candidate will be responsible for ensuring compliance with local health regulations and leading a team of regulatory specialists to achieve product...

  • Regulatory Affairs Specialist

    hace 5 días

    Ciudad de México, Ciudad de México QuidelOrtho A tiempo completo

    About the OpportunityQuidelOrtho, a world-leading in vitro diagnostics company, is seeking a highly skilled Regulatory Affairs Associate to join our team. With a strong presence in over 130 countries, we provide fast, accurate, and consistent testing solutions where and when they are needed most.Our company culture prioritizes employee happiness,...

  • Regulatory Affairs Specialist

    hace 5 días

    Ciudad de México, Ciudad de México MMATISS A tiempo completo

    Key Responsibilities:As a Regulatory Affairs Coordinator at MMATISS, you will be responsible for ensuring compliance with local regulations by performing submissions and tracking the progress of approvals. You will implement regulatory processes to avoid warnings or rejections, including obtaining protocol, site, marketing, and importation/exportation...

  • Regulatory Affairs Specialist

    hace 5 días

    Ciudad de México, Ciudad de México Philips Iberica SAU A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Philips Iberica SAU. As a key member of our Regulatory Affairs team, you will be responsible for guiding and supporting our businesses, markets, and supporting functions in the Mexico market to ensure compliance with regulatory requirements.Key...

  • Senior Regulatory Affairs Specialist

    hace 5 días

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

    Job SummaryWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our team at ICON plc. As a key member of our regulatory affairs department, you will play a critical role in ensuring compliance with regulatory requirements and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory Document Preparation...

  • Regulatory Affairs Director

    hace 5 días

    Naucalpan de Juárez, México Hydro - US Facilities A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Hydro - US Facilities. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements and developing strategies to achieve regulatory approvals.Key ResponsibilitiesDevelop and implement regulatory strategies for...

  • Regulatory Affairs Specialist

    hace 5 días

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

    Job SummaryICON Plc is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory affairs department, you will play a pivotal role in ensuring regulatory compliance and facilitating the successful execution of clinical trials.Key ResponsibilitiesRegulatory ComplianceLead the preparation, submission, and...

  • Regulatory Affairs Specialist

    hace 5 días

    Ciudad de México, Ciudad de México GSK A tiempo completo

    Regulatory Affairs Specialist Role at GSKThis position is responsible for coordinating activities related to compliance with the Regulatory Framework in Mexico, aligned to the needs and strategies defined by the different participating areas of GSK, focused on the submission and approval of administrative and technical modifications.Key...

  • Regulatory Affairs Director

    hace 5 días

    Naucalpan de Juárez, México Merck Group A tiempo completo

    About the Role:We are seeking a highly skilled Regulatory Affairs Manager to join our team at Merck Group. As a key member of our Regulatory Affairs team, you will be responsible for ensuring compliance with local regulations and guidelines for our pharmaceutical products and medical devices.Key Responsibilities:Develop and implement regulatory strategies...

  • Regulatory Affairs Specialist LATAM

    hace 5 días

    Ciudad de México, Ciudad de México Medtronic A tiempo completo

    About the RoleWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for medical devices in the LATAM region.Key ResponsibilitiesCoordinate and prepare document packages for regulatory submissions,...

  • Regulatory Affairs Specialist

    hace 4 días

    Ciudad de México, Ciudad de México Kenvue A tiempo completo

    About KenvueKenvue, part of the Johnson & Johnson Family of Companies, is a leading healthcare company that believes in the extraordinary power of everyday care. With a rich heritage and propelled forward by science, our iconic brands are trusted by millions of consumers who use our products to improve their daily lives.Job SummaryWe are seeking a highly...

  • Regulatory Affairs Specialist

    hace 5 días

    Ciudad de México, Ciudad de México Procter & Gamble A tiempo completo

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Procter & Gamble. As a key member of our regulatory team, you will be responsible for preparing and approving submission-ready documents for renewals, variations, or rollouts, maintaining existing product licenses for medicinal products or Food Supplements, and...

  • Regulatory Affairs Specialist

    hace 5 días

    Ciudad de México, Ciudad de México Psi CRO Ag A tiempo completo

    At Psi CRO Ag, we are seeking a highly skilled Regulatory Officer to join our team of experts in regulatory and ethics submissions of clinical studies.Key ResponsibilitiesPrepare clinical trial submission dossiers for regulatory and ethics authorities, ensuring compliance with all relevant regulations and guidelines.Communicate effectively with regulatory...