Colleen Mcgraw Email & Phone Number

Boston, Ma, Us

Cambridge, Massachusetts, Us

Provides oversight of the end-to-end labeling process, including generation of Company Core Data Sheets, new prescribing information and changes to existing labeling, and submission of labeling information to Health Agencies.Key COVID-19 Highlights:Sept 2023: Spikevax XBB.1.5 EU (60 total variations as of June 2024)Oct 2022: Spikevax BA.4-5 EUSept 2022: Spikevax BA.1 EUSept 2022: Spikevax (original) standard marketing authorisation in EUplus 60+ local labels to support global vaccinationJune 2024: CCDS (19 versions)Other mRNA Highlights:May 2024: mRESVIA US BLA approvalSept 2023: Filed mRNA-1345 (RSV) in EU and other major markets

Brentford, Middlesex, Gb

Responsible for leading labeling activities during pre- and post-approval phases for legacy TESARO assets niraparib and dostarlimab. Advise teams and management on the regulations, guidance, and industry best practices related to product labeling. Advise and support cross-functional teams during labeling discussions with regulatory authorities and during labeling development.Key Career Highlights:March 2020: Dostarlimab MAA Submission

Waltham, Massachusetts, Us

Responsible for leading labeling activities for products during pre- and post-approval phases. Advise teams and management on the regulations, guidance, and industry best practices related to product labeling. Advise and support product teams during labeling discussions with regulatory authorities. Develop regulatory processes, procedures and infrastructure to support company growth. Develop and implement efficient labeling processes for core and regional labeling. Participate in cross-functional team meetings during labeling development. Manage internal labeling teams and external consultants/vendors.Key Career Highlights:April 2020: Zejula (niraparib) PRIMA sNDA ApprovalMarch 2020: TSR-042 (dostarlimab) MAA SubmissionFebruary 2020: Zejula (niraparib) PRIMA Type II EU SubmissionDecember 2019: Dostarlimab BLA SubmissionOct 2019: Zejula (niraparib) QUADRA sNDA ApprovalJune 2019: Zejula (niraparib) Health Canada ApprovalOctober 2018: Zejula (niraparib) Official Decision – SwitzerlandJanuary 2018: Varuby (rolapitant) Official Decision – SwitzerlandDecember 2017: TESARO Sapphire Award Q3November 2017: Zejula (niraparib) EC Decision – EU October 2017: Varubi (rolapitant) injectable emulsion FDA ApprovalApril 2017: Varuby (rolapitant) EC Decision – EU March 2017: Zejula (niraparib) FDA Approval

Tokyo, Jp, Jp

Responsible for managing Shire’s Global Labeling function. Provided regulatory expertise and guidance to internal stakeholders for development of CCDSs and global labeling; formulated and implemented regulatory strategies. Oversaw the CNS, GI and Metabolic Therapeutic Areas as Labeling Team Lead.

Rahway, New Jersey, Us

Same duties as Cubist during transition period following the acquisition.

Lexington, Ma, Us

Responsible for coordinating the strategic development and risk assessment of activities in support of global prescribing information development (Core Data Sheet and local labels), as well as lifecycle management for marketed products. Chaired the Global Labeling Committee (GLC) for review and approval of all labeling for development and marketed products:Cubicin (daptomycin for injection)Dificid (fidaxomicin) tabletsEntereg (alvimopan) capsulesSivextro (tedizolid phosphate)Zerbaxa (ceftolozane/tazobactam for injection)In collaboration with the Regulatory Affairs leadership, integrated overall business objectives into departmental goals while collaborating with cross-functional teams that established regulatory strategy for drafting global labeling documents. Contributed strategically to facilitate the development of comprehensive drug product labels that were consistent with corporate strategy, and competitive with other agents in the class.Recent label approval experience:July 2015 Zerbaxa (ceftolozane/tazobactam) for Injection CHMP Positive OpinionMarch 2015 Sivextro (tedizolid phosphate) MAA ApprovalMarch 2015 Sivextro (tedizolid phosphate) NDS ApprovalDecember 2014 Zerbaxa (ceftolozane/tazobactam) for Injection NDA ApprovalNovember 2014 Cubicin (daptomycin for injection) Supplement ApprovalJune 2014 Sivextro (tedizolid phosphate) NDA ApprovalPlus regional filings for EU, Canada, Australia, Switzerland and New Zealand

Boston, Ma, Us

Responsible for regulatory strategy and operational leadership as the head of global product labeling for all marketed products and development programs. Chaired the multidisciplinary Label Working and Review Groups as well as Executive Label Committee for the Core Data Sheet, US and EU labels, including label negotiations with global health authorities. Oversaw review, approval, tracking and archiving of these documents. Worked closely with Project Management and Technical Operations to ensure rapid global product launches and implementation of labeling changes, including site visits with vendors and CMOs.Responsible for filing Proprietary Name requests and assisting Regulatory Strategy with other electronic filings as needed (e.g., ATU Programmes, ATC codes, Drug Listing, SPL, and Annual Reports). Maintained web site updates and historical labeling changes, and communicated labeling changes to stakeholders as needed, including partners in the EU and Japan.Mentored and trained regulatory staff through multiple departmental and reorganizational changes. Recent label approval experience:July 2012 Kalydeco (ivacaftor) MAA approvalMarch, June, Dec 2012 Incivek (telaprevir) Supplement Approvals Jan 2012 Kalydeco (ivacaftor) NDA approvalAugust 2011 Incivek (telaprevir) NDS approvalMay 2011 Incivek (telaprevir) NDA approvalPlus regional filings and approvals for Canada, Australia, Switzerland, and New Zealand; 6 Label Supplements for Incivek and 4 Label Supplements for Kalydeco

Boston, Ma, Us

Promoted to DirectorRecruited to form brand-new labeling function to prepare company for upcoming global regulatory submissions, approvals, commercial launch and post-marketing success.

Rtp, Nc, Us

Recruited to create the future process for labeling development, revision, review, and approval that had historically been handled by QA.Provided regulatory guidance for U.S. labeling content for all Stiefel dermatology and skincare products (Rx, OTC drugs, cosmetics, devices, and dietary supplements). Assisted in garnering FDA approval of the RiskMAP for Soriatane in October 2007.Provided sole regulatory labeling support for launch of Extina in June 2007. Managed and prepared labeling submissions to FDA, including management of SPL conversion and annual reports.

Us

TAP was a joint venture between Abbott Laboratories and Takeda Pharmaceuticals. During my tenure there, I worked with a small team of pharmaceutical industry colleagues on an FDA-mandated Medication Guide for NSAIDs, for which TAP's drug NapraPAC fit in. I also helped to choose TAP's vendor for SPL prior to that FDA mandate. I helped to work on the draft labeling for two drugs pending NDA filings and oversaw many process improvements with our partners.

Geneva, Switzerland, Ch

During these years, I headed the Labeling Operations group at Alcon, which served as Alcon's centralized labeling supplier for all global products manufactured at their Fort Worth site. I managed a staff of seven and oversaw the implementation of online labeling review that greatly helped to reduce cycle time and improve version control and electronic storage and retrieval.Responsible for managing the day-to-day labeling operations for all domestic and global ophthalmic consumer, pharmaceutical and surgical drugs/devices manufactured within Fort Worth and various contract manufacturing sites. Helped Alcon to meet its aggressive launches with same- or next-day turnaround of labeling with products such as Opti-Free Express, Opti-Free Plus, Vigamox, CiproDex, Systane and several generic pharmaceutical products. The manufacturing site in Madrid, Spain was sold in 2003, and our group exceeded extremely tight timelines to provide new labeling for EU countries for Fall 2003 production. Responsible for authoring, maintenance and training for several labeling-specific SOPS.

Malvern, Pa, Us

I helped to create and implement labeling for sNDAs, CBEs and Annual Reports for Endo's well-known drugs such as Percocet and Percodan and all of their generics, as well as new packaging for Lidoderm.

Cambridge, Cambridgeshire, Gb

I worked on a one-year contract within Astra's Marketing Communications department, focusing mainly on advertising pieces and the related labeling for Prilosec. I also helped to work on the merger integration handbook which served as a style guide for logo usage, etc. during the transition from Astra merging with Zeneca.Duties included ensuring the accuracy of printed labeling and promotional marketing components (such as core visual aids, detail pieces, journal ads, and package inserts) against approved Quality Assurance copy for marketed products such as Prilosec, Pulmicort and Rhinocort.

This entry into the pharmaceutical field allowed me to learn the basics of pharmaceutical labeling from the ground up. Duties included proofing and editing of all labeling components for marketed products such as Lovenox, Azmacort, Nasacort AQ, Taxotere, BenzaClin, and CombiPatch.

Mba, General

Ba, Communications

High School Diploma, College Preparatory

Executive Education, Moderna Ai Academy