Ashley Romao Email & Phone Number

Marlton, New Jersey, United States

- Developing/revising labeling for all new and existing products, while maintain compliance with US/EU.- Experience submitting with FDA eSTAR Program and DEKRA Certification. - Manages multiple product registrations and experience registration in new markets.- Create, revise and review package labeling and Instructions for Use (Clinical and Commercial)- Ability to communicate cross-functionally with Product Development, Quality Assurance, Clinical, and the Marketing/Field Team… Show more - Developing/revising labeling for all new and existing products, while maintain compliance with US/EU.- Experience submitting with FDA eSTAR Program and DEKRA Certification. - Manages multiple product registrations and experience registration in new markets.- Create, revise and review package labeling and Instructions for Use (Clinical and Commercial)- Ability to communicate cross-functionally with Product Development, Quality Assurance, Clinical, and the Marketing/Field Team to coordinate completion of tasks. - Manage the Instructions for Use e-copies that are available on Impulse Dynamics Website and perform bi-annual validation for all labeling.- Assist in managing translations required for global markets.- Maintain relationships with global partners, global regulatory bodies, and certification authorities.- Review clinical and commercial promotional material for distribution.- Manages Post Market Surveillance projects and yearly updates to documents in order to stay compliant with EU MDR and MDSAP regulations and guidelines.- Author / Revise documents within the Quality Management system (SOPs and Work Instructions).- Manages departmental administrative duties. Show less

Accumulation of 430,000+ followers7.8M+ likesEngage with audienceCollaborative work with other creatorsCollaborative work with sponsorsManage multiple projects at a timeCreate music covers and compose original musicSpeak on important topics relevant to world cultureParticipate in charity streamsView analytics and craft content around trends

Florham Park, New Jersey, United States

Complete cover letters, FDA Form 1571, FDA Form 356h, and other documentation for submission to FDA as needed.Support INDs and NDAs, including organizing the review process, preparing sections, reviewing for completeness, accuracy, and appropriateness. With managerial supervision, interpret and advise regarding regulations, key issues, risks, and other critical topics - interacting with interdisciplinary teams and other groups within and outside the organization to maxmize the business… Show more Complete cover letters, FDA Form 1571, FDA Form 356h, and other documentation for submission to FDA as needed.Support INDs and NDAs, including organizing the review process, preparing sections, reviewing for completeness, accuracy, and appropriateness. With managerial supervision, interpret and advise regarding regulations, key issues, risks, and other critical topics - interacting with interdisciplinary teams and other groups within and outside the organization to maxmize the business benefit and maintain regulatory compliance. Perform Quality Control reviews of regulatory issues. Establish contact with the FDA as required to support developmental programs. Ensure necessary clinical trial information is posted on clinicaltrials.gov, and that all listings are updated appropriately. Assist with creating and logging meeting minutes and study-start-up as needed.Adept in MS Word, Excel, Powerpoint, Adobe Acrobat, and Veeva Rim system. Show less

Princeton, New Jersey, United States

Provide advanced administrative support to a department or function, filing of documentation, etc. Responsible for database management including database entry.Perform all routine assignments with minimal to no supervision. Receives general instructions on new work that is reviewed upon completion.Provide regulatory support for Health Authority submissions including but not limited to proofreading documentation, importing document in the document management system, bookmarking and… Show more Provide advanced administrative support to a department or function, filing of documentation, etc. Responsible for database management including database entry.Perform all routine assignments with minimal to no supervision. Receives general instructions on new work that is reviewed upon completion.Provide regulatory support for Health Authority submissions including but not limited to proofreading documentation, importing document in the document management system, bookmarking and linking pdf documents, etc.Coordinates and prepares materials and presentations for the Executive's meetings, utilizing Microsoft Office Suite tools.Maintain files (including Iron Mountain), process accounts payables, and pre-pares/process executive travel expenses in conjunction with functional EA as needed. Ensure regulatory documentation systems fulfill functional excellence and quality goalsThe ability to be appropriately trained in Global Operating Procedures and Standard Operation Procedures of Sandoz and Pharmaceuticals in generalIntroduction to Good Document Management Introduction to regulatory affairs process and systemsLearning the FDA process for small molecules (Generic and Branded)Pharmaceutical experience in a cross-functional departmentLearning of the FDA requirements for labeling. Show less

Maintain a strong communityEntertain and engage with chatCollaborate with other creators on twitch and other platformsPut in 20 hours of streaming a weekEditing emotesVideo Editing and Clip highlightingAttend events and conventions to market a brand

Solved customer issues in person via telephone, resolved non-routine third party billings, patient problems, calculated dosage, stocked, and labeled medications, filled prescriptions, reviewed stock orders, helped pharmacist review and clear problematic prescriptions, managed over 50 calls a day, and received positive customer feedback on transactions and interactions.

Union, New Jersey, United States

Answered phone calls, greeting customers positively, managed office inventory, created and updated computer and physical records to maintain compliant documentation, organized efficient scheduling for both customer meetings and employee tasks.

Master'S Degree, Pharmacy Administration And Pharmacy Policy And Regulatory Affairs

Courses in: Drug Development, Good Laboratory Practices (GLPs), Food and Drug Law.

Bachelor'S Degree, Biology, General

Courses: Biology, Chemistry, Organic Chemistry, Biochemistry, Biostatistics.