Justin G. Pennington, RAC

** * **** **, ***** ***, Memphis, TN 38103

901-***-****

abg8f5@r.postjobfree.com

REGULATORY AFFAIRS, QUALITY and COMPLIANCE PROFESSIONAL

Certified regulatory affairs professional with proven capacity for

strategic thinking and demonstrated proficiency directing top-level

regulatory initiatives within various sectors of the tightly regulated

pharmaceutical industry.

PROFESSIONAL PROFILE

. Compliance-driven, professional with an established background

developing, commercializing and distributing pharmaceuticals and

medical devices within domestic and international markets.

. Proactive self-starter with a track record of initiative, personal

responsibility, ownership of work, and a reputation for removing

obstacles and making things happen.

. Highly inquisitive and analytical thinker with a demonstrated ability

to scrutinize and achieve regulatory objectives.

. Strong leader, who effectively prioritizes tasks, motivates others and

directs top-level regulatory initiatives.

. Excellent interpersonal communicator, presenter, and implementer;

skilled in challenging conventional practices, facilitating

appropriate change and producing desired results.

AREAS OF EXPERTISE

PROFESSIONAL EXPERIENCE

Principal Consultant - Pennington Pharmaceutical Services LLC, Memphis,

TN - March 2010 - Present

Pennington Pharmaceutical Services LLC provides regulatory guidance,

oversight and an extensive list of outsourced compliance services to

small and medium sized pharmaceutical companies. Our services are

specifically designed for the meeting the regulatory, quality and

compliance needs of companies with limited expertise or inadequate in-

house resources.

My primary responsibilities at Pennington Pharmaceutical Services, LLC

include -

< Maintaining an up-to-date working knowledge of all FDA, DEA and State

regulations related to the development, production, marketing and

commercialization of Rx Drugs, Controlled Substances and OTCs for both

generic and branded products;

< Evaluating client operations and business goals to formulate proactive

regulatory strategies for getting the client's product to market by a

pre-determined date;

< Providing regulatory consultation, guidance, and industry insight to

clients on the regulatory aspects of new product development, product

registration and listing, state licensing, product labeling, product

marketing, PDMA compliance, supply chain management and security,

suspicious order monitoring, QA inspections, 21 CFR 211 and various

other aspects of product development and commercialization.

< Managing the state licensure portfolio of our clients, expediting the

application process through strategic use of our extensive network of

regulatory contacts within the various state boards of pharmacy.

< Developing and performing Compliance Reviews on client SOPs; conducting

mock FDA, DEA, VAWD & ISO compliance audits.

< Keeping clients up-to-date regarding the current regulatory

environment, providing recommendations concerning new and forthcoming

legislation and regulations.

< Performing compliance and quality audits on vendors/suppliers and

offering recommendations on vendor/supplier selection based on

compliance/quality standards, client needs, and vendor/supplier

capability and competency.

< Developing compliance and quality solutions specifically designed for

the unique needs of each individual client.

< Compiling, Organizing, Auditing and Submitting reports required by the

FDA, DEA, VAWD and state regulatory boards.

< Assisting foreign manufacturers commercialize product in the U.S.

Manager, Regulatory Compliance - DDN, Memphis, TN - January 2008 - March

2010

DDN is the largest, privately held outsourced service provider to the

life sciences industry, providing an extensive suite of manufacturer-to-

market services for over 100 pharmaceutical, biologics, and medical

device manufacturers worldwide

My primary responsibilities at DDN included -

< Ensuring internal compliance with all federal, state, and international

regulations by way of developing, implementing and continually

improving corporate regulatory systems and strategy;

< Serving as the corporate liaison for all internal/external regulatory

inquiries and negotiations; and

< Providing regulatory consultation, guidance, and insight to DDN's

client base (e.g., new product development, product registration and

listing, state licensing, product labeling, product marketing, PDMA

compliance, and various other aspects of product development and

commercialization).

My first responsibility with DDN was to evaluate existing regulatory

systems, enhance regulatory infrastructure, and develop corporate

regulatory policy, strategy, and procedures to support the operations of

DDN's distribution centers in Memphis, TN and Ontario, CA and corporate

headquarters located in Germantown, WI.

Several key accomplishments during my first year with DDN include -

< The implementation of comprehensive Controlled Substance and PDMA

Compliance Auditing Programs;

< The development and implementation of a proprietary Suspicious Order

Monitoring System; and

< Facilitating a corporate culture focused on establishing and

maintaining quality and compliance driven processes.

Manager, Regulatory Affairs, Quality, and Auditing - Cypress

Pharmaceutical, Inc., Madison, MS - August 2006 - December 2007

. As Manager of Regulatory Affairs, I managed the day-to-day

operations and longer term regulatory initiatives for one of the

Top 3 fastest growing private businesses in Mississippi,

specializing in the development, marketing and distribution of

generic prescription pharmaceutical products to the leading

national pharmaceutical wholesalers, chain drug stores,

distributors, and other retail merchandisers.

. My primary responsibilities at Cypress Pharmaceutical included -

< Ensuring internal and vendor compliance to all GMP/GCP requirements

and DEA, FDA, and State regulations;

< Managing the development of product labeling and marketing

materials, ensuring PDMA and 21CFR 203 compliance;

< Serving as the corporate liaison to all vendors, government

agencies, listing agencies, customers, and consumers for all

regulatory issues; proposing, negotiating, and facilitating prompt

and thorough resolutions as needed;

< Serving as the link between the product development team and

contracted vendors; auditing, approving and monitoring contract

vendors; issuing NDC numbers and product specifications to contract

vendors and providing regulatory oversight to ensure product meets

specifications; auditing contract vendor facilities to ensure

compliance with established protocols and regulations in place for

clinical studies, manufacturing operations, bioequivalence/stability

testing, labeling control, quality systems, record retention, etc.

< Assisting product development team prepare NDA, ANADA, DMF and

related submissions; managing product complaints, investigations,

CAPA analysis.

< Ensuring accurate and complete documentation for all products from

development throughout discontinuation;

< Handling product registration and listing with the FDA, DEA and all

applicable listing agencies;

< Preparing and presenting weekly "New Product Development" and

"Regulatory Update" reports to the Cypress Executive Management

Team;

< Managing internal Quality Assurance and Quality Control functions;

ensuring compliance with all applicable federal and state pedigree

laws; managing facility access restrictions and security;

. Several key accomplishments during my tenure with Cypress

Pharmaceutical included -

< The successful development and launch of more than 20 new generic

pharmaceutical products;

< The development of new packaging protocols for two contract vendors

to address frequent problems with faulty inner seals; assisted with

implementation of these procedures on-site at each vendor's

facilities;

< Developed and implemented new regulatory oversight procedures

pertaining to new product development operations performed by

outside vendors, resulting in increased adherence to established

timelines and better product quality.

Manager, Regulatory Affairs, Quality, and Auditing - Hawthorn

Pharmaceuticals, Inc., Madison, MS - August 2006 - December 2007

Hawthorn Pharmaceuticals is the brand-name, subsidiary company of

Cypress Pharmaceutical, Inc.

My responsibilities included managing all regulatory functions for

Hawthorn which I also performed for Cypress, while also performing

additional regulatory duties related to the marketing and

commercialization of brand-name pharmaceuticals-

< Managing PDMA compliance for the distribution of prescription drug

samples; developing, revising, and training sales force on internal

SOPs to ensure compliance with PDMA and 21CFR requirements.

. Key accomplishments during my tenure at Hawthorn Pharmaceuticals

included -

< In response to increased negligence pertaining PDMA compliance, I

devised and implemented a new corporate sampling program which

decreased PDMA non-compliance by over 95% within one month of

implementation.

< To better account for inventory of controlled substance samples, I

redefined operational procedures and departmental responsibility

through the implementation of new policies and procedures and

enhancing corporate infrastructure and training programs; following

implementation, the controlled substance sample inventory maintained

a level of 100% accountability.

Analyst - Eurofins Scientific, Memphis, TN - June 2005 - July 2006

Eurofins Scientific is a leading international group of laboratories

providing an unparalleled range of bio-analytical testing and support

services to the pharmaceutical, food, environmental and consumer

products industries and to governments. The company is a worldwide

leader in its field, offering a portfolio of 100,000 reliable

analytical methods for characterizing the safety, identity, purity,

composition, authenticity and origin of products and biological

substances.

SPEAKING ENGAGEMENTS

. State Licensing and Drug Distribution Regulations. Fifth Annual

Porzio Compliance Forum, Basking Ridge, NJ, October 2010.

CERTIFICATION(S)

. Regulatory Affairs Certification (RAC)

ORGANIZATION(S)

. Regulatory Affairs Professional Society (RAPS) - Voting

Member

. PDMA Alliance Member

. The Organization for Professionals in Regulatory Affairs

(TOPRA)

. North Carolina Regulatory Affairs Forum (NCRAF)

. Orange County Regulatory Affairs Discussion Group (OCRA)

. American Society for Quality (ASQ)

. National Association of Chain Drug Stores (NACDS)

. American Society of Consultant Pharmacists (ASCP)

. Global Risk Community

. Regulatory Intelligence for Pharma

. Drug Information Association

EDUCATION

. Bachelor of Arts in Biochemistry, University of Mississippi, 2005

. Bachelor of Arts in Psychology, University of Mississippi, 2005

REFERENCES

. Available upon Request

. FDA, DEA, EMEA and State Regulations

. New Product Development, Registration, and Listing

. Product Labeling and Marketing Compliance (e.g., 21CFR203, DDMAC, etc.)

. Supply Chain Management (e.g., PDMA & Pedigree Compliance, etc.)

. FDA, DEA, VAWD and State Reporting

. Full Product Life-Cycle Documentation

. FDA, DEA, VAWD and State Audit Management

. FDA, DEA, VAWD State & Vendor Negotiations

. Clinical Trial Compliance and Auditing

. Data Trending, Root Cause Identification, CAPA Analysis & Effectiveness

Checks

. Regulatory Strategy and Risk/Benefit Analysis

. Development, Implementation, and Enforcement of Regulatory/Quality

Policy and Procedures

. Internal/External Auditing and Vendor Selection

. GMP, GCP, GLP and GDP compliance

. Quality Systems (e.g., ICH, GMP/QSR, ISO, etc.)

. FDA/DEA Registration and State Licensing

. Continuous Process Improvement / Change Control

. Document Control & Compliance

. Employee Training & Teamwork Facilitation

. Biochemistry / Analytical Chemistry / Bioequivalence and Stability

Testing

. Import / Export Regulations

. Product Recalls, Complaints and ADR Reporting

. Development and Implementation of SOPs in compliance with FDA, DEA, VAWD

and State regulations

. Regulatory Research and Legislative Monitoring

. Regulatory Strategy and Presentations

. Crisis Management Programs and Resolution Strategies

. Theft/Loss Investigations and Reporting

. Suspicious Order Monitoring Systems and Reporting

. Electronic Records/Signatures Validation (e.g., 21CFR 11)

. Facility/Personnel Security and Access Restrictions

. Due Diligence Screening and Monitoring of Vendors

. Sales Rep Auditing and Inventory Accountability

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