Serafim Duarte Email and Phone Number
Serafim Duarte personal email
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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.
Andreia Professional
View- Website:
- andreiaprofessional.com
- Employees:
- 39
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Regulatory Affairs And Quality Assurance DirectorAndreia ProfessionalPorto, Pt -
Regulatory Affairs & Quality Assurance DirectorAndreia Professional Nov 2001 - PresentMatosinhos, Porto, PortugalResponsible 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 -
Production ManagerAndreia Professional Dec 2003 - Dec 2012Gondomar, Porto, PortugalResponsible 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 -
Regulatory Specialist, Market Access And LabellingAndreia Professional Nov 2001 - Dec 2003Gondomar, Porto, PortugalResponsible 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. -
Technical ResponsibleHidow Europ Jan 2020 - PresentPortugalIn 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
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Technical ConsultantSmart Separations Ltd Jan 2021 - Jan 2022Braga, Braga, PortugalResponsible 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 -
Technical ManagerCann10 Portugal Jan 2016 - May 2020PortugalResponsible 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. -
Technical ResponsibleHummingbird Unipessoal Lda Apr 2013 - Jan 2019PortugalResponsible 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
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Technical ResponsibleTrn - Saúde E Cosmética Lda. Oct 2005 - Sep 2007Porto, PortugalResponsible 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
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Pharmaceutical Sciences -
Sustainability Studies
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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Serafim Duarte
Portugal -
1sapo.pt
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