Alexander Santa Cruz
Garfield,NJ
Summary
Regulatory Affairs professional with more than twelve years of comprehensive experience overseeing all aspects of regulatory affairs and compliance. Hardworking and versatile individual well-versed in executing business strategies, preparing and implementing business plans, and evaluating organizational practices to drive changes. Knowledgeable about beauty, personal care, OTC, among other consumer goods products. practices, and regulations. Attentive and exacting with demonstrated success in handling domestic and international regulatory needs for diverse products. Systematic and practical with sound judgment, an analytical mindset, and good problem-solving skills.
Overview
14
14
years of professional experience
Work History
Regulatory Affairs Consultant
Self Employed Services
08.2023 - Current
- Supported diverse areas of regulatory responsibility for contracted clients.
- Evaluated existing processes within the organization against current good manufacturing practices requirements.
- Authored detailed reports summarizing findings from literature review projects related to global regulatory affairs topics.
- Answered consumer inquiries with friendly and knowledgeable support.
Regional East Coast Director, Regulatory Affairs
KDC/One Group
Saddle Brook, NJ
01.2021 - 04.2023
- Oversaw Regulatory Affairs functions and developed strategies to ensure compliance with regulations for cosmetics, personal care, and OTC products manufactured for contracted brands
- Led a team of six Regulatory Affairs professionals and one Raw Material Compliance professional
- Developed and supported new procedures for key regulatory processes to ensure the highest level of compliance
- Proved analytical knowledge of existing and emerging domestic and international regulations to support our 60+ prestige contract brands marketed globally
- Maintained open communication with team members and stakeholders, resulting in successful project outcomes.
- Worked with regulatory authorities such as FDA, EPA, CPSC, EU Cosmetics Directive, ECHA, and Health Canada
- Supported efficacy and toxicology product testing.
Regulatory Affairs Manager
Grant Industries, Inc.
Elmwood Park, NJ
09.2019 - 01.2021
- Managed the submission process of new products or changes to existing products through the appropriate national health authorities.
- Offered comprehensive and detailed regulatory aid to all company divisions
- Served as the key point of contact for domestic and international clients
- Prepared technical documentation packages for registration purposes worldwide.
- Established professional connections with customers across different regions.
- Participated in international conferences related to current issues in Regulatory Affairs.
Regulatory Affairs Specialist
MANA Products, Inc.
Long Island City, NY
07.2016 - 09.2019
- Oversaw regulatory compliance of more than 24 contracted customers and in-house brands
- Managed regulatory change required by new and revised laws and regulations, communicating complex requirements and identifying operational impacts.
- Assisted in the preparation of technical documentation for registration submissions.
- Crafted regulatory documents and managed product testing timelines.
- Collaborated with a cross-functional team to define features and build powerful and easy-to-use products and customer-facing workflow tools.
Regulatory Raw Material Specialist
Naturex, Inc.
South Hackensack, NJ
07.2010 - 09.2016
- Provided clients with essential regulatory and quality documents
- Collaborated with various departments to ensure compliance
- Prepared and completed regulatory documents for raw materials
- Participated in meetings for inventory requirements and strategic planning.
Education
B.A. in Science -
Fairleigh Dickinson University
05.2007
Skills
- Product Lifecycle Management
- Regulation Compliance
- FDA Regulations
- Technical Documentation
- International Regulations
- Product Information
- Regulatory Submissions
- Product Labeling
- Document Control
- Consumer Inquiry Management
- Good Manufacturing Practices
- PowerPoint
- Optiva
- Ithos
- USMCA certificates
Activities
NYSCC Member & Supplier’s Day/Education Awards Night Volunteer
Languages
- English
- Spanish
Languages
English
Professional
Spanish
Professional
Timeline
Regulatory Affairs Consultant
Self Employed Services
08.2023 - Current
Regional East Coast Director, Regulatory Affairs
KDC/One Group
01.2021 - 04.2023
Regulatory Affairs Manager
Grant Industries, Inc.
09.2019 - 01.2021
Regulatory Affairs Specialist
MANA Products, Inc.
07.2016 - 09.2019
Regulatory Raw Material Specialist
Naturex, Inc.
07.2010 - 09.2016
B.A. in Science -
Fairleigh Dickinson University