Regulatory Affairs Specialist – Consultant

hace 2 semanas

Ciudad de México, Ciudad de México ClinChoice A tiempo completo

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Specialist – Consultant (Sr. Product License Maintenance Manager, (PLM) Compliance Support) for 12 months Contract with possibility of extension to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client's counterparts.  

Job Description

Sr. Product License Maintenance Manager, (PLM) Compliance Support

Location - Mexico (Remote) - Contract

Responsibilities

  • Accountable for reviewing new certificate requests and forwarding to relevant suppliers for processing
  • Responsible for NDA Annual Report compilation and Drug Listing submissions to

FDA

  • Manages multiple tasks simultaneously to ensure performance metrics and filing deadlines are achieved according to agreed targets and BOH due dates.
  • Liaise with where necessary  necessary  to collect the information needed to submit the certificate request to the Contractor. If re- work is identified, track all rework through systems.
  • Forward request to the identified Contractor for    processing,    within    the    timeframes identified by the relevant project team.
  • If  required,  manage  legalization  through Consular     Services     ensuring     relevant administration,  fees   are   completed   and timelines adhered to.
  • Communicate with requestor, Contractor or Consular   Service   to   ensure   request   is processed,    queries    are    answered    and timelines are met.
  • Project       manage       multiple       requests simultaneously, ensuring filing deadlines are reached and next action dates are maintained in real time by pulling pending reports from systems.
  • Escalate to Client and Contractor point of contact when timelines may not be reached.
  • Maintain Clients systems and process throughout processing of request to ensure real time reflection of request is visible to all

users.

  • To seek approval from Clients end lead, should any certificates require fast tracking.
  • Supports  delivery  of  electronic  and  paper regulatory transactions and electronic review aids  in  support  of  Drug  Listings,  Drug Establishment Registrations, And (A) NDA Annual Report submission to FDA
  • Continuous     Improvement     of     selected processes     relating     to     human     health submissions and selected drug and non-drug specific projects and related activities e.g., Drug listing and Establishment registrations,
  • Delivery  of  Product  License  Maintenance Portfolio in a timely and quality manner

Minimum Requirements

  • 3+ years Regulatory experience
  • Experience submitting US Annual Reports
  • Demonstrated ability to support international product approval
  • Demonstrates ability to work within a demanding environment with a strong focus on quality and timelines.
  • Proven technical aptitude and ability to quickly learn and apply new software, regulations and quality standards.
  • Can demonstrate leadership and team skills.
  • Advanced Microsoft Office Suite skills.
  • Highly efficient communicator.
  • Acts decisively and seizes accountability
  • Bachelor's degree Level (desirable or equivalent work experience.
  • Familiarity with pharmaceutical organizational Structures.

  • CMC Regulatory Affairs Profesionals

    hace 1 semana

    Ciudad de México, Ciudad de México Parexel A tiempo completo

    When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at...

  • Regulatory affairs specialist

    hace 4 días

    Ciudad de México, Ciudad de México ClarkeModet A tiempo completo

    Clarke+Modet is a company specialized in Intellectual Property that manages regulatory processes within the healthcare sector. It carries out procedures before COFEPRIS related to medicines and medical devices, ensuring regulatory compliance for their commercialization in Mexico.Education• QFI – Industrial Pharmaceutical Chemist• QFB – Pharmaceutical...

  • Regulatory Affairs Coordinator

    hace 7 días

    Ciudad de México, Ciudad de México Novo Nordisk, Inc. A tiempo completo

    Regulatory Affairs CoordinatorCategory: Reg Affairs & Safety PharmacovigilanceLocation:Ciudad de México, Ciudad de México, MXRegulatory AffairsMexico City, MexicoAre you passionate about regulatory compliance and ensuring patient safety? Do you have experience navigating complex regulatory landscapes and working with global stakeholders? If so, we invite...

  • Regulatory Affairs Manager

    hace 2 semanas

    Ciudad de México, Ciudad de México Eli Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Regulatory Affairs Coordinator

    hace 1 semana

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

    Regulatory AffairsMexico City, MexicoAre you passionate about regulatory compliance and ensuring patient safety? Do you have experience navigating complex regulatory landscapes and working with global stakeholders? If so, we invite you to join our team as a Regulatory Affairs Coordinator in Mexico City. Apply today and make a difference in the lives of...

  • Public Affairs Consultant

    hace 1 semana

    Ciudad de México, Ciudad de México another A tiempo completo

    OUR JOB IS TO REVOLUTIONIZE THE STRATEGIC COMMUNICATION  We are , a global communications agency founded in 2004. we have been transforming the way things are done. Revolution is in our DNA, and it guides every project we undertake. Our mission is clear: to create inspirational, powerful, and creative storytelling that is always culturally relevant,...

  • Regulatory Affairs Lead

    hace 1 semana

    Ciudad de México, Ciudad de México Viatris A tiempo completo

    Viatris Healthcare México S. de R.L. de C.VAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:  Access – Providing high quality trusted...

  • Regulatory Affairs Lead

    hace 1 semana

    Ciudad de México, Ciudad de México Viatris A tiempo completo

    Viatris Healthcare México S. de R.L. de C.VAt VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.Viatris empowers people worldwide to live healthier at every stage of life.We do so via:Access – Providing high quality trusted...

  • Medical Affairs Specialist

    hace 1 semana

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

    Medical Affairs Specialist - Brazil &/or Mexico - Homebased or Office with FlexICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently...

  • Specialist, Commercial Quality and Regulatory Affairs

    hace 1 semana

    Ciudad de México, Ciudad de México Danaher Corporation A tiempo completo

    Bring more to life.Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Beckman Coulter Diagnostics, one of Danaher's 15+ operating companies, our work saves lives—and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging...