Emerging markets CMC - Asia Pacific lead

Developed strategy and led preparation of the CMC sections of initial US/EU/MOW marketing applications of Quality by Design (QbD) filings for multiple therapeutic franchises. • Prepared CMC background packages in support of questions to Agencies regarding CMC filing strategies • Provided CMC support during Pre-Approval Inspections of manufacturing sites for new product filings • Authored technically sound responses to Agency review questions and represented CMC in associated Agency teleconferences• Core member of several new product cross functional product development teams (IDST)• Reviewed numerous NDAs as a CMC subject matter expert of strategic and technical content.• Led Regulatory Working Group meetings and attended Global Regulatory Team meetings as the key interface between the IDST and Regulatory Affairs • Developed and implemented regulatory strategies for new product filings and post-approval changes including the identification of potential risks and mitigation plans • Key member of a team responsible for developing a Launch Supply Strategy which incorporates marketing, regulatory, CMC and supply chain requirements into a worldwide filing/launch plan• Responsible for high level scoping of major franchise initiatives and development of innovative worldwide regulatory filing strategies • Performed CMC due diligence for several potential in-license compounds • Served as a subject matter expert of the regulatory approval tracking database • Acted as the CMC regulatory liaison to the Chinese subsidiary to address regulatory and CMC issues specific to China • Prepared initial IND/CSA filings, amendments, and agency responses in support of clinical programs through all stages of development and across therapeutic areas • Served as the CMC representative on Clinical Trial Submission Teams for assigned development compounds

• Developed regulatory strategy, prepared the CMC sections and responded to Agency questions in support of the EU marketing application of a new pediatric dosage form of a cardiovascular product, representing the first Article 29 procedure approved. Project was highly successful having significant company/franchise impact and overcoming a very low probability of success. • Prepared MOW filings in support of a drug substance source of supply change for an antiretroviral compound • Developed and implemented regulatory strategy in support of post-approval changes for several in-line product franchises • Prepared responses to Agency questions in support of initial worldwide registration of an antiretroviral product • Served as a key member of an operational excellence design team charged with developing a business process and principles for the conversion of CMC information to CTD format utilizing a new departmental authoring system. Participated in initial Kaizen event and led a group of scientists to implement the conversion • Acted as the Regulatory Liaison to the Canadian subsidiary to address regulatory and CMC issues specific to Canada • Developed strategy, authored and implemented a worldwide supplement in support of an alternate drug substance source of supply filing including an alternate synthesis, different in-process controls, and extension to retest period • Prepared an ASMF in support of an EU registration of a triple active combination antiretroviral product

• Provided regulatory support for in-line products including preparation of Annual Reports, worldwide registration renewals, post approval supplements, and responses to Agency questions • Prepared the analytical methods and validation sections for the WMA of an antiretroviral product • Prepared US PAS/Canadian Notifiable Change in support of a confidential network source of supply change under accelerated timelines which included changes to the manufacturing/stability site, product image, manufacturing process, specifications and composition

• Led the transfer of analytical methods to manufacturing sites, including the preparation of protocols, evaluation of data, and authoring of completion reports • Performed IQ/OQ and calibrations for several laboratory instruments • Acted as the lead site liaison to the Merck manufacturing facility in Korea • Developed methods to detect beta-lactam presence in other active pharmaceutical ingredients • Performed cleaning method validations to support manufacturing sites • Conducted method equivalency testing to reduce workload for manufacturing sites • Worked with stability and release sites in order to solve technical problems

• Characterized over 60 reference standards used for the release of pharmaceutical products worldwide • Trained new analysts on several laboratory instruments and techniques • Led atypical investigations and authored investigation reports • Authored and reviewed standard operating procedures and other laboratory documents

• Conducted release and stability testing for several products from the Gastroenterology and Neuroscience therapeutic areas • Performed assay, degradates, content uniformity, dissolution, identity, and moisture testing using a variety of analytical techniques and instrumentation including TLC, UV/Vis, HPLC, and KF

• Analyzed Benecol products by gas chromatography and gas chromatography mass spectroscopy • Developed extraction methods to separate stanols and sterols from Japanese oils and spreads