Project Manager Development

OVERVIEW

Experience in leading multidisciplinary teams that support the development of new products and support the improvement of current products in all stages of product life cycle management including coordinating with regulatory affairs.

Extensive knowledge and strong understanding with IND, NDA, and ANDAs.

Highly innovative professional with proven track record in solving complex development problems, implementing and improving manufacturing processes within the boundaries of regulatory guidelines.

Demonstrated strong oral and written communication skills, including experience in presenting information to Senior Management and other departments

Proven experience of managing people and supervising interns.

Very proactive, with proven ability to work independently, and in multifunctional teams.

Strong planning and strategy skills; attention to minute details.

Excellent time and project management skills.

Experienced and refined organizational, interpersonal & communication skills.

Outstanding work ethic and dedication.

Well versed in the applicable regulatory guidance’s and proven ability to interpret and guide the development personnel.

EXPERIENCE

Feb. 2016 iMedGlobal Corporation Princeton, NJ

Regulatory Affairs, Project Manager

Led multidisciplinary teams that support the development of strategies for the registration of all Domestic and Foreign Sites that fabricate, package / label, and test for Johnson and Johnson Canada.

Coordinated the registration of new products for Johnson and Johnson Canada and affiliated sites throughout North America and Europe.

Developed and maintained regulatory systems and databases for Johnson and Johnson Canada.

Translating vast amounts of data into work processes for desired outcomes.

Was involved in writing and reviewing the annual renewal to be submitted to the Canadian Health Authority for Johnson and Johnson Canada site.

Jan. 2012 Lannett Company Inc. Philadelphia, PA

Process Engineer, Technical Services

Ensure that commercial opportunities are maximized by implementing sound planning that is focused on commercial objectives that also maintains company integrity and compliance.

Responsible for trouble shooting, worked closely with Regulatory Affairs department to ensure that the steps taken forward would not impact the commitments made in the regulatory applications.

Managed the manufacturing of regulatory submission, Technology Transfer, Process Validation and Submission batches.

Developed robust manufacturing processes and established critical process parameters for a series of new product approvals and conducted process validation.

Evaluated existing manufacturing processes and improved them by building efficiencies and enhancing quality within the confines of the SUPAC post-approval guidelines.

Was involved in the development of products, using wide array of manufacturing processes, from product Development to Process Validation and ensured that they are within the approved specifications.

Collected and evaluated the data from Process Validation batches using statistical programs and installed process specific improvements and embarked on remediation by coaching the operators and supervisors.

EDUCATION

Jan 2014 – Dec 2015 LONG ISLAND UNIVERSITY Brooklyn, NY

M.S. in Drug Regulatory Affairs

Prepared a mock IND in CTD format for fictitious drug Chlorvincanol (Seniger), a drug used to reduce the progression of senile dementia. Developed and presented the regulatory strategy as it was awarded breakthrough designation. Was responsible for the preparation of module 3 (CMC section) and module 5 (clinical section), also assisted in the remaining modules.

Well versed with the guidances for labelling, advertising, and promotion. Knowledgeable with the regulations for brief summary, off label use, and direct to consumer advertising.

Jan 2012- April 2013 Temple University Fort Washington, PA

Certificate in Drug Development

The program provides the tools and information needed to develop new pharmaceutical drugs and conduct clinical trials.

It emphasizes the extensive lab studies conducted during pre- development, ensuring safety and efficacy in clinical trials (learned from Phase 1 – 3), and the continued analysis seen in post market surveillance.

Graduated DEC 2011 UNIVERSITY OF THE SCIENCES Philadelphia, PA

B.S. in Pharmaceutical Sciences School of Pharmacy

Headed the Diabetes Screening team, 2009-2010

Dean’s List (GPA 3.5 or higher), 2007-2008

CAREER ACCOMPLISHMENTS

Submitted a total of 4 products to the FDA. Additionally I have been the lead in scaling up, process development and validation of 10 products and transferred to the commercial manufacturing team.

Received the 2013 QTIP performance award for demonstrating Quality, Teamwork, Integrity, and Professionalism.

Have been awarded the responsibility of working on a total of 15 different products in various stages of development, from Research and Development to Process Validation.

Involved in compiling responses to several FDA deficiencies for a series of FDA submitted Products allowing timely approvals.

Submitted a total of 8 Drug Establishment Licences to the Canadian Health Authority to avoid missing site registration deadlines.

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