Summary
Overview
Work history
Education
Skills
Personal Information
Languages
Affiliations
Timeline
Generic

Susana Sargento

Malveira

Summary

Regulatory Affairs Senior Specialist with significant experience in the pharmaceutical industry, including roles in Competent Authority and multinational organizations. Demonstrated success in developing and implementing regulatory strategies for branded and generic drugs, OTC products, medical devices, and food supplements. Strong ability to collaborate across departments to ensure compliance with marketing and sales policies while adhering to regulatory and medical standards. Currently serves as Senior Regulatory Affairs Manager at Teva Portugal, managing multiple product categories and leading local regulatory affairs and market access initiatives.


Regulatory affairs professional with career focus on ensuring compliance and managing regulatory submissions within pharmaceutical industry. Skilled in navigating complex regulations and building strong relationships with regulatory authorities, leading to successful product approvals and market entries. Expertise in risk management and strategic planning drives consistent regulatory compliance and business growth.

Overview

24
24
years of professional experience

Work history

Senior Regulatory Affairs Manager

Teva Portugal
Porto Salvo, Oeiras
09.2012 - 06.2025

Direct backup of Regulatory Affairs Director, ensuring seamless operations.

  • Ensured timely launches of drugs according to annual Work Plan for Generic and Brand products.
  • Collaborated in implementing Local Department Standard Operating Procedures aligned with regulatory compliance.
  • Managed local implementation of Drug Shortage notifications, minimizing exposure risks for TEVA.
  • Oversaw compliance checks on pharmacovigilance communications to uphold standards.
  • Coordinated artwork management for new product launches, brand implementations, and Safety Variations.
  • Supervised two Officers to enhance departmental efficiency.

Head of Local Regulatory Affairs Team – Assigment

TEVA Pharma Produtos Farmacêuticos Lda
Porto Salvo, Oeiras
08.2017 - 02.2018
  • Coordinated Regulatory Affairs team of five direct reports, reporting to EU Regional RA Head.
  • Served as primary contact for EU Regional RA Head and Local General Manager.
  • Managed local Regulatory Affairs budget and overall team performance.
  • Contributed to Local Compliance Committee to ensure adherence to regulations.
  • Liaised with Local Business Development and Portfolio Manager for alignment on launch strategies.

Nominated Signatory & Medical Information Manager

AstraZeneca, Produtos Farmacêuticos Lda
Queluz de Baixo
09.2011 - 07.2012
  • Provided expert guidance on regulatory matters during the decision-making process at board meetings.

Head of Local Regulatory Affairs Team - Interim

AstraZeneca, Produtos Farmacêuticos Lda
Queluz de Baixo
10.2010 - 01.2011

Reported to Medical Direction while overseeing internal coordination of regulatory affairs team.
Managed a team of three, ensuring effective communication with Global Team.

Regulatory affairs manager

Pharma Industry / RA Consultant Company / INFARMED
Lisbon
01.2001 - 10.2010
  • Liaised with health authorities for successful product registrations.
  • Trained new employees effectively reducing their learning curve and increasing productivity sooner than usual.
  • Developed standard operating procedures to streamline routine tasks and improve productivity.
  • Collaborated with international teams for effective management of global projects.
  • Reviewed marketing materials for compliance with advertising regulations protecting the company against legal implications.
  • Streamlined internal processes to enhance efficiency in regulatory affairs.

Education

Bachelor of Science - Pharmaceutical Sciences

Faculdade de Farmácia da Universidade de Lisboa
Lisbon, Portugal

Master of Science - Specialist in Regulatory Affairs and Pharmaceutical Regulations

Ordem dos Farmacêuticos
Lisbon, Portugal

Skills

  • Familiarity with pharmaceutical law
  • Product registration
  • Regulatory intelligence
  • Medical device regulations
  • Innovation and adaptability
  • Leadership capabilities
  • Legal requirements knowledge
  • Communication skills
  • Problem-solving
  • Cross-functional teams experience

Personal Information

Date of birth: 04/29/76

Languages

English
Advanced
French
Beginner
Spanish
Elementary

Affiliations

  • Reading, Relaxing, Travel

Timeline

Head of Local Regulatory Affairs Team – Assigment

TEVA Pharma Produtos Farmacêuticos Lda
08.2017 - 02.2018

Senior Regulatory Affairs Manager

Teva Portugal
09.2012 - 06.2025

Nominated Signatory & Medical Information Manager

AstraZeneca, Produtos Farmacêuticos Lda
09.2011 - 07.2012

Head of Local Regulatory Affairs Team - Interim

AstraZeneca, Produtos Farmacêuticos Lda
10.2010 - 01.2011

Regulatory affairs manager

Pharma Industry / RA Consultant Company / INFARMED
01.2001 - 10.2010

Bachelor of Science - Pharmaceutical Sciences

Faculdade de Farmácia da Universidade de Lisboa

Master of Science - Specialist in Regulatory Affairs and Pharmaceutical Regulations

Ordem dos Farmacêuticos
Susana Sargento