CARMELLA S. MOODY, PH.D. 3500 Tonbridge WayDurham, North Carolina 27707

919-403-0902919-749-4209 (mobile)

carmellamoody@earthlink.netOffering 30 years of experience in development of small molecules and biotechnology products with emphasis in Regulatory Affairs, Project Management, and Quality Assurance. Direct “hands on” experience includes:

Regulatory Affairs:• Conceptualizing scientific and technical activities in accordance with FDA guidelines; • Development of regulatory strategies for US and international Regulatory submissions;• Preparation of regulatory dossiers for US and International applications. • Experienced with submission of regulatory dossiers to support clinical trial applications to US and international

agencies (e.g. Russia, China, Japan, EU, S. Korea, Taiwan, and Canada).• Directing the development and preparation of Marketing applications in CTD format and submitting

applications as eCTD.• Acting as the Regulatory Representative for companies at FDA and International Regulatory Agency meetings

(e.g. PMDA, MHRA, EMA, MFDS, Health Canada). • Directing the start-up activities for clinical studies for US and International programs• Developing post approval manufacturing change strategies to allow maximum ease of regulatory approval for

continual cost reduction and process improvement programs.• Development of comparability programs to support product changes.• Directing the development of CMC dossiers to meet US and International regulatory guidelines• Conducting and managing “due diligence” activities for “in-licensing” opportunities which include assessment

of drug substance and drug product manufacturing programs from a technical, cost, equipment resource, raw material sourcing, environmental containment, environmental disposal, CGMP quality, US and European CMC regulatory, product distribution and sales-force utilization perspective.

• Identification of contract facilities for development and manufacture of pharmaceutical products which includes assessment of analytical and manufacturing capabilities, equipment resources, containment capabilities, CGMP compliance for the phase of development of the drug substance or drug product.

Program/Project Management• Managing entire programs for development of small molecules, recombinant proteins and monoclonal

antibodies. Experience includes hiring staff and consultants as well as managing development of all aspects of the program including nonclinical and clinical studies and all aspects of development and manufacture.

• Conceptualizing and defining project plans with timings, costs and deliverables for development programs from pre-clinical through commercial supply.

• Project management of all manufacturing activities through contract development and contract manufacturers.

• Negotiating contracts and supply agreements with contract development, manufacturing, analytical, packaging & labeling and distribution facilities.

Quality:• Development of Quality Assurance systems for pharmaceutical & biotechnology facility start-up.• Development of Quality Control laboratories for pharmaceutical & biotechnology facility start-up.• Development of Quality Systems for a total electronic pharmaceutical manufacturing facility.• Oversight of manufacturing and analytical facility validation.• Development of validation protocols for equipment, systems and processes.• Review of batch records for scientific content and CGMP compliance.• Performance of CGMP Audits

Department Management:• Management and supervision of Regulatory Affairs Departments and staff including professional

development, performance appraisals and employee counseling/mentoring. • Development of proposals for client companies. Presentation at “bid defenses” and management of all

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activities relating to client projects.

EMPLOYMENT HISTORY:11/13-present Director, Regulatory Affairs, Pearl Therapeutics, Durham, NC

Responsible for activities leading to successful submission of regulatory applications to FDA and International Regulatory Agencies for COPD products.

10/10-10/2013 Director, Regulatory Affairs, Osmotica Pharmaceutical, Wilimington, NC

Responsible for leading activities for submission of regulatory applications to FDA and International Regulatory Agencies. Responsible as the regulatory agency contact for the company. Lead efforts for submission of INDs and 505(b)(2) NDAs for CNS products.

8/09-10/10 Senior Director Regulatory Affairs, SRA GCD, Durham, NC

Lead activities for support of client companies with regard to Regulatory Strategy and dossier submissions for US and International Agencies. Developed regulatory strategies and prepared bids and proposals for client companies. Directed business development activities for sponsor projects.

4/08-5/09 Vice President, Regulatory Affairs, Affinergy, Inc Durham, NC

Directed activities for development of regulatory strategy for an orthopedic device.

8/06-4/08 Principal Consultant and Director of Regulatory Affairs, SRA GCD (formerly Constella Group), Durham, NC

Lead activities for support of client companies with regard to Regulatory Strategy and dossier submissions for US and International Agencies. Developed regulatory strategies and prepared bids and proposals for client companies.

7/01-8/06 Principal Consultant, NextGen Pharma Consulting, Inc., Durham, NC.

Lead activities for support of client companies with regard to Regulatory Strategy and dossier submissions for US and International Agencies. Developed regulatory strategies and prepared bids and proposals for client companies.

8/97-7/01 Assistant Director World Wide Regulatory Affairs; Glaxo Wellcome Inc., Research Triangle Park, NC

Directed activities for successful submission of INDs and NDAs for CNS and Infectious Disease Products.

1/96-8/97 Director, Quality; Corning Bio Inc., (Covance Biotechnology Services, Diosynth), Durham, NC

Responsible for preparation and start-up of fermentation and cell culture contract manufacturing facility. Development of QC laboratories.

1/92-1/96 Senior Biopharmaceutical Scientist & Project Director/Pharmaceutical Development Department ManagerCato Research Ltd.

Lead activities for support of client companies with regard to Regulatory Strategy and dossier submissions for US and International Agencies. Developed regulatory strategies and prepared bids and proposals for client companies.

1/91-1/92 Manager, Fermentation and Diagnostic DepartmentsRhone-Merieux Inc.

Manager of fermentation product production for animal vaccine manufacturing facility.

1/88-1/91 Senior Research ScientistOrganon Teknika Corporation

Bench Scientist responsible for product development of an automated bacterial identification system.

1986-1988 Research Associate

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Duke University Medical CenterDepartment of Pharmacology

Post-doctoral fellow. Investigated the induction of Superoxide Dismutase in human umbilical cord endothelial cells.

1985-1986 East Coast Technical Applications ManagerB. Braun Instruments

Technical representative for support of client company fermentation applications and selection of appropriate fermenters for projects.

1984-1985 Research MicrobiologistW. R. Grace And CompanyWashington Research Center

Bench Scientist responsible for identification of microorganisms to carry out stereospecific conversion of specialty chemicals.

FORMAL EDUCATION:

1984 PH.D. Microbiology - North Carolina State University, Raleigh, North Carolina

1982 M.S. Microbiology - North Carolina State University, Raleigh, North Carolina

1980 B.S. Biology - College of Charleston, Charleston, South Carolina

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