Detailed Information

11/2022-AstraZeneca Rare diseases

Global Regulatory Affairs Manager

• Responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
• Provide operational and strategic regulatory input to cross-functional teams responsible for global programs and ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.
• Serve as regulatory strategy lead within EU/designated region(s) on assigned program. May serve as global regulatory team leader on assigned programs.
• Develop and direct innovative and effective regulatory strategies in support of assigned AZ portfolio, pipeline and therapeutic areas.
• Provide advice on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues within AZ (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).
• Prepare and execute region-specific aspects of regulatory affairs and ensure integration into global regulatory strategy.
• Represent AZ as point of contact with regulatory authorities, including providing support for and coordination of regulatory meetings and information package development.
• Coordinate submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial application submissions, amendments, etc.
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
• Ensure exemplary behavior, ethics, and transparency within the company and with regulatory agencies.

11/2020-11/2022 Glenmark Pharmaceuticals, Europe

Regulatory Affairs Manager

• Successfully interact with the project and functional teams in Europe & India to ensure that data generated is appropriate and will be presented and compiled in accordance with EU requirements.
• Provide support and guidance to the Global RegulatoryAffairs EU team when evaluating new projects as part of the European Portfolio Meeting (EPM) process and Product Portfolio Meeting (PPM) process, by providing national regulatory insight and opinion on risks.
• Direct communication with regulatory authorities to facilitate productive dialogue on all new and existing product submissions and other relevant issues (works with other departments globally for submission plan and timing).
• Timely preparation and submission of regulatory applications (generally DCP, MRP, CP or national submissions) including responses to requests for further information from Competent Authorities, managing the national phase in Spain to get MA following closure of the European Regulatory Procedures.
• Post-approval activities including maintenance of approved MAs, Renewal applications and launch activities (AWs review).
• Assistance in compilation of compliance files for new license approvals and updating compliance files during life cycle of the product where necessary
• Liase with external companies with respect to in-licensing activities and any associated regulatory issues as required.
• Being as primary contact with Health Authorities (HA)(including the Ministry of Health) and leads the preparation of dossier content according to the strategic plan for each country and determines timing and content of the global strategy.
• Defines, generates, submit and ensure that appropriate responses to Health Authority questions are handled in a timely manner and in line with the approved product strategy.
• Modify submission plan and align with sourcing, IP and launch strategies.
• Monitor and informs on emerging trends, regulations and changes, will emphasis on those related to area an region of responsibility.
• Provide direction to senior leadership, as relevant and also team members.
• Lead and provide regional regulatory input in due diligence for licensing opportunities, development and / or marketed products.
• Management of all activities involved in the access of a medicinal product in the Spanish market
• Acting as the backup for the local Qualified person for Pharmacovigilance, ensuring all relevant PV activities are in compliance with local regulations and managing Adverse Event as required.
• Collaborating closely with local and international colleagues from other departments such as Marketing, Medical, Regulatory in the Global Brand plan, to ensure alignment on market access strategy.

03/2016-11/2020 Pharmalex Spain, Alcobendas (Madrid), Spain

Head of Team and Manager Regulatory Affairs & Market Access

• Work with the clinical team to develop clinical trial submission plans and preparation and review of the documentation needed for the submission of the CT application to get the EudraCT number.
• Ensure that the protocol and all documentation required is alligned with the regulatory requirements in each country.
• Participate in Scientific Advise meetings for the submission of a medicinal product through a Centralised Procedure and manage the local notifications for CP procedures.
• Updating proposed Company Core Data Sheet (CCDS) and global labels, based on the target label from the clinical part for the submission along with the dossier.
• Negotiates regional labeling with HAs, through the different EU & UK procedures registration.
• Marketing authorization application, variations and renewal submissions to the Health Authorities for Medicinal Products in Asia, Latin America, Africa, Middle East & Russia.
• Preparation of the submission packages in eCTD, Nees & ASEAN formats and answer to questions from Health Authorities (deficiency letters).
• Review and management of the validation of a registration dossier (from Module 1 to Module 5) to obtain the Marketing Authorization through CP procedures as well as MRP/DCP Procedures and National Procedures in Europe and manage the National Phases in all EU countries to get the MA.
• Preparation, submission and follow-up of variation type IA, IB, II, renewals of MA, notification of article 61 (3) as well as submission of Local Representative and Marketing Authorization Holder variations (post-marketing activities) as well as the review and approve of mockups/AWs/Print proof materials.
• Plan, author and manage the assembly and timely submission of CMC related sections MAAs, post approval, renewal, line extensions and other dossiers to meet filing requirements as well as clinical and non-clinical documents for submission.
• Responsible for the regulatory evaluation of CMC change controls and clinical changes and maintaining product compliance troughout the product lifecycle.
• Drive Regulatory Team to meet global and regional standard and meet agreed timelines (e.g timely safety submission, high quality translations, artwork, pharmaceutical documentation compliance) and lead it to ensure agreed objectives and main responsibilities are met according to agreed timelines.
• Ensuring the compliance of the GDPs and acting as contact person with local Health Authorities (including the Ministry of Health).
• Collaboration with the MAH in the preparation of the IPTs and support it in all Market Access activities.
• Acting as Local Pharmacovigilance responsible for a client (reviewing PV guidelines and literature, creating PV SOPs and managing adverse events received in Spain).
• Acting as Technical Director for a client after getting the approval of a company as MAH in Spain (support the client in all activities required as creation of SOPs, quality manual and the inspection by the authority).

10/2013-02/2016 Laboratorios Aurobindo S.L.U. , Madrid, Spain

Regulatory Affairs Technician

• Submission and follow-up of medicinal products registration through National, Decentralised, Mutual Recognition and Centralised Procedure to obtain the marketing authorization.
• XEVMPD management.
• Submission and follow-up of variation type IA, IB & II variations as well as notifications of article 61 (3) for human medicinal products.
• Submission and follow-up of Local Representative and Marketing Authorization Holder transference variations.
• Complete management of applications for communication to Health Authorities like Raefar, CESP, etc.
• Conversion of sequence from Nees to eCTD and compilation in eCTD program.
• Complete management of national phases in Spain obtaining the authorization.

07/2008-10/2013 Trinity Solutions, Madrid, Spain

Regulatory Affairs Technician

• Regulatory and Quality Consulting for the Pharmaceutical Industry.
• Regulatory dossiers development of drug products.
• Variations of drug products on Nees & eCTD format.
• Management of Raefar application.
• Readability tests of package leaflet.
• SPC and PIL translations (English to Spanish & Spanish to English).
• Technical memories of Laboratories.
• Cosmetic and medical devices report.
• Application of National Code to Food Supplements for their commercialization