Cycling, yoga, pilates, painting, photography, new recipes or cooking techniques, cultural exchange or getting to know new places, reading related to history and self-help, helping in dog and cat rescue and adoption days, editing and creating videos for social networks
Glenis Pinilla
Regulatory Affairs Associate
Panamá,Panamá
Summary
Regulatory Affairs Associate with 7 years of pharmaceutical industry experience. Demonstrates exceptional project management abilities in facilitation, organization, and time management. Skilled in providing regulatory leadership for new manufacturing development sites and change management activities. Known for dynamism, proactivity, and enthusiasm. Possesses a strong foundation in digital skills and a drive for professional development.
Overview
11
11
years of professional experience
5
5
years of post-secondary education
11
11
Certifications
1
1
Language
Work History
Regulatory Affairs Specialist
Johnson & Johnson
10.2023 - Current
- Participated in the advancement of new product lines, indications, and formulations.
- Updated compliance standards for product submissions across Central America and Caribbean regions.
- Prepared dossiers for product registration based on specific country requirements.
- Comply with local regulations in the registration process for all products.
- Ensured strict confidentiality of regulatory documentation.
- Approved promotional, marketing, and training materials.
- Facilitate creation of essential documentation for competitive bidding processes across multiple countries.
- Company representation in the pharmaceutical industry during communications with local regulatory agencies.
- Revised and approved mockups ensuring product specifications are met.
- Facilitated operations in departments including Planning, Supply, Marketing, and Sales.
- Updated regulatory status of products and disseminated information to different departments.
Regulatory Affairs Analyst
The Janssen Pharmaceutical Companies of Johnson & Johnson
03.2022 - 10.2023
- Assembled and processed documents for regulatory file submissions.
- Consolidated global information relevant to products and monitored submissions and approvals status.
- Prepared and maintained document inventory for core dossier preparation.
- Kept local and global databases current.
Regulatory Affairs Analyst
Lanco Medical Group
12.2018 - 03.2022
- Coordinated recall or market withdrawal activities as necessary.
- Prepared and submitted regulatory file applications and supporting documentation.
- Interpreted regulatory rules or rule changes and communicated with others through corporate policies and procedures.
- Implemented regulatory guidance procedures for commerial.
- Wrote or updated standard operating procedures, work instructions or policies.
- Evaluated data for adherence to regulations.
- Paid attention to detail while completing assignments.
- Participated in team projects, demonstrating an ability to work collaboratively and effectively.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Adaptable and proficient in learning new concepts quickly and efficiently.
- Excellent communication skills, both verbal and written.
Pharmacy Assistant
Your Pharmacy, Fast Medic, Farmacias Guadalupana
01.2015 - 06.2018
- Processed incoming drug orders by checking deliveries against paperwork and updating computer system.
- Performed safety checks when dispensing medications to optimize patient safety.
- Gathered and bagged prescriptions and prepared extemporaneous pharmaceuticals.
- Communicated instructions to patients or caregivers about proper use and storage of drugs.
- Assisted pharmacist by filling prescriptions for customers and responding to patient questions regarding prescription and medicationspecific issues.
- Prepared packaging and labels for prescriptions, verifying accuracy of dosage, side effects, interactions, and refill instructions.
- Located and measured medications according to prescription information, making modifications as instructed by pharmacists and providers.
- Distributed medicine and supplements from stock containers to correct packages.
Education
Bachelor's degree - Pharmacy
Universidad Latina de Panamá
Panamá 01.2015 - 12.2018
Postgraduate course - Regulatory Affaris LATAM
Escuela de Especialidades Farmacéuticas
Panamá 03.2022 - 12.2022
Diploma - Programa Internacional De Habilidades Gerenciales
Universidad Latina De Panamá
Panamá 05-2023
Skills
- Tools presentation
- Word Processors
- Spreadsheets
- Tableau
- SAP
- InSight
- Products in Data Processing
Certification
International Management Skills Program, Universidad Latina de Panamá, 06/2023
Additional Information
- Volunteering : Junior Achievement of Panama/Advisor in the DigiTal Girls programme.
Interests
Timeline
Regulatory Affairs Specialist
Johnson & Johnson
10.2023 - Current
Postgraduate course - Regulatory Affaris LATAM
Escuela de Especialidades Farmacéuticas
03.2022 - 12.2022
Regulatory Affairs Analyst
The Janssen Pharmaceutical Companies of Johnson & Johnson
03.2022 - 10.2023
Regulatory Affairs Analyst
Lanco Medical Group
12.2018 - 03.2022
Bachelor's degree - Pharmacy
Universidad Latina de Panamá
01.2015 - 12.2018
Pharmacy Assistant
Your Pharmacy, Fast Medic, Farmacias Guadalupana
01.2015 - 06.2018
Diploma - Programa Internacional De Habilidades Gerenciales
Universidad Latina De Panamá