Summary
Overview
Work History
Education
Skills
Languages
Timeline
Generic

Nicolás Esteban Duque Acosta

Bogotá

Summary

Versatile Senior Manager specializing in Pharmaceutical Regulatory Affairs and skilled at planning, implementing and overseeing key improvements to drive business growth and efficiency. History of cultivating an open culture with free exchange of information. Pursuing new professional challenges with a growth-oriented company.

Overview

5
5
years of professional experience

Work History

Hub Submission Senior Manager

Pfizer
12.2022 - Current
  • Led complex regulatory projects, ensuring timely completion and strategic alignment with business objectives.
  • Implemented operational efficiencies in regulatory submission processes, achieving milestones and compliance with global standards.
  • Interpreted regulatory guidelines to develop and implement business requirements at local and regional levels.
  • Optimized resource management through flexible resourcing and global load sharing, enhancing project efficiency.
  • Mentored and trained colleagues as a Subject Matter Expert, improving team capability and knowledge.
  • Managed escalation and resolution of issues impacting submission builds and global delivery logistics.
  • Spearheaded the withdrawal strategy in collaboration with regulatory teams, ensuring strategic execution.
  • Supported multiple regions, leveraging global tools to maintain high compliance and operational standards.
  • Ensured scientific rigor in data submissions, contributing to sound regulatory decisions.
  • Maintained comprehensive product and license information in tracking databases.
  • Directed curriculum development and training compliance, producing key metrics and compliance reports.
  • Provided direct support to Human Resources in talent acquisition as a Subject Matter Expert, being crucial in the selections of new colleagues and interns.
  • Led cross-functional teams to achieve project milestones and deliver high-quality results.
  • Provided strong leadership to enhance team productivity and morale.
  • Improved team performance by providing comprehensive training and fostering a collaborative work environment.
  • Reduced costs, optimized resource allocation, and improved efficiency in managing projects.

Hub Submission Manager

Pfizer
04.2021 - 12.2022
  • Directed operational support for Hub Submission team, coordinating regulatory submissions for global markets.
  • Managed logistical and technical aspects of dossier development, ensuring timely delivery of high-quality regulatory submissions.
  • Oversaw initial applications and lifecycle updates, ensuring compliance and maintenance of regulatory standards.
  • Delivered projects on time and within quality standards, adhering to policies, SOPs, and service level agreements.
  • Applied advanced knowledge of regulatory submissions to meet business and regulatory requirements.
  • Ensured compliance through rigorous use of technical tools, practices, and quality control measures.
  • Addressed and resolved issues affecting submission timelines, quality, or compliance.
  • Collaborated on complex projects, managing time effectively to meet team targets and project plans.
  • Managed and motivated employees to be productive and engaged in work.
  • Maximized performance by monitoring daily activities and mentoring team members.
  • Accomplished multiple tasks within established timeframes.

Regulatory Affairs Analyst

SC Johnson & Son
10.2019 - 04.2021
  • Managed registration and regulatory compliance for domestic hygiene products across 12 Latin American countries.
  • Contributed to commercial projects, regulatory strategies, and planning, enhancing market penetration and compliance.
  • Participated in regulatory updates and advertising compliance for household pesticides and cosmetics.
  • Coordinated registration processes, ensuring timely market entry and regulatory adherence.
  • Reduced risk of non-compliance penalties with proactive identification and resolution of potential issues.
  • Contributed to cost reduction efforts by identifying opportunities for process improvement within regulatory affairs operations.
  • Coordinated timely responses to regulatory inquiries, demonstrating organizational commitment to transparency and cooperation.
  • Enhanced company reputation through diligent monitoring of industry regulations and updating policies accordingly.
  • Assisted in the development of strategic plans for addressing new or changing regulations, ensuring seamless transitions for the organization.
  • Improved regulatory compliance by conducting thorough audits and assessments of internal processes.

Intern Pharmacist

Pharmetique Labs
03.2019 - 09.2019
  • Supported Pharmacovigilance Management Area, preparing technical-scientific documentation for 14 countries.
  • Evaluated and reported adverse events, conducting causality assessments and prioritizing daily cases.
  • Ensured timely and accurate completion of reports under the direction of the Associate Pharmacovigilance and Safety Director.
  • Educated patients on proper medication administration techniques, potentially reducing adverse effects or complications from incorrect usage.
  • Increased efficiency in the pharmacy by implementing best practices for proper storage, organization, and handling of medications.

Education

Pharmacy, Bachelor -

Universidad Nacional De Colombia
Bogota
11.2019

Skills

  • Interpersonal relationships
  • Team Leadership
  • Negotiation and Conflict Resolution
  • Communication
  • Troubleshooting and problem resolution
  • Data-driven decision-making
  • Talent Development
  • Teamwork and Collaboration
  • Strategic Planning
  • Cross-Functional Collaboration
  • Operations Management
  • Cross-functional Team Coordination

Languages

Spanish
Native or Bilingual
English
Full Professional

Timeline

Hub Submission Senior Manager

Pfizer
12.2022 - Current

Hub Submission Manager

Pfizer
04.2021 - 12.2022

Regulatory Affairs Analyst

SC Johnson & Son
10.2019 - 04.2021

Intern Pharmacist

Pharmetique Labs
03.2019 - 09.2019

Pharmacy, Bachelor -

Universidad Nacional De Colombia

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Nicolás Esteban Duque Acosta