Tiffany Nolan Email and Phone Number
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Senior Regulatory Affairs Specialist with 10+ years of experience in the pharmaceutical industry. Proven expertise in publication of FDA eCTD submissions, and technical writing. Skilled in managing regulatory processes, conducting document reviews, and ensuring compliance with FDA regulations leading to successful drug product approvals and launches. Strong analytical and problem-solving abilities with a commitment to delivering high-quality results while under pressure of tight deadlines. Seeking consulting opportunities to provide regulatory expertise and support to clients in the pharmaceutical industry. Key Skills: - FDA eCTD Publication - FDA Filing and Controlled Correspondence- Application Document Review - FDA Submissions (NDA, ANDA, IND, PADER, Annual Report, PAS, CBE, Promotional Labeling)- Expert proficiency in Lorenz docuBridge - Project Management - Safety Data Sheet Compilation- Technical Writing - System Integration and Administration- Systems Validation - Personnel Training
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Regulatory Support ConsultantLorenz Life Sciences GroupUnited States -
Regulatory Support ConsultantLorenz Life Sciences Group Apr 2024 - PresentFrankfurt, Hesse, De -
Senior Regulatory ConsultantAthenex Sep 2016 - May 2023Buffalo, New York, Us -
Senior Regulatory Affairs AssociateSagent Pharmaceuticals Apr 2013 - Mar 2016Schaumburg, Il, Us -
Consultant - Technical WriterIncworx Consulting Aug 2012 - Apr 2013Schaumburg, Il, Us -
Technical ConsultantIncworx Consulting Jan 2009 - Apr 2013Schaumburg, Il, Us -
Business Analyst & Technical WriterIncworx Consulting Mar 2010 - Jul 2012Schaumburg, Il, UsLong-term technical consulting engagement onsite at Sysmex America, Inc.- Constructed software validation documents for the corporate internal and external websites.- Managed the User Acceptance Testing phase of all web development.- Created training materials and conducted training and orientation presentations. - Built public-facing, multilingual SharePoint 2010 sites and web pages.- Created and maintained a Business Intelligence wiki on the SharePoint 2010 platform. - Coordinated project plans for a variety of overlapping projects.- Represented the PMO to ensure change control and consistent business practices across teams. - Completed testing scripts and plans to meet FDA requirements.- Provided software validation process knowledge of FDA CFR 21 Part 11 and Part 820.- Coordinated weekly website status review meetings between business application owners and development teams. -
Associate RecruiterIncworx Consulting Jan 2009 - Mar 2010Schaumburg, Il, UsIncWorx Consulting helps companies gain competitive advantage by delivering solutions that promote business agility. We are a premier Microsoft Managed Gold Partner and recognized as the leader in the primary areas of business productivity. With an emphasis on streamlining SAP by surrounding it with intuitive interfaces (office and forms), we have helped dozens of companies truly tap the potential of SAP to significantly increase worker productivity. With one of the highest customer satisfaction ratings amongst partners nationally, more companies are turning to IncWorx Consulting to solve their business challenges.With a global network of consultants, IncWorx seamlessly helps its customers anytime, anywhere. IncWorx consultants bring unparalleled technology and delivery expertise – a powerful combination for implementing technology visions that yield business results.Since our inception in 1998, we have helped 100’s of customers realize their business goals through technology coupled with our proven delivery methods. -
Partnered Staffing Supervisor For Jp Morgan ChaseKelly Services 2006 - 2008
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Customer Relations ManagerPulte Homes, Inc 2004 - 2006
Tiffany Nolan Skills
Tiffany Nolan Education Details
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Western Illinois UniversityCommunication
Frequently Asked Questions about Tiffany Nolan
What company does Tiffany Nolan work for?
Tiffany Nolan works for Lorenz Life Sciences Group
What is Tiffany Nolan's role at the current company?
Tiffany Nolan's current role is Regulatory Support Consultant.
What is Tiffany Nolan's email address?
Tiffany Nolan's email address is ti****@****ail.com
What is Tiffany Nolan's direct phone number?
Tiffany Nolan's direct phone number is +184790*****
What schools did Tiffany Nolan attend?
Tiffany Nolan attended Western Illinois University.
What skills is Tiffany Nolan known for?
Tiffany Nolan has skills like Sharepoint, Business Intelligence, Cross Functional Team Leadership, Business Analysis, Requirements Gathering, Leadership, Management, Project Management, Testing, Microsoft Office, Enterprise Architecture, Process Improvement.
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