Master of Science in Jurisprudence @
Seton Hall University School of Law
Regulatory Affairs professional with a record of success in delivering expertise needed to accomplish team goals. Demonstrated ability to influence outcomes while partnering with marketing, legal, medical, and other cross-functional colleagues, so as to drive projects while mitigating risk and maintaining compliance with FDA regulations. Substantial experience in steering team meetings. Key areas: advertising and promotion, labeling,
Regulatory Affairs professional with a record of success in delivering expertise needed to accomplish team goals. Demonstrated ability to influence outcomes while partnering with marketing, legal, medical, and other cross-functional colleagues, so as to drive projects while mitigating risk and maintaining compliance with FDA regulations. Substantial experience in steering team meetings. Key areas: advertising and promotion, labeling, clinical trials.
Associate Program Director @ Commercial Regulatory Affairs (CORA) From July 2015 to Present (6 months) Senior Specialist, Advertising and Promotional Compliance, Regulatory Affairs @ • Independently review and approve promotional marketing material for prescription and over-the-counter drugs and assist in the review of marketing material for medical devices
• Successfully provide regulatory strategic guidance for the development and execution of marketing promotional material for Allergan’s biggest franchises: BOTOX therapeutic across multiple indications and in Eye Care therapeutics such as LUMIGAN (glaucoma), REFRESH (dry eye), OZURDEX (retina) and LASTACAFT (allergy)
• Productively represent regulatory and steer cross-functional review committee meetings composed of marketing, ad agencies, legal, and medical
• Created best practices documents for the usage of different types of data to support claims, such as substantial evidence criteria (for efficacy claims) and prescription and formulary data
• Established a process with marketing and labeling for the implementation of label changes into promotional material to meet regulatory requirements and commercial needs
• Trained summer intern on reviewing promotional pieces and mentored him on his assigned projects
• Appointed to assist in the review of Pre Market Authorization devices: NATRELLE (breast implants) and JUVEDERM (filler)
• Implemented department training to educate on the different classes of medical devices (class I,II, III) and on the different regulatory approval pathways such as 510(k) and PMA From July 2012 to 2015 (3 years) Senior Associate, Regulatory Affairs @ 1) Provide regulatory support to the Upper Respiratory Business Franchise in its new product global development program:
۰ Represent Regulatory Affairs in cross-functional teams developing INDs, NDAs, and global dossiers.
۰ Represent Regulatory Affairs in marketing claims development efforts.
2) Primary regulatory lead responsible for development programs of Afrin, Coricidin HBP, and Chlor-Trimeton brands:
۰ Key member of cross-functional teams working on developing product claims for labeling and promotion / advertising, as well as commercialization of products and line extentions.
۰ Maintain US dossiers and prepare cyclical reports (Annual and Adverse Drug Event reports). From June 2011 to June 2012 (1 year 1 month) Regulatory Affairs Associate @ Review and approve advertising and labeling material of Schering-Plough's OTC brands, as per FTC regulations and FDA's NDA and monograph systems.
Responsible person for submission of Annual Reports and Adverse Drug Event Reports (ADE) to the FDA, in maintenance of INDs and NDAs. Brands: MiraLAX, Afrin, Gyne-Lotrimin and Correctol.
US Regulatory Affairs contact on international matters related to claims on OTC product packaging. From November 2008 to June 2011 (2 years 8 months) Clinical Trials Coordinator @ From February 2007 to November 2008 (1 year 10 months) Sr. Clinical Information Specialist @ From September 2003 to February 2007 (3 years 6 months)
Bachelor’s Degree, Biology and Society @ Cornell UniversityMaster of Science in Jurisprudence, Health Law, Intellectual Property @ Seton Hall University School of LawHigh School @ Academy for the Advancement of Science and Technology Michal Sienko is skilled in: Regulatory Affairs, Cross-functional Team Leadership, Biotechnology, Clinical Trials, FDA, Pharmaceutical Industry
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