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Regulatory Affairs Associate

3 meses atrás

Lisboa, Lisboa, Portugal Hovione Tempo inteiro

Join a Market Leader:
Hovione is an independent family owned international group of companies.

From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

Our people are the main asset for our continued success.

Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.


Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients.

That is why we are In it for life.

You will be responsible to:

Implements and manages the required guidelines and cGMPs for Hovione, providing LEAN based Quality Systems and Tools, controlled, harmonized and aligned with the company's strategic plan, promoting a rigorous and continuous improvement culture to guarantee high quality compliant sites.

Maintains active and efficient communication channels along the several Hovione sites, identifying Quality needs and improvements both from internal and external stakeholders.

Evaluates, advises and provides services and technical support, internally and externally, related to the legal and scientific regulatory requirements in relation to product development, commercialization and optimization across the full product lifecycle to ensure compliance with both global and local regulatory legislation, guidelines, inspections, audits and other regulatory due diligence.

Represents Hovione through communications and negotiations with regulatory authorities, preparing, submitting and managing all matters related to regulatory submissions and licensing for Hovione and customer products; and within professional associations, industry/trade groups.


  • Assist in execution of post approval and shared services compliance activities
  • Compile, prepare and assist in the preparation of updated documentation to be submitted to regulatory authorities
  • Search and select regularly updated information on legislation, regulations and guidelines
  • Prepare routine reports and regulatory agency communications
  • Prepare communications and technical packages for customers
  • Prepare regulatory plans for revised submissions with specific deliverables and timelines
  • Prepare the annual assessment for the submitted filings
  • Compile and prepare updated regulatory filings to authorities: amendments / variations, annual reports
  • Assist in the implementation of internal procedures and systems to track and manage documentation and tasks
  • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice.
  • Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a costeffective manner
  • Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of Hovione ́s policies, systems and procedures (COPs, HBR, SOPs and others).
  • University, or equivalent, qualification in Pharmaceutical Sciences or similar scientific field (mandatory)
  • Requires educational / training experience in Regulatory Affairs
  • Knowledge of Quality and international legislation related to pharmaceutical products
  • Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
  • Fluency in English is a requirement
  • Computer literate with good working knowledge of the MS Office package

Hovione is a proud Equal Opportunity Employer
Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect.

We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.