Regulatory Affairs Specialist

hace 2 semanas

Mexico City 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 aRegulatory Affairs Specialist – Consultant (Sr. Product License Maintenance Manager, (PLM) Compliance Support)for 12 months Contract with possibility of extensionto 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 DescriptionSr. Product License Maintenance Manager, (PLM) Compliance SupportLocation - Mexico (Remote) - ContractResponsibilitiesAccountable for reviewing new certificate requests and forwarding to relevant suppliers for processingResponsible for NDA Annual Report compilation and Drug Listing submissions toFDAManages 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 allusers.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 FDAContinuous 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 mannerMinimum 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.

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