Jason Alba, Mba/Dba

Jason Alba, Mba/Dba Email and Phone Number

Advisory Board Member | Pharmaceutical & Biotechnology Regulatory Affairs | Regulatory Operations | Clinical Trials | Medical Device Manufacturing | Compliance | Clinic @ Networked
Jason Alba, Mba/Dba's Location
San Diego County, California, United States, United States
Jason Alba, Mba/Dba's Contact Details
About Jason Alba, Mba/Dba

Seasoned Pharmaceutical Regulatory Operations Leader with over 20 years’ experience driving the evolution of the drug development process.⇨ Advances biotech products from early indication activity through launch and commercialization by managing cross-functional regulatory submission process. ⇨ Energetic and results-focused strategist who interacts across regulatory compliance departments, clinical studies, clients, and executive teams.⇨ Process-driven technologist who leverages software to achieve efficiencies and drive progress from Theory in the Lab to Proof in the Lab to market.⇨ Highly team-focused leader who empowers people, leans in for clarity, and navigates through ambiguous goals to refine processes and efficiencies.KEY DRIVERS:📌 Energetic, make-it-happen mindset📌 Bias for collaboration📌 Empowers teams📌 Process driven📌 Relationship building📌 Navigates ambiguityAREAS OF EXPERTISE:✓ Team Building ✓ Biotech Product Development✓ Project Management✓ Labeling✓ Training✓ Manufacturing Process✓ Medical Device✓ BiotechnologyTECHNICAL SKILLS: • MS Office (Word, Excel PowerPoint, Outlook, Visio, MS Project), SharePoint (Admin), Adobe Professional • EDM: Documentum, FirstDoc, ARCH, D2• Submission tool/products – Lorenz eBal, EURs, Liquent Suite, ISIToolBox• Databases: FileMaker Pro (Admin Level), Access (Admin Level)• LIQUENT Insight (integrated Regulatory Information Management platform) Manager Global Regulatory Submissions | Revenue Growth | Strategic Planning | Solution Architect | Project Management | Cross-functional Team Leadership | OQ Testing | Marketing | Publishing | Product Presentations | Electronic Systems Development | Process Change ManagementVendor Relations | Global Communication

Jason Alba, Mba/Dba's Current Company Details
Networked

Networked

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Advisory Board Member | Pharmaceutical & Biotechnology Regulatory Affairs | Regulatory Operations | Clinical Trials | Medical Device Manufacturing | Compliance | Clinic
Jason Alba, Mba/Dba Work Experience Details
  • Networked
    Appointed Healthcare Advisory Board Member
    Networked Oct 2024 - Present
    Philadelphia, Pa, Us
    I'm actively contributing to Network.CO's growth in the healthcare sector. This board's mission is to craft and implement go-to-market strategies for successful market entry within the next 1-3 years. As a Senior Advisory Board Member, I’ll play a key role with the team in driving innovation, fostering high-performing teams, and supporting sustainable company growth. Responsibilities:*Corporate Development: Developing strategic plans and go-to-market strategies.*Product-Market Fit: Validating product offerings and identifying target markets.*Exponential Growth: Scaling operations and achieving rapid growth.*Team Building: Cultivating a positive and collaborative work environment.*Competitive Advantage: Identifying and overcoming market challenges.*Fundraising: Securing funding to support company growth.
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  • Esteem Health Services
    Appointed Esteem Health Services Advisor
    Esteem Health Services Mar 2024 - Present
    Advisory Board: Esteem Health is a psychiatric pediatric social, emotional, mental, and behavioral health technology driven hybrid clinic that specializes in helping low-income, underserved families navigate challenges from preschool through high school. *Responsibilities include: Provide advice and participate in planning and strategy sessions to help the company achieve goals and objectives.* Special Projects
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  • Guidepoint Advisors
    Guidepoint Advisor
    Guidepoint Advisors Sep 2023 - Present
    As a Guidepoint Advisor I help you navigate a new level of understanding. With an ever-evolving network of valued business executives, renowned thought leaders and verified subject-matter experts that spans industries, disciplines and borders, we connect those seeking even the most specific type of wisdom with those uniquely qualified to provide it. Focus in Life Sciences, Healthcare Information Technology-Information Technology Consulting: Large and small firms.
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  • Cognizant
    Associate Director - Projects: Health Life Sciences
    Cognizant 2017 - Nov 2023
    Teaneck, New Jersey, Us
    Hired as strategic leader to oversee operational interactions and enhance efficiencies for the Regulatory Affairs Operations team of aesthetics and medical device manufacturer. Collaborate with stakeholders and cross-functional teams in support of regulatory operations. Oversee operational interactions and improve efficiencies for the Regulatory Affairs team.• Enabled continuing operations of manufacturing process during major platform migration by managing mitigation of regulatory issues during migration.• Developed strategies to effectively resolve emerging issues by conducting root cause analysis, asking the right questions, and facilitating collaboration across teams throughout troubleshooting process to eliminate duplicate efforts and increase accuracy.• Managed complex sequences of activity to manage regulatory compliance of hundreds of products with thousands of filings. • Positioned as trusted advisor with client and internal teams; break down silos, foster collaboration, and provide key guidance and resources to enable team success.• Increased revenue and work efficiency by streamlining processes, communication, training effectiveness, testing, workflow management, and insight of implementation.
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  • Wipro Limited
    Senior Domain Consultant – Regulatory & Compliance, Healthcare & Life Sciences
    Wipro Limited 2014 - 2017
    Bangalore, Karnataka, In
    Senior Domain Consultant – Regulatory & Compliance, Healthcare & Life Sciences Recruited as Business Systems Consultant with mandate to expand contracts with client (Allergan). Oversaw regulatory affairs operations and clinical safety engagements throughout publishing process.• Charted strategy to scale services and cultivated lead pipeline by capturing analytics on high-potential leads.• Project managed upgrades of submission tools, advising on best practices for process improvement impacting regulatory users; platform included major vendor applications for label development and third-party submission tools.• Supported global teams’ eCTD submissions.
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  • Allergan
    Regulatory Analyst, Global Regulatory Affairs
    Allergan 2012 - 2013
    Dublin, Coolock, Ie
    Regulatory Analyst, Global Regulatory Affairs Contracted through Adecco to improve Allergan internal processes by evaluating internal process and leading project management of submission-tracking tool affecting cross-functional roles. • Improved efficiency by launching 3 key projects which became adopted as standard operating procedures.o International Registration Filings (IRF) | Collaborated with cross-functional team both in US and international. o eCTD Template Tool | Managed testing and evaluation of process to facilitate a smooth transition in software usability for submission content development.o Template Submission Evaluation and testing.• Evaluated gaps and improved overall workflow process by leading implementation of improved submissions tracking tool.
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  • Amgen
    Regulatory Project Manager
    Amgen 2009 - 2011
    Thousand Oaks, Ca, Us
    Administered product/program work-stream deliverables with global representatives (Canada, Australia, UK & Japan). Orchestrated global meetings/ webinars, communicating plan of actions, slippage, bridging gaps when activities fell below the baseline of an activity goals. Coached Global Leaders and their managers in dealing effectively with product teams and goals. Presented metrics to regulatory members and corporate product leaders on a monthly basis.• Developed department enterprise template timelines and team to link to top-tier corporate Project Management• Conducted pilot programs template timelines and reporting to increase efficiency for meeting corporate and department goals• Developed roadmap for training and execution of preparing for FDA meetings: Internal logistics, Mock Meetings, Consultant contract interactions, communicating to a wide audience both team and executive management• Coached cross-functional members to develop presentations for health agency meetings• Support multiple teams on Communication of activities on respective products/programs, updates to Timelines, cross-functional interactions on a monthly basis• Developed metrics tracker for key team meetings (GRT’s) Global Regulatory Teams, decreasing communication and action time• Updated regulatory business operations database tracking submission timelines, manage author handoff times, Regulatory Insight Manager Tracking applications for submissions and reportingo Interactions with Product teams and scheduled dossier filingso Report publishing of tracked submissions to Research and Development Project Managemento Improved efficiency by developing metrics tracker for key team meetings.
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  • Amgen
    Information Management
    Amgen 2007 - 2009
    Thousand Oaks, Ca, Us
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  • Amgen
    Publisher / Labeling
    Amgen 2000 - 2007
    Thousand Oaks, Ca, Us
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  • Baxter International Inc.
    Advertising & Labeling Promotion | Info Management Specialist | Regulatory Clerk | Manufacturing
    Baxter International Inc. 1997 - 1999
    Deerfield, Illinois, Us
    • Advanced from the ground floor of production in fractionation through progressive roles in regulatory affairs.• Promoted successively to create new roles, requiring understanding of drug development, regulations, and labeling.• Awarded recognition for completing the first FDA electronic submission for Baxter. • Pioneered a first-in-kind Proof of Concept, an interactive Table of Context now widely used across the industry.
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Jason Alba, Mba/Dba Skills

Pharmaceutical Industry Fda Cross Functional Team Leadership Clinical Trials Regulatory Affairs Biotechnology Project Management Program Management Management Leadership Oncology Change Management Training Regulatory Submissions Team Building Process Improvement Business Analysis Strategic Planning 21 Cfr Part 11 Life Sciences Validation Testing Vendor Management Software Documentation Sop Project Planning Business Strategy Business Process Improvement Competitive Analysis Databases Data Analysis Strategic Communications Communication U.s. Food And Drug Administration

Jason Alba, Mba/Dba Education Details

  • Rushmore University
    Rushmore University
    Operations
  • Rushmore University
    Rushmore University
    Entrepreneurship/Entrepreneurial Studies
  • Pasadena City College
    Pasadena City College
    B. S. Bachelors Of Fire Science

Frequently Asked Questions about Jason Alba, Mba/Dba

What company does Jason Alba, Mba/Dba work for?

Jason Alba, Mba/Dba works for Networked

What is Jason Alba, Mba/Dba's role at the current company?

Jason Alba, Mba/Dba's current role is Advisory Board Member | Pharmaceutical & Biotechnology Regulatory Affairs | Regulatory Operations | Clinical Trials | Medical Device Manufacturing | Compliance | Clinic.

What is Jason Alba, Mba/Dba's email address?

Jason Alba, Mba/Dba's email address is ja****@****hoo.com

What schools did Jason Alba, Mba/Dba attend?

Jason Alba, Mba/Dba attended Rushmore University, Rushmore University, Pasadena City College.

What are some of Jason Alba, Mba/Dba's interests?

Jason Alba, Mba/Dba has interest in Pivoting Skill Set To New Challenges, New Technology, Snow Skiing, Scuba Diving, Process Improvement.

What skills is Jason Alba, Mba/Dba known for?

Jason Alba, Mba/Dba has skills like Pharmaceutical Industry, Fda, Cross Functional Team Leadership, Clinical Trials, Regulatory Affairs, Biotechnology, Project Management, Program Management, Management, Leadership, Oncology, Change Management.

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