Clinical Trial Application Coordinator : Buenos Aires, Buenos Aires : Indeed
Buscar empleosBuscar candidatosEmpresas / Publicar empleosCreá un CVIngresarquétítulo, palabras clave o empresadóndeciudad o provinciaBuscar empleosBúsqueda avanzada de empleoClinical Trial Application CoordinatorPfizer Inc.4,849 evaluaciones:Pfizer Inc.4,849 evaluacionesLeé opiniones sobre trabajar en esta empresa.Buenos Aires, Buenos AiresObjective:
The Regulatory Affairs Senior Coordinator PIH is responsible for coordinating all regulatory affairs activities for new and in:line innovative products within the country, ensuring strategist execution defined by the Regulatory Affairs Manager in compliance with Pfizer standards and applicable regulations.
Will support the Regulatory Affairs Manager to contribute to the leading manage and provide strategic direction to develop and execute regulatory strategies and plans for the country and/or products under his/her responsibility, where applicable, assuring a successful execution of the regulatory strategy and maintenance of the products during their complete lifecycle, in full compliance with Pfizer Global Polices and local current Regulations.
Primary Responsibilities
Supports the Regulatory Affairs Manager in the development of registration strategies for new products, including local requirements and expected approval timelines.
Manages and executes all product related variations aligned with the commercial team goals.
Coordinates global teams output to ensure high quality submissions.
Executes the agreed plans by coordinating dossier submission within planned PCO timelines and obtains Regulatory Agency approvals for new chemical entities (NCEs), line extensions, new indications, site registrations, etc to meet PCO launch plans.
Ensures submitted product documents fully meet the local regulatory requirements and Pfizer standards.
Follows:up with the regulatory authority during submission review and ensures all questions/requests/queries are provided/clarified within due time to ensure timely approval of product.
Applies regulatory expertise and ensures all marketed products are in compliance with local and corporate regulatory requirements.
Maintains regular contact/relationship with key regulatory authorities.
Maintains regular contact/relationship with key internal stakeholders in country and above country.
Represents Pfizer at relevant trade association/organizations as back up of Reg. Aff. Manager.
Responsible for tracking and supervising all regulatory activities in the appropriate local tracking tool and Global databases an ongoing basis.
Provides insight of the local regulatory environment to internal stakeholders.
Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory strategies, and decision making. Support to Regulatory Country Head to influence on new sanitary legislation initiatives that could impact the business.
Ensures labeling update in accordance with REG01 process and timelines.
Raises artwork updates / artwork creation, ensuring REG25 process compliance and coordination with internal stakeholders.
Collaborates with appropriate areas within Pfizer with regards to the submission of regulatory documents needed for tender / bids.
Participates in the review / approval process of promotional materials/activities in Company System in accordance with REG08.
Ensures all corporate databases are updated.
Manages archiving of regulatory documents as appropriate following Pfizer standard, ensuring availability in case of audit/inspections.
Ensures adherence to Pfizer Policies / SOPs/IGs and applicable country regulations.
Ensure 100 compliance of P2L training, Anti:corruption Policies and Procedures (MAPP) and any other company requirement.
Technical Skill Requirements
Knowledge of the Local Regulations related to Drug Products including biologic and vaccines regulations and Authorization requests.
Good knowledge of local regulatory
