Product License Maintenance, Associate - Suba, Colombia - Pfizer

Pfizer
Pfizer
Empresa verificada
Suba, Colombia

hace 1 mes

Carolina González

Publicado por:

Carolina González

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Descripción

A Product License Maintenance Manager will ensure Pfizer maintains compliance by delivering the portfolio of one or multiple applicable regulatory obligations.


Product License Maintenance Group comprises coordination of regulatory compliance starting at drug development stage and reaching through the lifespan of the Product.


Once a New Drug Application is approved, a host of activities are required to set up and maintain the new drug label and essential product information (known as drug listing data) to Pfizer's website and FDA, the National Library of Medicine (Daily Med) Website and the Drug Registration and Listing System team.

Compliance activities continue with coordination of information in support of New Drug Application Annual Reports and NDA Periodic Reports.

In addition, in support of EEA markets, team members will be accountable for partnering with appropriate vendors in submission of A57 records to the EMA.

Team responsibilities also include managing the coordination of regulatory ancillary documents (including legalization) and drug samples to support registration and approval products in international markets.


Responsibilities:

Associate

  • Supports delivery of electronic and paper regulatory transactions and electronic review aids in support of Drug Listings, Drug Establishment Registrations, certificates and samples sourcing, XEVMPD submissions and other post market scheduled regulatory compliance activities in accordance with 21CFR
  • Continuous Improvement of selected processes relating to human health submissions and selected drug and nondrug specific projects and related activities e.g. Drug listing and Establishment registrations,
  • Delivery of Product License Maintenance Portfolio in a timely and quality manner.
  • Contributes to the completion of project tasks and/or milestones
  • Organizes own work to meet project task deadlines
  • Learns and applies basic team effectiveness skills (e.g., commitment, feedback, consensus management) within context of immediate Work Team.
  • Has fundamental knowledge of the principles and concepts of the discipline.
  • Applies technical skills to achieve assigned tasks
  • Contributes to the completion of routine Work Team related tasks.
  • Uses established procedures and methodologies.
  • Uses technical skills to achieve assigned regulatory operational responsibilities to support submissions to the Regulatory Authorities.
  • Applies fundamental knowledge of the relevant regulatory industry and local business environment.
  • Has fundamental knowledge of clinical, regulatory and/or other relative stakeholder groups.
  • Makes decisions that require choosing between limited options to resolve problems basic in their complexity
  • Performs work in a structured environment under direction from supervisor
  • Decisions impact own work and have limited effect on projects.
  • Decisions have limited effect on the delivery of scheduled work and may affect allocation of existing resources.
  • Exercises judgment to complete assigned tasks and has significant reliance on supervisor
  • Works in a structured environment under direct supervision
  • Uses established procedures to perform assigned tasks
  • Asks for guidance from other colleagues
  • Work is regularly reviewed for soundness of technical judgment, completeness, and accuracy.
  • Communicates straightforward information, asks questions and checks for understanding
  • Participates and contributes as a team member
  • Is responsible for certain team deliverables.

Qualifications:

  • Undergraduate degree plus relevant experience as below, or
  • Demonstrated ability to function autonomously in a matrix environment.
  • Regulatory Expertise: Demonstrated knowledge of Regulatory compliance requirements, processes and systems
  • Demonstrated Project Managements Skills: Competent illustration of processes, tools and techniques for planning and monitoring multiple complex projects to established deadlines.
  • Technology: Experience and competency with Regulatory software, XML, Document Management, regulatory milestone reporting tools.

Core Competencies:

  • Functional/Technical Skills has the functional and technical knowledge and skills to do the job at a high level of accomplishment
  • Acts Decisively makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision
  • Seizes Accountability will stand up and be counted; doesn't shirk personalresponsibility; can be counted on when times are tough; willing to be the only champion for an idea or position; is comfortable working alone on a tough assignment
  • Change Agile can effectively cope with change; can shift gears comfortably; can decide and act without having the total picture; isn't upset when things are up in the air; doesn't have to finish things before moving on; can comfortably handle risk and uncertainty
  • Peer Relationships
- can quickly find common ground and solve problems for t
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