Manager Quality

REGULATORY CMC AFFAIRS CONSULTANT

Name: Ahmed Email: aceox5@r.postjobfree.com

Cell: (916)470–2012 US Citizen.

Summary:

• 4 years of professional experience in Pharmaceutical Industry, 3 years of Regulatory Affairs

experience

• Exceptional Scientific and Technical skills for Project Management, Regulatory Affairs, Quality

Assurance and Compliance.

• Awareness and appreciation of cross-functional dependencies and various resources on projects

• Experienced SOPs, validation documents and qualification reports writer and reviewer

• Familiarity with drug development, electronic submissions, IND and NDA regulations, CTA and

MAA submissions to EMA and Health Canada, FDA acts such as FDAAA, FDAMA and FDASIA,

FDA guidance’s, and USP requirements

• Knowledge of various submissions types such as labeling supplements, PSURs, annual reports, CMC

amendments, IND amendments and IND safety reports.

• Outstanding organizational, communication, time management, coordination, and multi-tasking

skills; work well in teams and individually.

• Provide and/or implement global CMC regulatory strategy for development projects.

• Lead or contribute to global CMC submission activities (planning, authoring, reviewing,

coordination, submission) for assigned projects/products, while applying the global strategy into

submissions. Make quality regulatory decisions, balancing risks and benefits .

• Contribute to cross-functional CMC Health Authority Response Teams for assigned development

projects and prepare CMC responses, as appropriate .

WORK EXPERIENCE

Client: Merck Pharmaceutical January 2014 to Present

Role: Regulatory Affairs CMC III Associate

• Provide and implement global CMC regulatory strategy for development projects. Perform annual

updates of product Technical File to ensure audit readiness.

• Lead or contribute to global CMC submission activities (planning, authoring, reviewing,

1coordination, submission) for assigned projects/products, while applying the global strategy into

submissions.

• Design, produce, and coordinate updates to user manuals and labels to support product improvements,

packaging and sterilization validation constraints, and meet timelines.

• Identify required CMC documentation and any content, quality and/or timeliness issues with them for

global submissions and negotiate the delivery of approved technical .

REGULATORY CMC AFFAIRS CONSULTANT

Name: Ahmed Email: aceox5@r.postjobfree.com

Cell: (916)470–2012 US Citizen.

• Conduct vigilance assessments on product complaints to support final review from manager.

• Examine and analyze 510ks with a senior colleague to become familiar with submissions.

• Create graphics, design brochure layouts and edit marketing collateral to support rapid creation of

materials to support launch.

• Organize and run cross-functional meetings to plan labeling implementation to meet business needs.

• Initiate, investigate, and write complaints to assist busy quality group.

• Create, review, and approve label artwork, label specifications, and nonconformance paperwork in

controlled documentation system.

• Write work instructions, release SOPs, and create forms to establish quality documentation.

• Develop of matrices for ECOs and complaints and for management review.

• Work with cross-functional team to implement and maintain consistent branding across collateral.

• Attend a Quality System Regulations for the Medical Device Industry workshop.

• Working knowledge of chemistry/biotechnology, analytics and pharmaceutical technology.

Knowledge of the drug development process.

Client: DR. REDDYS Laboratories - Bridgewater, NJ March 2012 to

December 2013

Role: Regulatory Affairs

• Assess impact on Labeling based on upcoming NDA supplements or changes to

safety/pharmacovigilence data; modify Product Labeling, review and submit revised Labeling per

Regulations.

• Submit NDA supplements, post-marketing safety reports, PSUR and NDA annual reports to FDA

• Provide and implement global CMC regulatory strategy for development projects Author and train on

SOPs for regulatory activities such as labeling changes, NDA annual report preparation, and

submission of safety reports.

• Contribute to cross-functional CMC Health Authority Response Teams for assigned development

projects and prepare CMC responses Perform assessment audits and provide report to senior

management qualifying new packaging vendor and new manufacturing vendor

• Actively work with a quality consultant for quality inspections and product manufacturing changes

• Report to senior management submission activity, adverse events and product complaint reports and

other important issues on a monthly basis

• Work with a Law firm to keep state licenses in good standing; track and schedule renewal

applications and annual reports for state pharmacy boards as needed.

REGULATORY CMC AFFAIRS CONSULTANT

Name: Ahmed Email: aceox5@r.postjobfree.com

Cell: (916)470–2012 US Citizen.

• Ability to critically evaluate data from a broad range of scientific disciplines

Client: Sanofi-Aventis - Bridgewater, NJ

Role: Regulatory Coordinator (Consultant) September 2011 to February 2012

• Organized and executed kick-off meeting for an initial IND (eCTD format) with Project team.

• Followed up with minutes, additional resources, various supporting procedures, and training for

new process to start out on a good foundation aiming to lead the team to a successful initial IND

submission

• Provided support to Global Regulatory Liaison with Clinical development milestones

• Coordinated and supported preparation of Letter of intent and Final request for Scientific Advice

submission to EMEA

• Compiled documents for IND submissions to regulatory agencies such as IND amendments, SPA

requests, annual reports, meeting requests, and briefing packages as well as Investigator updates and

safety reports

• Planned and participated in team meetings, introduced regulatory templates, begin team

interactions and followed up on activities to secure timely submissions

• Assisted in coordination and submission of a request for special protocol assessment to

Carcinogenicity Assessment Committee

• Coordinated and provided needed support for preparation of an End-of-Phase-II briefing package

• Collaborated with Regulatory Operations and other functions (such as Clinical, Clinical

Pharmacology, CMC) to facilitate preparation, review and publishing of required submission

documents in a timely manner

Researched competitor information, past submissions, new regulations from Health Authorities and

literature requests using resources such as Internet, FDA and EMEA websites, Internal Library for

senior management

Client: Barr Pharmaceuticals - Montvale, NJ September 2010 to September 2011

Role: Regulatory Compliance Associate

• Collaborated with other disciplines (Clinical, Clinical Pharmacology, CMC, Medical Safety) and

REGULATORY CMC AFFAIRS CONSULTANT

Name: Ahmed Email: aceox5@r.postjobfree.com

Cell: (916)470–2012 US Citizen.

Regulatory Affairs to coordinate the preparation and review of required submission documents such

as IND and NDA Annual reports, PSUR, IND amendments, Request for Information, and NDA

supplements

• Compiled and performed appropriate quality checking of annual reports

• Supervised and trained a consultant for annual reports processes and was responsible for her role

and development

• Review electronically published submission documents using eCTD viewer

• Instructed involved personnel of associated FDA reporting requirements and timelines

• Maintained understanding of current FDA requirements through DIA courses and self-training

EDUCATION

MSC in Chemistry Osmania University - Hyderabad, A.P

BSc in Chemistry Osmania University – Hyderabad, A.P

SKILLS

COMPUTER SKILLS and PHARMACEUTICAL SKILLS below

ADDITIONAL INFORMATION

COMPUTER SKILLS: Documentation and communication systems:

Adobe Acrobat 5.0, Compliance Wire, ISI toolbox, SAP BO, SharePoint, Microsoft Project, Microsoft

Internet Explorer, Microsoft Office, Lotus Notes, and Microsoft Outlook Chromatographic Data Systems

Millennium, Track wise and Empower Laboratory Information Management System (LIMS) and other

software: ChemLMS from HP, Creon’s ELISA LIMS, Beckman’s Lab Manager, Blue Mountain’s

Calibration Manager, GE Infrastructure Sensing's (Kaye) Lab Watch, Remedy’s Action Request System

PHARMACEUTICAL SKILLS: Familiarity with FDA guidelines, experience with submissions to

EMEA and Health Canada, electronic submissions in eCTD format and via electronic submissions

gateway (ESG), collaborate with external service providers such as Octagons, USP guidelines, complete

understanding of cGMPs, GLPs and GCPs, NDA and IND phase training from DIA, Drug Development

training from PERI, and Knowledge of HPLC, UV Spectroscopy, Gas Chromatography, Capillary

Electrophoresis, Atomic Absorption, Dissolution

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