Serafim Duarte

Serafim Duarte Email and Phone Number

Regulatory Affairs and Quality Assurance Director @ Andreia Professional
Porto, PT
Serafim Duarte's Location
Porto Metropolitan Area, Portugal
Serafim Duarte's Contact Details

Serafim Duarte personal email

About Serafim Duarte

Accomplished regulatory affairs professional with extensive knowledge of regulatory and quality requirements over two decades of experience in the cosmetic industry. Proven track record of successfully navigating complex regulatory landscapes, ensuring compliance, and obtaining necessary approvals for products launch and site activation. Strong background in production management, quality assurance, and site activation, with a keen eye for optimizing production lines layout design. A strategic leader who excels in driving cross-functional, cross-department collaboration and guiding teams to achieve goals efficiently. Successfully expanded product market presence into new territories (North Africa, Middle East, North and South America), navigating international regulations and fostering partnerships with regulatory agencies. Crafted effective regulatory strategies, accelerating product development timelines and minimizing time-to-market while maintaining compliance. Due demonstrated proficiency in handling diverse product portfolios, including medical devices, biocides, medicinal products meeting regulatory requirements for each category, since 2016, have been leading regulatory affairs teams for renowned cosmetics companies, overseeing product registrations, submissions, and approvals worldwide.During his career mentored and motivated teams to deliver exceptional performance, fostering a culture of innovation and continuous improvement.Recognized, beyond the domain of technical aspects, as having a high capacity of delivering results, by permanent concern in optimizing resources and processes, while improving efficiency.Good skills in the development of professional relationships, hierarchical and non-hierarchical, internal and external, as a facilitator of project management.

Serafim Duarte's Current Company Details
Andreia Professional

Andreia Professional

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Regulatory Affairs and Quality Assurance Director
Porto, PT
Employees:
39
Serafim Duarte Work Experience Details
  • Andreia Professional
    Regulatory Affairs And Quality Assurance Director
    Andreia Professional
    Porto, Pt
  • Andreia Professional
    Regulatory Affairs & Quality Assurance Director
    Andreia Professional Nov 2001 - Present
    Matosinhos, Porto, Portugal
    Responsible for all regulatory and quality operations, while providing coordination and guidance to the production department. Main focus was to ensure the legal compliance of the company products in new markets, that today represent over 30% of the company turnover, and is the company main growth factor. Main Results and Projects• Preparation of documents for market access in countries outside European Union (EU)• Elaboration of the new documents required in the EU - PIFs• Strengthening of relationships with the suppliers• Layout design of the production zone after a fire destroyed our facilities – person of contact for all construction/equipment suppliers • Coordination of NPD teams, point of contact for all departments and suppliers• Creation of the company Customer Support Unit, and Post Market Cosmetic surveillance • Technical and legal support for Commercial teams
  • Andreia Professional
    Production Manager
    Andreia Professional Dec 2003 - Dec 2012
    Gondomar, Porto, Portugal
    Responsible for all manufacturing activities, while still performing the previous work.Main Results and Projects• Optimization of the production procedures and protocols to increase output and decrease delivery time.• New warehouse layout – optimization of the space and workflow• Responsible for the third party production requests/manufacturing – from initial discussions with the client, to formulation development, pricing, ordering rawe materials, packaging, labels, manufacturing, delivery• Negotiation with suppliers – ensure timely delivery of raw materials and packaging• Designing the layout of the new equipments, increase production capability and adding new lines of products• New products development – developed several new products that went on to become best sellers• Redesign and increase on the total manufacturing area (from 200 to 600 square meters)• Responsible for the company import and export transportations/Customs
  • Andreia Professional
    Regulatory Specialist, Market Access And Labelling
    Andreia Professional Nov 2001 - Dec 2003
    Gondomar, Porto, Portugal
    Responsible for ensuring the legal compliance of the company and its products. Report to general-manager.Main Results and Projects• Review of all product conformity with Portuguese and European legislation.• Review and update of all product labelling, to become compliant.• Registration of all products with the competent authorities.• Development of new formulations – 2 became company best sellers.
  • Hidow Europ
    Technical Responsible
    Hidow Europ Jan 2020 - Present
    Portugal
    In charge of all legal and technical matters, and support to the commercial team. Report to general-manager.Main Results and Projects• Review of all product conformity with Portuguese and European legislation.• Review and update of all product labelling, to become compliant.• Registration of all products with the competent authorities• Responsible for importations, coordination with Customs and competente authority
  • Smart Separations Ltd
    Technical Consultant
    Smart Separations Ltd Jan 2021 - Jan 2022
    Braga, Braga, Portugal
    Responsible for ensuring the legal compliance of the company and its products. Report to general-managerMain Results and Projects• Definition of a regulatory strategy for market launch.• Review of all product conformity with Portuguese and European legislation.• Review and update of all product labeling, to become compliant.• Research and preparation of documents for market access in several countries
  • Cann10 Portugal
    Technical Manager
    Cann10 Portugal Jan 2016 - May 2020
    Portugal
    Responsible Person In charge of all legal and technical matters. Report to CEO.Main Results and Projects• Research and contact with the competent authorities, to understand the requirements needed to obtain license to start operations• Creation of the documents required to obtain the license. License achived in March 2020.
  • Hummingbird Unipessoal Lda
    Technical Responsible
    Hummingbird Unipessoal Lda Apr 2013 - Jan 2019
    Portugal
    Responsible Person In charge of all legal and technical matters. Report to general-manager.Main Results and Projects• Review of all product conformity with Portuguese and European legislation.• Review and update of all product labelling, to become compliant.• Registration of all products with the competent authorities• Responsible for importations, coordination with Customs
  • Trn - Saúde E Cosmética Lda.
    Technical Responsible
    Trn - Saúde E Cosmética Lda. Oct 2005 - Sep 2007
    Porto, Portugal
    Responsible Person In charge of all legal and technical matters. Report to owners.Main Results and Projects• Elaboration of the documents required to obtain the license to open the store– direct contact with the competent authority.• Sending the list of products sold every month to the competent authority – legal requirement• Choosing the medications and negotiation suppliers to attain the best possible prices and conditions (payment terms), and making the weekly orders.• Training of staff to be able to correctly counsel the patients

Serafim Duarte Education Details

Frequently Asked Questions about Serafim Duarte

What company does Serafim Duarte work for?

Serafim Duarte works for Andreia Professional

What is Serafim Duarte's role at the current company?

Serafim Duarte's current role is Regulatory Affairs and Quality Assurance Director.

What is Serafim Duarte's email address?

Serafim Duarte's email address is se****@****ail.com

What schools did Serafim Duarte attend?

Serafim Duarte attended Faculdade De Farmácia Da Universidade Do Porto, Católica Porto Business School.

Who are Serafim Duarte's colleagues?

Serafim Duarte's colleagues are Andreia Sampaio, Sara Pinto, Paula Viviane, Joana Merêncio Teixeira, Carina Leite, Fábio Costa, Adriana Tomás.

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