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Regulatory Affairs Associate

Location:
United States
Salary:
$70,000
Posted:
July 28, 2010   all resumes
Email:
alyn0a@r.postjobfree.com
Contact Info:
*************@*****.***


PROFILE
Regulatory Affairs professional with experience working in the global headquarters of a pharmaceutical manufacturer, with multiple manufacturing sites and regulatory authorities. Demonstrated analytical and communication skills that encompass identifying critical concepts, solving complex problems, presenting complex ideas in a clear, concise and persuasive manner and keen attention to detail. Proven ability to effectively manage time and multiple projects, contribute effectively to project teams, achieve deadlines and collaborate with colleagues on a global level.
OBJECTIVE
Seeking a challenging position in the Philadelphia metro area that will utilize my pharmaceutical industry knowledge and experience to aid in the life cycle management of existing products and provide regulatory advice for bringing new products to market.

Core Competencies:
Biologic Drug Products (Vaccines) Data Acquisition and Analysis Scientific/Medical Writing
Project Scheduling and Planning FDA Regulations Molecular Biology/Biochemistry

PROFESSIONAL EXPERIENCE

CSL LIMITED – Parkville, Vic, Australia, 2008 - Present
Regulatory Affairs Associate
Roles and Responsibilities
• Provided regulatory and guidance to Manufacturing, Validation, Quality Control, Quality Assurance, Supply and Logistics, Project Management, Stability and Clinical colleagues.
• Prepared and coordinated BLA, IND, CMC and other regulatory submissions (including annual reports and responses to agency questions) to the FDA. Prepared submissions to other global regulators.
• Reviewed documents including clinical study reports, labeling drafts and validation and stability protocols and reports.
Achievements
• Project managed the Annual Strain Update for Influenza Virus Vaccine in the US. Reduced the time for submission by two months and transformed CSL from being last to first on the market, resulting in significant increases to company sales and profit.
• Served on the Clinical Expert Teams for four US clinical studies. Drafted and reviewed documents for IND submissions to support the four clinical studies, including study protocols, investigator brochures, analytical procedures, Certificates of Analysis, clinical trial labeling and final clinical study reports.
• Oversaw the maintenance and tracking of the stability program for Influenza Virus Vaccine in the US. Reviewed and provided regulatory advice on stability protocols and reports, as well as Biologic Product Deviation Reports and Out of Specification Investigations. Transformed the traditionally difficult relationship between stability and regulatory affairs into one of collaboration, respect and understanding.
• Chosen as a company representative for the Australian National Youth Science Forum, to mentor young scientists regarding careers in science and the pharmaceutical industry.

Regulatory Affairs Officer
Roles and Responsibilities
• Assessed change controls and prepared submissions arising from the change control process.
• Reviewed documents including SOPs, analytical procedures and validation and stability protocols and reports.
• Maintained product core dossier and product master files.
• Ensured that local and international websites were monitored and updates regularly distributed to key stakeholders.
Achievements
• Implemented an improved process to update, review and submit product labeling across multiple manufacturing sites and Merck, the US distributor.

• Contributed to the strategy, drafting and review of documents and labeling for the registration of a Monovalent Influenza Virus Vaccine, following the emergence of a pandemic influenza H1N1 strain in 2009. The new vaccine was registered within three months.
• Contributed to the drafting and review of documents for the registration of a new fill and finish site for
• Prepared work instructions for the regulatory department on the preparation and submission of a Clinical Postmarketing Commitment Annual Report for the US, and on how to manage the Annual Strain Update for an Influenza Virus Vaccine for the US.

NATIONAL INSTITUTES OF HEALTH (NIH) - Bethesda, MD, USA, 2003 – 2008
Postdoctoral Fellow
• Research topic: Mechanisms involved in causing Diabetes and Alzheimer’s disease.
• Developed novel methods for producing and expressing proteins involved in Diabetes and Alzheimer’s disease.
• Cured Parkinson’s disease in a nematode model of neurodegeneration and determined the potential mechanism.
• Awarded the NIH Fellows Award for Research Excellence for research on Parkinson’s disease in the nematode.
• Presented research findings at both national and international meetings.
• Developed projects for and supervised students in the laboratory.

AUSTIN RESEARCH INSTITUTE - Heidelberg, Vic, Australia, 1999-2003
PhD Student
• Research topic: The role of blood group antigens in pig-to-human organ transplants.
• Determined the structure and function of enzymes involved in creating blood group antigens.
• Discovered novel blood group antigens that could prevent the acceptance of organs in a pig-to-human transplant.
• Awarded a University of Melbourne research scholarship to fund PhD, as well as a University of Melbourne travel scholarship to present research at the XVI-International Symposium of Glycoconjugates, in The Hague, Netherlands.

BERNARD O’BRIEN INSTITUTE FOR MICROSURGERY - Melbourne, Vic, Australia, 1998
Honors Student
• Research topic: Why cell death is induced following re-plantation of injured or severed limbs.
• Discovered the initiating biochemical process in skeletal muscle that causes cell death following re-plantation of an injured limb.
• Only student in the 1998 Honor’s year to publish a first author paper from their research.

COMPUTER SKILLS
• Documentum (Intermediate) • Adobe Photoshop (Intermediate)
• Word (Advanced) • Adobe Illustrator (Intermediate
• Excel (Intermediate) • Adobe Acrobat (Advanced)
• Powerpoint (Advanced) • Outlook/Eudora (Advanced)

EDUCATION
University of Melbourne - Melbourne, Australia
Doctor of Philosophy (PhD)
• Thesis Title: Structure function studies of the a(1,3)Gal/GalNAc family of glycosyltransferases.
(In collaboration with the Austin Research Institute)

University of Melbourne - Melbourne, Australia
Bachelor of Science (Honors)
• Honors Thesis Title: Mast Cell Activation; A pivotal step in the aetiology of ischaemia reperfusion injury of skeletal muscle. (In collaboration with the Bernard O’Brien Institute for Microsurgery)

University of Melbourne - Melbourne, Australia
Bachelor of Science (Major: Pathology; Minors: Biochemistry, Microbiology)

PUBLICATIONS

Lazarus BD, Love DC, Hanover JA. O-GlcNAc cycling: Implications for neurodegenerative disorders. Int J Biochem Cell Biol 2009 Nov; 41(11):2134-46.

Christiansen D, Milland J, Dodson HC, Lazarus BD, Sandrin MS. The cytoplasmic and transmembrane domains of secretor type alpha1,2fucosyltransferase confer atypical cellular localisation. J Mol Recognit. 2009 May-Jun; 22(3):250-4.

Forsythe ME, Love DC, Lazarus BD, Kim EJ, Prinz WA, Ashwell G, Krause MW, Hanover JA. Caenorhabditis elegans ortholog of a diabetes susceptibility locus: oga-1 (O-GlcNAcase) knockout impacts O-GlcNAc cycling, metabolism, and dauer. PNAS 2006 Aug 8;103(32):11952-7

Milland J, Christiansen D, Lazarus BD, Taylor SG, Xing PX, Sandrin MS. The Molecular Basis for Gal{alpha}(1,3)Gal Expression in Animals with a Deletion of the {alpha}1,3Galactosyltransferase Gene. J Immunol. 2006 Feb 15;176(4):2448-54.

Lazarus BD, Love DC, Hanover JA. Recombinant O-GlcNAc Transferase Isoforms: Identification of O-GlcNAcase, YES tyrosine kinase and Tau as Isoform-specific substrates. Glycobiology 2006 May;16(5):415-21

Lazarus BD, Roos M, hanover JA. Mutational analysis of the catalytic domain of O-linked N-acetylglucosaminyl transferase. JBC 2005 Oct 21;280(42):35537-44.

Jinek M, Rehwinkel J, Lazarus BD, Izaurralde E, Hanover JA, Conti E. The superhelical TPR-repeat domain of O-linked GlcNAc transferase exhibits structural similarities to importin alpha. Nat Struct Mol Biol 2004 Oct; 11(10):1001-7.

Lazarus BD, Milland J, Ramsland P, Mouhtouris E, Sandrin M. Histidine 271 has a functional role in pig alpha-1,3galactosyltransferase enzyme activity. Glycobiology 2002 Dec;12(12):793-802.

Lazarus B, Messina A, Barker JE, Hurley JV, Romeo R, Morrison WA, Knight KR. The role of mast cells in ischaemia-reperfusion injury in murine skeletal muscle. J Pathology 2000 Aug; 191(4): 443-448.