Karen E. Sweeney
Bay Shore,NY
Summary
Regulatory Affairs Professional with over sixteen years’ experience in the preparation of regulatory submissions, supporting Project Leaders in formatting, organization, structuring and publishing of major regulatory submissions.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
5
5
years of professional experience
Work History
Regulatory Compliance Analyst
Haleon Inc.
06.2020 - Current
- Provided guidance to business units on the interpretation of regulations, ensuring consistent understanding and application across the organization.
- Prepared accurate and timely reports for senior management, highlighting key compliance issues and potential risks.
- Optimized operational efficiency by streamlining existing procedural workflows relating to regulatory reporting requirements.
- Supported the development of new products and services by assessing potential compliance risks and recommending appropriate controls.
- Created and maintained compliant work environment.
- Assessed fees related to registration of property-related documents.
Education
Medical Billing & EMR Certified -
Suffolk County Community College
Selden, NYCompleted coursework towards Liberal Arts -
Bronx Community College
Bronx, NYMicrosoft Office Suite, Certified -
Lehman College
Bronx, NYSkills
- Publisher
- Regulatory reporting
- Teamwork
- Teamwork and collaboration
- Problem-solving
- Attention to detail
- Problem-solving abilities
- Multitasking
- Reliability
- Organizational skills
- Adaptability and flexibility
- Documentation skills
- Task prioritization
- Self motivation
- Interpersonal skills
- Conflict resolution
- Training and development
- Operations management
- Document review
- Quality control
- Payment processing
- Records management
- SOP development
- Document control
Accomplishments
- Collaborated with team of 8 in the development of five ANDA Projects.
Professional Technical Expertise
- FDA Electronic Systems Gateway (ESG)
- CDER NextGen Portal
- eCTD Manager, eCTD build tools, Validator & Viewer
- i4i Structured Product Labeling (SPL)
- SharePoint
- Box
- Lorenz Docubridge
- Rosetta eCTD Viewer
- Veeva Vault
- MS Office tools
- Adobe Acrobat Professional
- ISI Toolbox
- Smartdesk
- GoogleMeet
Locations
- Suffolk County Community College, Selden, NY
- Bronx Community College, Bronx, NY
- Lehman College, Bronx, NY
Summary Of Experience
Regulatory Affairs Professional with over sixteen years’ experience in the preparation of regulatory submissions, supporting Project Leaders in formatting, organization, structuring and publishing of major regulatory submissions.
Timeline
Regulatory Compliance Analyst
Haleon Inc.
06.2020 - Current
Completed coursework towards Liberal Arts -
Bronx Community College
Microsoft Office Suite, Certified -
Lehman College
Medical Billing & EMR Certified -
Suffolk County Community College
Similar Profiles
Siva PerabathulaSiva Perabathula
Area Sales Executive at Haleon GlaxoSmithKlineArea Sales Executive at Haleon GlaxoSmithKline
David IkuaDavid Ikua
Pharmacy Key Accounts Manager & Sales Team Leader at Haleon Kenya Ltd / Spread Marketing Ltd.Pharmacy Key Accounts Manager & Sales Team Leader at Haleon Kenya Ltd / Spread Marketing Ltd.
Natalie M. Cortés MirandaNatalie M. Cortés Miranda
Manufacturing Operator GMP at HaleonManufacturing Operator GMP at Haleon