Angélica María Lozano Núñez
Bogotá D.C.,DC
Summary
Experienced Regulatory Affairs Manager with a 14-year track record in supporting compliance management. Collaborates effectively with cross-functional teams and consultants to minimize regulatory risk. Known for efficiently managing priorities and problem-solving to meet quick turnaround expectations.
Overview
17
17
years of professional experience
Work History
Technical and Regulatory Affairs Manager
Vesalius Pharma S.A.S.
02.2023 - Current
- Distinguished experience in the supervision and compliance of government regulations in the industry.
- Active participation in the successful implementation of regulatory strategies.
- Effective management of relations with government authorities and representatives of the sector.
- Supervision of technical teams in the application of regulatory regulations.
- Coordination of internal audits to ensure compliance with standards.
- Development of innovative strategies for the management of regulatory projects.
- Comprehensive analysis of changes in the legislation applicable to the sector.
- Establishment of rigorous protocols for the review of technical documents.
- Promotion of interdepartmental communication to align regulatory objectives.
- Leadership in training on regulations for technical staff.
- Preparation of precise technical reports for presentation to regulatory entities.
- Advice on the interpretation of complex regulations.
- Maintenance of updated technical documentation in accordance with regulatory changes.
- Implementation of regulatory risk management systems
Attention to queries related to technical and regulatory matters. - Supervision in the preparation of files for licenses and permits.
- Coordination of data collection for analysis of compliance.
- Proposal for process improvements to facilitate regulatory compliance.
- Performing activities associated with the Technical Management of the establishment.
- Supporting the processes of pharmaceutical product development and production with third parties.
- Inspection of raw materials, packaging materials and finished product to issue a released/approved/rejected concept.
- Self-motivated, with a strong sense of personal responsibility.
- Keep abreast of evolving industry trends, allowing the company to adapt quickly to changes in the regulatory landscape.
Regulatory Affairs Specialist
Caplin Point Laboratories Colombia SAS
12.2017 - 12.2022
- Coordinate the registration of pharmaceutical products.
- Prepare and review technical documents to approve new molecules.
- Maintain communication with regulatory entities to comply with regulations.
- Perform analysis of local and international regulations for development strategies.
- Participate in internal and external audits to ensure regulatory processes.
- Advise the development team on specific regulatory requirements.
- Manage delivery times for regulatory documentation.
- Monitor changes in legislation that affect the industry.
- Collaborate with quality teams to comply with regulations.
- Develop regulatory risk management strategies.
- Train staff in regulatory updates.
- Evaluate the viability of registrations in international markets.
- Supervise pharmacovigilance reports for health authorities.
- Follow up on changes in labels and packaging.
- Identify and propose improvements in documentation processes.
- Assist in defense strategies against regulatory inspections.
- Establish collaborative relationships with regulators.
- Implement a document management system to optimize times.
- Maintain detailed records of all regulatory activities, enabling quick access during inspections or audits.
Trainer and Regulatory Executive
Aculife Healthcare Private Limited
06.2015 - 11.2017
- Develop training programs that ensure regulatory compliance.
- Coordinate meetings to align regulatory objectives.
- Perform analysis of current regulations, identifying gaps in compliance.
- Implement continuous improvement strategies in regulatory processes.
- Establish a database for monitoring regulatory requirements.
- Facilitate training workshops on changes in regulations.
- Prepare regulatory reports aimed at senior management and competent authorities.
- Manage the relationship with regulatory bodies, ensuring effective communication.
- Provide technical support to teams in their relationships with regulatory entities.
- Supervise internal audits related to regulatory compliance.
- Collaborate in the creation of regulatory procedure manuals.
- Make presentations on the impact of regulations on the organization.
- Keep teams updated on trends and changes in the regulatory framework.
- Design educational materials for training on specific regulations.
- Drive a culture of compliance through awareness initiatives.
- Orient new employees, resulting in greater staff development and increased productivity.
Regulatory Affairs Analyst
Laboratorios Biopas
10.2014 - 03.2015
- Conduct regulatory analysis of regulations applicable to pharmaceutical products.
- Coordinate the preparation and submission of registration files to health authorities.
- Monitor legislative changes to ensure the company's regulatory compliance.
- Prepare reports on regulatory impact for senior management.
- Assist in regulatory audits, ensuring compliance with internal processes.
- Collaborate with multidisciplinary teams to develop regulatory strategies.
- Participate in the evaluation of risks associated with the introduction of new products.
- Formulate and update related internal procedures
- Train staff on current regulatory standards and procedures.
- Develop and maintain databases on international regulatory requirements.
- Implement deadline tracking systems for filing documents.
- Analyze adverse event reports and notify competent authorities.
- Collaborate in the development of defense strategies against possible regulatory sanctions.
- Perform internal audits to assess regulatory compliance in the company.
- Maintain a proactive approach to emerging regulatory changes in the sector.
- Coordinate the integration of new regulations into quality and production processes.
- Participate in conferences and seminars to stay up to date on regulatory trends.
- Promote a culture of compliance within the organization through workshops and training.
Regulatory Affairs Analyst
Coaspharma S.A.S.
03.2012 - 10.2014
- Develop and review regulatory documents for the pharmaceutical industry.
- Coordinate internal and external audits related to regulations.
- Analyze changes in regulations and their impact on the company's products.
- Interact with regulatory bodies to ensure regulatory compliance.
- Evaluate technical documentation submitted to obtain authorizations.
- Constant monitoring of legislative and regulatory updates in the sector.
- Train internal teams on regulatory compliance issues.
- Develop strategies for regulatory risk management.
- Participate in the preparation of technical and compliance reports.
- Assist in the preparation of presentations to regulatory entities.
- Review and update internal policies related to regulatory matters.
- Collaborate in research projects for compliance with current regulations.
- Analyze files for the validation of new products.
- Ensure alignment between business objectives and regulations.
- Collect and analyze data to improve regulatory processes.
Quality Assurance Inspector
Belcorp S.A.
06.2011 - 10.2011
- Conducting internal audits to ensure compliance with quality standards.
- Inspecting products at all stages of the production process.
- Analyzing deviations and non-conformities, with proposals for effective corrective actions.
- Preparing detailed quality reports and accurate audit reports.
- Training and educating staff on quality standards and established procedures.
- Collaborating with other departments to ensure compliance with quality standards.
- Rigorous evaluation of suppliers and materials according to their quality standards.
- Supervising physical and chemical tests in quality laboratories.
- Maintaining quality records and monitoring corrective actions implemented.
- Reviewing and validating technical documentation relevant to quality.
- Conducting thorough inspections of finished products before distribution.
- Active participation in multidisciplinary working groups aimed at continuous improvement projects.
Microbiology and Physicochemical Analyst - Quality
Boehringer Ingelheim
10.2007 - 08.2010
- Perform microbiological analysis on pharmaceutical products and raw materials, ensuring their quality.
- Perform physicochemical tests on compounds to ensure compliance with current regulations.
- Collaborate in internal audits to verify and maintain high quality standards.
- Update technical documentation of processes and procedures, optimizing their use.
- Participate in staff training in good laboratory practices, strengthening skills.
- Apply safety and biosecurity standards in the laboratory, prioritizing a safe environment.
- Evaluate and select raw material suppliers, ensuring the quality of inputs.
- Assist in the preparation of product stability studies, contributing to their effectiveness.
- Collaborate in the development of quality performance indicators, facilitating the measurement of results.
- Promote a culture of continuous improvement within the work team, promoting excellence.
Education
Bachelor of Science - Medicinal And Pharmaceutical Chemistry
Universidad De Ciencias Aplicadas Y Ambientales UDCA
Bogotá, Colombia12.2023
Technology in Pharmacy Regency - Pharmacy
Bogota Technology Corporation
Bogotá, Colombia12.2020
Technology in Industrial Chemistry - Chemistry
SENA Centro Nacional Minero
Sogamoso, Colombia04.2008
Skills
- Labeling compliance
- Regulatory strategy
- Regulatory submissions
- Global regulatory compliance
- Medical device regulations
- Regulatory policies
- Document management
- Regulatory agency applications
- Risk management
- Audits
- Inspections
- International regulations
- Change control
- Product lifecycle management
- Requests for information
- Technical writing
- Product information
- Pharmaceutical industry
- Post-market surveillance
- License renewals
- Cross-functional team leadership
- Regulation compliance
- Regulatory strategy development
- Teamwork
- Teamwork and collaboration
- Problem-solving
- Time management
- Attention to detail
- Leadership skills
- Problem-solving abilities
- Multitasking
- Multitasking ability
Languages
Español
Bilingual or Proficient (C2)
Inglés
Elementary (A2)
Research and read global regulatory update texts.
I like to stay informed about changes in regulatory standards, especially in Latin America. However, I like to learn about FDA and EMA regulations and I subscribe to several pages to stay up to date with developments.
I also like to travel with my family and accompany my son to his hockey games every weekend. I am excited to watch him play and grow as an athlete and person.
Timeline
Technical and Regulatory Affairs Manager
Vesalius Pharma S.A.S.
02.2023 - Current
Regulatory Affairs Specialist
Caplin Point Laboratories Colombia SAS
12.2017 - 12.2022
Trainer and Regulatory Executive
Aculife Healthcare Private Limited
06.2015 - 11.2017
Regulatory Affairs Analyst
Laboratorios Biopas
10.2014 - 03.2015
Regulatory Affairs Analyst
Coaspharma S.A.S.
03.2012 - 10.2014
Quality Assurance Inspector
Belcorp S.A.
06.2011 - 10.2011
Microbiology and Physicochemical Analyst - Quality
Boehringer Ingelheim
10.2007 - 08.2010
Bachelor of Science - Medicinal And Pharmaceutical Chemistry
Universidad De Ciencias Aplicadas Y Ambientales UDCA
Technology in Pharmacy Regency - Pharmacy
Bogota Technology Corporation
Technology in Industrial Chemistry - Chemistry
SENA Centro Nacional Minero
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