Regulatory Affairs Specialist
hace 6 días
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.
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Regulatory Affairs Specialist
hace 4 semanas
Ciudad de México Solventum A tiempo completo**Regulatory Affairs Specialist, Mexico (Solventum)****3M Health Care is now Solventum**At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and...
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Regulatory Affairs Specialist
hace 1 día
Ciudad de México Solventum A tiempo completo**Regulatory Affairs Specialist, Mexico (Solventum)** **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material...
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Regulatory Affairs Specialist
hace 1 semana
Ciudad Juarez, México BEPC Inc A tiempo completo**Regulatory Affairs Specialist**- Develop and maintain regulatory strategies for the development, registration, and commercialization of **medical devices**:- Communicate with regulatory authorities to obtain timely approvals for medical devices- Review and approve labeling, marketing, and promotional materials to ensure compliance with regulations- Monitor...
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Regulatory Affairs Specialist
hace 1 semana
Ciudad de México Medtronic A tiempo completoAt Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.A Day in the LifeLead and prepare RA meetings (regulatory status) involving the OU's under their responsibility....
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Regulatory Affairs Specialist
hace 6 días
Santiago de Querétaro, México Mars, Incorporated and its Affiliates A tiempo completoJob Description: Champion Petfoods is seeking a Regulatory Affairs Specialist to support compliance and registration activities for pet foods in Mexico and other markets in the Latin America region. This position will assist with the administration of all functions associated with regulatory requirements to ensure open borders and compliance for the business...
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Regulatory Affairs Specialist
hace 6 días
Santiago de Querétaro, México Mars, Incorporated and its Affiliates A tiempo completoJob Description: Champion Petfoods is seeking a Regulatory Affairs Specialist to support compliance and registration activities for pet foods in Mexico and other markets in the Latin America region. This position will assist with the administration of all functions associated with regulatory requirements to ensure open borders and compliance for the business...
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Regulatory Affairs Specialist
hace 4 días
Santiago de Querétaro, México Marsveterinary A tiempo completoChampion Petfoods is seeking a Regulatory Affairs Specialist to support compliance and registration activities for pet foods in Mexico and other markets in the Latin America region. This position will assist with the administration of all functions associated with regulatory requirements to ensure open borders and compliance for the business in Mexico and...
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Regulatory Affairs Specialist
hace 4 días
Santiago de Querétaro, México Marsveterinary A tiempo completoChampion Petfoods is seeking a Regulatory Affairs Specialist to support compliance and registration activities for pet foods in Mexico and other markets in the Latin America region. This position will assist with the administration of all functions associated with regulatory requirements to ensure open borders and compliance for the business in Mexico and...
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Latam Regulatory Affairs Specialist
hace 1 día
Santiago de Querétaro, México Mars, Incorporated And Its Affiliates A tiempo completoLatAm Regulatory Affairs Specialist - Pet Food ComplianceMXN 40,000 - 60,000A leading global pet food company is looking for a Regulatory Affairs Specialist to support compliance and registration activities for pet foods in Mexico and Latin America. The ideal candidate will have experience in the industry, strong regulatory knowledge, and excellent...
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Latam Regulatory Affairs Specialist
hace 1 día
Santiago de Querétaro, México Mars, Incorporated And Its Affiliates A tiempo completoLatAm Regulatory Affairs Specialist - Pet Food ComplianceMXN 40,000 - 60,000A leading global pet food company is looking for a Regulatory Affairs Specialist to support compliance and registration activities for pet foods in Mexico and Latin America. The ideal candidate will have experience in the industry, strong regulatory knowledge, and excellent...
