Sandra Lourenço Email and Phone Number

- Mentor and develop team and team leads - Propose and negotiate project strategy to ensure the most feasible and cost-effective approach - Create regulatory strategy to support clients market access needs and support project execution. - Negotiations with the competent authorities - Liaising with Pharmacovigilance, Commercial, Marketing, and other departments, to align Regulatory department to company goals and expectations (technical and financial) - Deliver facilitating… Show more - Mentor and develop team and team leads - Propose and negotiate project strategy to ensure the most feasible and cost-effective approach - Create regulatory strategy to support clients market access needs and support project execution. - Negotiations with the competent authorities - Liaising with Pharmacovigilance, Commercial, Marketing, and other departments, to align Regulatory department to company goals and expectations (technical and financial) - Deliver facilitating and enabling solutions to add new business opportunities for current or future clients - Identify gaps and areas for improvement and lead remedial actions and initiatives - Lead the delivery of required services from the respective Regulatory partners and take remedial actions as needed - Ensure high-level delivery internally that adapts to company strategy and clients’ needs - Participate at industry events and trainings when required - Participate during any related business activities, i.e. meetings with clients, conferences, etc… - Executed projects during initial department growth Show less

- Mentor, coach and conduct regular performance evaluation with the teammembers;- Work cross-functionally and in collaboration with keystakeholders/customers;- Actively participate in scoping teams and proposal preparation;Actively participate in vendor process selection and evaluation;-Support company marketing initiatives;- Manage regulatory affairs designated projects;- Cooperate and communicate with the assigned Project Managers, clients andvendors… Show more - Mentor, coach and conduct regular performance evaluation with the teammembers;- Work cross-functionally and in collaboration with keystakeholders/customers;- Actively participate in scoping teams and proposal preparation;Actively participate in vendor process selection and evaluation;-Support company marketing initiatives;- Manage regulatory affairs designated projects;- Cooperate and communicate with the assigned Project Managers, clients andvendors representatives;- Liaison with international regulatory agencies as appropriate;- Develops and overview execution of regulatory strategy and accuratesubmission planning for designated project;- Provide solutions on complex regulatory issues;- Overview compilation/creation of registration dossier in the CTD, eCTD oranother format according to the current legislative requirements of the givencountry (eg. non-EU, RoW, etc..) for all types of processes - new registration,renewal, variations, etc…), as per clients need and request;- Overview timely submissions of regulatory applications;- Review of all documents prior submission or transfer to authorities/clients;- Overseas labelling up-dates;- Overview product life-cycle dossier management, according with projectgovernance;- Overview reporting, according with project governance settings; Overview archiving of all documents submitted to authorities and/or sent toclients;- Regular and accurate updating of internal or external reporting documents;- Active participation in assessment of impacts and risks resulting fromchanges in legislation;- Participation in audits;- Development, maintenance and improvement of the regulatory department system andprocedures; Show less

- Manage regulatory affairs designated projects; - Develops and execute regulatory strategy for the designated project;- Liaison with international regulatory agencies as appropriate;- Development of content and submission for complete and quality regulatory filings;- Work cross-functionally and in collaboration with key stakeholders/customers- Develop, Maintain and improve the regulatory department system and procedures.

Team and projects management.Regulatory affairs consultant and Experienced project manager on the following areas:- Human and Veterinary Medicinal products: MA Applications under different types of procedures (NPs, MRPs, DCPs and CP’s) in the EEA as well as Medicinal products registration in 3rd countries, e.g. outside the EEA) and legal basis, Variations and Renewals under the different types of procedures (NPs, MRPs, DCPs) in the different possible formats (CTD, NeeS, e-CTD… Show more Team and projects management.Regulatory affairs consultant and Experienced project manager on the following areas:- Human and Veterinary Medicinal products: MA Applications under different types of procedures (NPs, MRPs, DCPs and CP’s) in the EEA as well as Medicinal products registration in 3rd countries, e.g. outside the EEA) and legal basis, Variations and Renewals under the different types of procedures (NPs, MRPs, DCPs) in the different possible formats (CTD, NeeS, e-CTD, etc);- Extensive experience with the EU regulations and Guidance as well as in several 3rd countries;- Experience on regulatory advise and strategy for the development, registration and life-cycle management for products for EU and non-EU markets- Experience in CMC submissions;- Quality expert reports elaboration and revision;- Extensive gap-analysis of EU dossiers for future EU submissions assuring the dossiers accuracy and compliance with the legislation in force;- IMPD constitution and submission;- Experience with ANVISA submissions as well as with Swiss submissions;- Preparation, translation and revision of texts for SPC, PIL and Labelling;- Scientific Advices submssion;- Other Health Products life-cycle management experience (Cosmetics, biocides, medical devices and food suplements)- Importation and Exportation licences application submssion;- Training: Internal department collaboration;- External eCTD training;- Management of licensees, business partners, clients and Competent Authorities relationships. Show less

Team management; Active pharmaceutical ingredient (API) manager; responsible for EU-GMP audits compliance, new API’s qualification and post-MA variations management. Quality expert reports. IMPD constitution. Regulatory advice. Constitution, submission and management of new EU Marketing authorizations (MA) by National (EU and non-EU countries), Decentralised and Mutual Recognition procedures (CTD and eCTD format). Marketing authorisation maintenance activities: variations… Show more Team management; Active pharmaceutical ingredient (API) manager; responsible for EU-GMP audits compliance, new API’s qualification and post-MA variations management. Quality expert reports. IMPD constitution. Regulatory advice. Constitution, submission and management of new EU Marketing authorizations (MA) by National (EU and non-EU countries), Decentralised and Mutual Recognition procedures (CTD and eCTD format). Marketing authorisation maintenance activities: variations and renewals via National (EU), Mutual Recognition and Decentralised procedures.Post Marketing management including preparation, review, submission and monitoring of all types or variations (Type I and Type II).Management of licensees, business partners, clients and Competent Authorities relationships. Show less

Projects management. Quality expert reports. IMPD constitution. Regulatory support. Constitution, submission and management of new EU Marketing authorizations (MA) by National (EU and non-EU countries), Decentralised and Mutual Recognition procedures (CTD and eCTD format). Marketing authorisation maintenance activities: variations and renewals via National (EU), Mutual Recognition and Decentralised procedures. Post Marketing management including preparation, review… Show more Projects management. Quality expert reports. IMPD constitution. Regulatory support. Constitution, submission and management of new EU Marketing authorizations (MA) by National (EU and non-EU countries), Decentralised and Mutual Recognition procedures (CTD and eCTD format). Marketing authorisation maintenance activities: variations and renewals via National (EU), Mutual Recognition and Decentralised procedures. Post Marketing management including preparation, review, submission and monitoring of all types or variations (Type I and Type II). Show less

Analytical methodology development.Validation of analytical methodology for drug substances and drug products.Analytical pharmaceutical development of generics drug products.Constitution of regulatory documentation for the drug product MA submission.Good Manufacturing Practice and Validation.Drug analysis and Quality Control.

Methodologies experience: Current laboratory technics, HPLC, GC/MS, GC/FID, GC/olfactory, Flash Chromatography