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Microsoft Office Manager

Location:
Abington, Massachusetts, United States
Posted:
January 25, 2018

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Michael B. Morrison

*** ******* ***** 774-***-****

Abington, MA 02351 ac36su@r.postjobfree.com

Regulatory Affairs Specialist

A Recognized Expert, Versed in All Aspects of Regulatory Management Seasoned regulatory affairs professional with over 13 years of comprehensive experience managing strategic organizational efforts to facilitate registration. Employs strong interpersonal communication skills, highly adept at interpreting regulations and developing effective responses. Intently focused on pioneering efforts to enhance efficiency. CORE COMPETENCIES

Regulatory Affairs Critical Analysis Change Control Documentation Management Creative Solutions Cost Reduction Project Management Good Manufacturing Practices Microsoft Office Transition Collaboration Process Improvement EXPERIENCES AND ACHIEVEMENTS

The Boston Beer Company April 2016 – November 2017 Regulatory Affairs Specialist, Boston, MA

Managed US and international registration for multiple brands, including Samuel Adams and Traveler. Maintained state and federal licenses for breweries and subsidiaries. Collaborated with Product Development, Brand and Manufacturing departments to develop solutions and meet launch dates for Samuel Adams, Truly Spiked & Sparkling, Traveler and Concrete Beach brands.

Prepared and monitored regulatory submissions for domestic and international projects, including reviewing and referencing annual reports in response to regulatory authorities.

Developed enhanced tracking systems, ensuring improved accuracy of product registration and licensing.

Successfully established standard operating procedures to reflect current practices.

Saved department over $25k, by eliminating registration renewals for inactive and/or duplicate products.

Partnered with internal and external business units, playing key role in obtaining necessary licenses for new facilities. General Nutrition Centers (GNC) January 2005 – December 2015 Senior International Regulatory Affairs Specialist, Pittsburgh PA June 2011 – December 2015 Supervised regulatory processes for over 30 countries, including Australia, Saudi Arabia, and Malaysia. Evaluated new products to ensure compliance with all regulatory agencies in target markets. Coordinated the preparation of regulatory filings for drug submissions in Saudi Arabia and South Africa, including Chemistry, Manufacturing, and Control (CMC) section of CTD.

Collaborated with manufacturers and international clients to ensure adherence to Good Manufacturing Practices and standard operating procedures.

Liaised with manufacturers and raw material vendors, fostering good relationships to promote greater understanding of regulatory requirements and ensuring compliance objectives were properly met.

Created and managed multiple databases to ensure highly accurate tracking of registration.

Developed solutions in collaboration with Product Development, Science and Merchandising departments, to support necessary requirements, and decrease time and money spent by organization.

Led multiple teams in design of Regulatory Affairs Product Information Database (RAPID). International Regulatory Affairs Specialist, Ft Lauderdale, FL January 2005 – June 2011

Managed registrations for Latin America and Far East regions, including Costa Rica, the Dominican Republic and Turkey.

Organized inventory, processing, and distributing of data and materials, ensuring accurate product registration.

Guided communications with customers, international clients, departments, and manufacturers. EDUCATION

FLORIDA ATLANTIC UNIVERSITY, Boca Raton, FL

Bachelor of Arts, Liberal Arts

PALM BEACH STATE COLLEGE Boca Raton, FL

Associate Degree



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