Beatriz Nieves-López
Hollywood,FL
Summary
Knowledgeable Regulatory & Compliance Analyst skilled in developing and implementing frameworks and training programs to promote quality and regulatory compliance. Highly ethical and focused team player with productive, diligent approach. Bringing ten (10) years of experience in compliance and auditing.
Overview
1
1
Certification
13
13
years of professional experience
Work History
Regulatory & Compliance Consultant
Alternative Technical Solutions, LLC
03.2025 - Current
- Provide regulatory compliance support for manufacturing, pharmaceutical and medical device clients, ensuring adherence to applicable FDA regulations, quality standards, and industry requirements
- Conduct regulatory assessments, compliance reviews, and gap analyses to identify and mitigate risks
- Support the development, review, and maintenance of regulatory documentation, policies, procedures, and quality system records
- Develop compliance policies and procedures to align with regulatory standards.
- Execute thorough risk assessments to identify compliance gaps and recommend improvements.
- Collaborate with cross-functional teams to ensure compliance with regulatory requirements throughout product development and commercialization
- Monitor regulatory changes and provided guidance on compliance strategies and implementation
- Develop compliance policies and procedures to align with regulatory standards
- Conduct thorough risk assessments to identify compliance gaps and recommend improvements
Legal & Compliance Manager
Tri-Source Pharma, LLC
09.2023 - 03.2025
- Prepared, managed and submitted state and federal licensing applications, renewals, and re-credentialing for all subsidiaries
- Created, organized, and maintained internal licensing databases
- Monitored emerging regulations, standard updates, and policy changes to proactively address risk and drive internal compliance updates
- Drafted and managed regulatory communications, such as internal memos and responses to agency inquiries
- Conducted and assisted with internal and external audits and inspections
- Researched and interpreted state and federal compliance requirements for pharmaceutical wholesale distribution and manufacturing companies
- Interdepartmental collaboration leading to accurate maintenance of all records required to be kept, and preparation of required reports pursuant to federal and state laws and regulations
- Drafted, reviewed, and organized legal records, documents, correspondence, and communications
- Supported General Counsel with administrative duties, strategic initiatives and performed project-specific duties, including liaising with third parties, consultants, outside counsel, and regulatory agencies
Senior Regulatory & Compliance Manager (Domestic & Global)
SynergyLabs, LLC
09.2016 - 09.2023
- Authored and monitored complex technical documents and reports, including dossiers and comprehensive audit reports pursuant to cGMP, GDP, and regulatory guidelines
- Developed SOPs, compliance checklists, and scalable workflows to support internal training consistent with industry standards and regulatory requirements
- Created and effectuated internal audits program as part of continuous improvement plan
- Communicated with regulatory agencies to track submissions and monitor any changes to applicable regulations
- Integrated of scientific, technical, and legal knowledge to identify, assess risk, address issues, and conduct root-cause analysis to prevent recurrence (CAPA)
- Ensured submission, product, and facility compliance through regulatory strategy development
- Managed, coordinated, and collaborated on cross-functional projects for industry certifications (Green Seal, UL RCP, NASC)
- Tracked and interpreted federal and state-by-state legislation applicable to pet products, and provided appropriate insights and recommendations to senior leadership
- Conducted comprehensive regulatory assessments to determine how proposed initiatives may impact the overall operation
- Led regulatory compliance efforts to ensure brand/product compliance with FDA, APHIS, AAFCO, EPA, FTC, CPSC, Prop65, EPR, state-specific guidelines, and other applicable regulations and standards
- Collaborated with operations, legal, marketed, sales, and customer service departments to provide regulatory guidance and drive cross-functional regulatory alignment
- Reviewed and approved product labels and label extensions, packaging, website content, and marketing copy to ensure they meet federal, state compliance, and industry best practices
- Incorporated specialized legal skills such as contract management and negotiation, targeted legal research, and statutory interpretation into administrative duties to consciously balance current business needs with regulatory compliance requirements
- Created and implemented cost improvement compliance strategies based on risk assessment which allowed for scaling across functions and global markets
Maritime Regulatory & Compliance Analyst
SVITZER Salvage Americas Inc.
09.2013 - 09.2016
- Analyzed and interpreted U.S. and international maritime regulations to support compliance initiatives
- Developed and drafted detailed technical documents, regulatory reports, and operational guidance materials
- Conducted comprehensive reviews of internal and third-party documentation to ensure adherence to statutory and industry standards
Education
Juris Doctor - Law
Interamerican University of Puerto Rico
B.A. - Behavioral Science, Biology
University of Puerto Rico, Río Piedras
Skills
- Adept at legal research and compliance analysis
- Efficient project management
- Demonstrated expertise in contract drafting and negotiation
- Regulatory risk assessment and strategic mitigation planning
- Familiarity with contract lifecycle management systems (CLM)
- Working knowledge of ESG standards and supply chain risk management
- Fully bilingual (English and Spanish)
- Regulatory expertise
- Legal research
- Documentation review
- Compliance reporting
- Training delivery
Accomplishments
- Led regulatory inspections, submissions, and certifications which enabled a 3-million-dollar market expansion
- Collaborated with global regulatory agencies and prepared technical submission documents through drafting and translation, supporting market diversification that drove a 450% revenue growth over five years
- Designed and deployed a quality management framework compliant with cGMP and ISO 9001, and trained cross-functional teams to embed compliance requirements into day-to-day operations, standardize processes, and strengthen quality system adherence
- Earned ASQ Certified Quality Auditor (CQA) credential and led internal and external audits to identify compliance risks, ensure product traceability, and drive corrective and preventive actions
Certification
ASQ Quality Auditor
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Regulatory & Compliance Consultant
Alternative Technical Solutions, LLC
03.2025 - Current
Legal & Compliance Manager
Tri-Source Pharma, LLC
09.2023 - 03.2025
Senior Regulatory & Compliance Manager (Domestic & Global)
SynergyLabs, LLC
09.2016 - 09.2023
Maritime Regulatory & Compliance Analyst
SVITZER Salvage Americas Inc.
09.2013 - 09.2016
B.A. - Behavioral Science, Biology
University of Puerto Rico, Río Piedras
Juris Doctor - Law
Interamerican University of Puerto Rico