Managed regulatory activities for assigned R&D projects (creams, inhalation and oral modified-release products) and related submissions.Coordinated the preparation of Chemistry, Manufacturing and Controls (CMC) documentation for international Clinical Trials and registrations (ASMF, DMF, IMPD, IND, MAA, CTD, Scientific Advice briefing packages reports, etc.) for in-house research products, with particular attention to ensuring they are prepared with adequate criteria and quality in their technical and regulatory aspects to be included in international dossiers.Participated in R&D Project Teams and other work groups with the objective of representing the regulatory opinions, providing general regulatory support and contributing the required CMC regulatory input into the clinical development, with particular attention to evaluating regulatory implications of proposed CMC changes and ensuring implementation of the regulatory requirements into product development plans.Contacted with and coordinated the different R&D and manufacturing departments in order to obtain the relevant information necessary for the preparation of CMC documentation.Defined strategy, managed and coordinated the resolution of Questions regarding new registrations.Attended meetings with Health Authorities (Scientific Advice), licensees, external companies, etc., required for the preparation of regulatory documents, or for the evaluation of new products.Evaluated, managed and answered queries concerning CMC aspects of development and registration received from the R&D Project Teams, referencing official Guidelines or checking with consultants.

Managed regulatory activities for assigned R&D projects (injectable and oral generic pharmaceutical products) and related submissions (MRP, DCP, National Procedures).Prepared documentation for international registrations (complete MAA dossier), clients and partners.Contacted with and coordinated the different R&D and manufacturing departments in order to obtain the relevant information necessary for the preparation of regulatory documentation.Defined strategy, managed and coordinated the resolution of Questions regarding new national and international registrations of generic pharmaceutical products.Provided scientific and regulatory support to the different R&D and manufacturing departments.

Managed regulatory activities for assigned R&D projects including a cream and an oral modified-release product.Provided support to the resolution of Questions regarding a new inhalation product registration.Provided scientific support, managed and coordinated the resolution of Questions regarding a new hard-capsule product registration.Collaborated with external consultants, partners and contract research organizations (CRO).

Managed regulatory activities for assigned projects (APIs and HAPIs for pharmaceutical products).Prepared, wrote and compiled regulatory CMC documentation for international registrations, variations, clients or partners (ASMF, DMF, JDMF, applications for CEP, etc.).Prepared the resolution of Questions regarding new applications;Reviewed information and documents from contributing departments to ensure compliance with regulations, Quality Agreements with clients or as agreed with partner organisations;Filed/archived the regulatory documents (electronically, DMS, paper) and maintained the regulatory databases (e.g. registration status).Provided scientific and regulatory support to the different R&D and manufacturing departments.

Researcher at the Medicinal Chemistry Department (R&D)Performed medicinal chemistry research of novel Central Nervous System active compounds.Designed, prepared and evaluated novel families of CNS potentially active compounds with favourable potency, physicochemical properties and safety profiles.Developed structure-activity relationships (SAR) of bioactive molecules.Proposed efficient synthetic strategies and wrote proposals for synthetic projects.Managed and coordinated synthetic projects performed in-house and/or by external collaborators (CROs).Created, managed and maintained up-to-date databases of the published data found on the literature.

Working in a collaborative project with UQUIFA.Developed a synthetic route for the preparation of a pharmaceutically active compound at the Catalan Institute of Chemical Research (ICIQ) for a pharmaceutical company (UQUIFA).Designed, conducted experiments, interpreted data independently and proposed synthetic solutions, optimised and scaled-up the synthetic route (identification of critical points, etc.).Purified and identified organic intermediate compounds and impurities.Organised and scheduled meetings, wrote the Project Reports and prepared oral presentations.

Post-doctoral researcher.Performed organic research into the optimization of organocatalytic asymmetric reactions.Co-directed research projects and supervised research of undergraduate students.Wrote and reviewed reports and scientific documents (journal articles, reviews, theses, patents, etc.).Collaborated with another international research groups.