regulatory affairs supervisor resume example with 9+ years of experience
JessicaClaire
Montgomery Street, San Francisco, CA94105609 Johnson Ave., 49204, Tulsa, OK
H: (555) 432-1000
C:
resumesample@example.com
Date of Birth:
India:
:
single:
:
Professional Summary
Well-organized and diligent Regulatory Affairs Specialist adept at coordinating and tracking regulatory-related actions. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering more than 9 years of experience in pharmaceutical industry at different core area like Intermediates & API route of synthesis, formulation analytical method development and analytical method validation, and formulation Quality control, looking for a challenging new role.
Skills
Expertise in interaction with internal CFTs
Written and oral communication skills with internal departments as well as with agents/clients
Able to grasp new concepts quickly and to assimilate and evaluate scientific data
Superior communication, presentation, interpersonal and teamwork skills
Proven ability to prioritize, conduct, and manage time to meet project deadlines
Dealing critical things with positive attitude.
Well experienced in analytical data interpretation against ICH guidelines.
Having good experience in troubleshooting to dissolution issues of transdermal patches
Supporting and providing trainings to the teammates on technical issues
Maintaining Good Documentation with Up to Date.
Well experienced in conducting weekly meetings with department head and team.
Transdermal patches dosage forms handling experience
Stability data -review and result interpretation against ICH Q1A (R2)
Finished product specifications- review and result interpretation against ICH Q6B
Related substance - review, impurities calculation and result interpretation against ICH Q3B(R2)
Since i have experience in API, significantly, i can review and finalize DMF/ASDMF
Work History
Regulatory Affairs Supervisor, 08/2020 - Current Axalta Coating Systems – El Paso, TX,
Roles and Responsibilities:
Significantly, I can review DMF (Drug Master File) each and every section with analytical data evaluation. Participating in discussion with CFTs/3rd party (Originator of DMF) and rectify all the issues to finalize DMF
Review of MPC (Master Production Card) and providing guidance to production department as per regulatory requirement
Review of PDR (Product Development Report) and providing guidance to R&D department as per regulatory requirement and preparing final PDR document as per CTD
Review of Manufacturing process and preparing final document as per CTD requirement
Review of Specifications, Standard Testing Procedures of Finished product, excipient and packaging materials against ICH guidelines and other pharmacopoeias
As I have real time experience in doing Analytical Method Validation, significantly I can review AMVRs against ICH guidelines, evaluate, and provide new formats to CFTs (Cross functional teams) for AMVRs. Preparing final AMVRs to include in dossier as per CTD format.
Having real time experience in stability samples testing, so significantly I can review stability data against ICH guidelines and prepare final stability data in GMP format to include in dossier
Comparison of in-house Analytical Method against pharmacopeias methods (e.g., Chromatography (USP-NF, Content uniformity by HPLC (USP-NF, pH USP-NF etc.,
Review of SOPs related to Quality department, Pharmacovigilance department, and SMF (Site master file), etc.,
Preparing CMC (Chemistry, Manufacturing and Control) sections for regulatory documents through product life cycle
In current job profile, we (RA) department is collaboratively working with International business team, so I have a good communication and relationship with them in business prospective.
Able to compile dossier to ROW countries and other country specific dossier compilation
Able to compile dossier in CTD, eCTD and ACTD format.
Analysis Scientist, 12/2019 - 07/2020 Air Liquide – Newark, DE,
Roles responsibilities:
Plan and execute analytical experiments to develop new method for Assay, RS and Dissolution tests with systematic approach
Significant experience with a broad variety of analytical techniques, such as liquid chromatography, Thin layer chromatography, titration and UV-Vis spectroscopy etc.,
Well experienced in conducting troubleshooting for complex technical issues and to lead major characterization studies
Having good understanding of technical and regulatory expectations regarding analytical development, analytical method validation and product characterization
Preparation of Specifications and standard test procedures as per ICH (Q6B) guidelines
Preparation of Analytical Method Validation Protocols as per ICH Q2(R1) guidelines
Real time experience is advantage to review all the documents required to include in Dossier sections
Analysis Chemist, 10/2016 - 10/2019 National Pharmaceutical Industries Co. SAOG (oman) – City, STATE,
Analytical Method development:
Literature survey for new targets or projects
Method development of drug products for Assay, Related Impurities and Dissolution by using HPLC based on QbD Approach
Method development of IR, DR, ER formulations using various dissolution Apparatus (USP-1 and USP-2)
Method Comparison study for Compendia Methods and In-house Methods
Mass Compatible Method Development for Related Impurities methods to isolate the impurities
Preparation of Method Development Plans and Reports.
Analytical Method validation:
Experienced in analytical method validation of different tests such as Assay, CU, UOD, Dissolution and Related Impurities by Using HPLC/UV/TLC
Well experienced in preparation of analytical method validation protocols and reports as per ICH guidelines
Transferring new analytical techniques to the Quality Control (QC) laboratory.
Quality Control Department:
Testing of Finished, Stability, in process and raw materials samples by instrumental methods as per Specifications
Responsible for Performing Analysis of Hold time study samples by instrumental methods as per Specifications
Assist in the investigation and root cause analysis of analytical quality issues, including OOT/OOS results, generated during a study and execution of associated CAPA according to internal quality procedures
Performing Analysis of Cleaning method Validation by instrumental methods as per protocols
Observing and complying with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP)
Held responsibility to monitor and maintenance of HPLC, UV-Visible Spectroscopy, Dissolution apparatus and other instruments
Reference standards maintainable in-charge
Standardization of reagents to determine the exact concentration (molarity)
Analysis of blend and finished product samples by Titration techniques
Participating in CFTs meeting along with CEO to discuss on technical issues and time lines
Pro-actively completing the targets on time to meet the time lines
Water for pharmaceutical purposes samples chemical analysis
Dissolution samples testing by AAS instrumental methods.
Senior Research Associate, 12/2012 - 10/2016 Syngene International Ltd. (A Biocon Company) – City, STATE,
Roles and Responsibilities:
Expertise in carrying out Multi-step synthesis of organic molecules from gram scale to plant scale and their characterization.
Optimization of synthetic route for intermediates and APIs
Expertise in transfer of Lab technology to pilot plant for commercialization
Good experience in optimization, process development and pilot scale development for client-based products such as Novartis, GSK and Achillion.
All the Novartis projects were developed, produced small scale batches, and successfully shipped to the client on time as per client requirement.
Expertise in handling named reactions, coupling reactions and hazardous reactions.
Plan and execute experiments, IPC check, analytical data interpretation, crude purification and troubleshooting.
Record and analyze scientific data/observations in detail. Write technical updates/reports. Daily update of Lab Note Book and experience writing client provided LNBs as per client requirements.
Handled “SAP software” for daily activities such as raising request to collect reagents, chemicals, raw materials, intermediates and raising A.R numbers for test samples and weekly report submissions…etc.
Handled multiple projects with minimal supervision. Manage project timelines and deliverables
Use a variety of analytical methods to monitor reaction processes
Ensure compliance of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) in the manufacturing facility.
Evaluating documentation and operations according to company procedures.
Preparation of master documents (like Standard Operating Procedures, Equipment Operating Procedures and Equipment Cleaning Checklists).
Preparation and review of Product development report
Analytical data interpretation of Assay (HPLC), Related substances (HPLC and TLC), 1H NMR, 13C NMR, LC-MS, P-XRD, particle-size distribution, Metal content, ROI, ROE, Heavy metals, UPLC and specific optical rotation.
Senior R&D Chemist, 08/2011 - 12/2012 Arene Life Sciences Limited. (Hyderabad, India) – City, STATE,
Roles and Responsibilities:
First three Months - Training Period.
Assisting to superiors in planning and executing of organic reactions
Purification of Reaction mass & isolation of impurities by Column chromatography
Excellent understanding of passion for safe work procedures & practices
Maintaining laboratory journals & records as per procedure
Interacting with QC team to evaluate the analytical data of In-process, crude and final drug.
Well trained in handling of pilot plant reactors
Observation of production activities and guidance to production team
Education
Master of Science: Science , Expected in 10/2011 - Osmania University - Telanagana, GPA: Status -
Bachelor of Science: Science , Expected in 06/2009 - Kakatiya University - Telangana, GPA: Status -
Accomplishments
Successfully completed the evaluation and comparison of in-house analytical procedures against USP-NF pharmacopeias methods (e.g., Microbial test, Optical rotation, solubility, pH, Water determination, Bacterial endotoxin, Sterility, Sub-visible particles, Visible Particles, Color and clarity).
Generated the new formats as per GMP for Analytical method validation reports (Assay, RS, Bacterial endotoxin, and sterility tests)
Successfully completed Thymalfasin “Dossier compilation” for India, panama, Philippine's and Vietnam in CTD format
Participated and successfully completed company's internal program “WCM” (World Class Management- International Registration Efficiency Improvement) in which all the CFTs will be participated weekly once and discuss on project issues and time lines
Successfully completed the evaluation and review of Thymalfasin, Thymopentin and Atosiban “DMFs” (Drug master files).
Successfully resolved the queries received from agent on submitted projects within the timeline.
Introduced new changes in existing systems like good documentations etc.,
Successfully achieved method development for Flurbiprofen Cataplasms
Participated in EU audit from beginning to ending and involved in each and every process of audit from Analytical development laboratory and Quality Control departments. Successfully completed the EU audit with approval
Increased the output ratio of release batches almost two time than actual output by doing smart work and got appreciation from department head
Successfully completed evaluation and testing of OOS samples for many products.
Successfully achieved the sample preparation for critical products like Omathrocin oral suspension (Reconstitution process)
Successfully completed trainings on ALCOA, ALCOA+ and other GMP trainings
Successfully resolved dissolution by AAS (Atomic Absorption Spectrometry) issues for many products like Calcy 600mg tablets, Ironic capsules, etc
Successfully set a “Titration method” for Omacid tablets
Successfully developed “TLC method” for Naproxen tablets
Successfully closed all the “Lab incidents”, “Deviations”, “OOS”, and other documents on time with proper justification without fail
Significantly held role as a responsible person of reference and working standards till end of my working day.
Successfully optimized the “multi-step route of synthesis” of “Achillion project”
Worked in “clean area” for Achillion project and handled production scale batches with proper GMP practices.
Achillion project, handled KG level batches filtration by using bulk size “Centrifuge filtration equipment” in production
Achieved many “reduction reactions” (pressure reactions) of “Achillion” project using “ Autoclave instrument” as per defined “Standard Operating Procedure of autoclave instruments”
Achillion project, successfully achieved good separation of critical intermediate steps using lab scale “Preparative HPLC technique” and production scale “Column Apparatus Technique”
Novartis project, successfully three years worked as an FTE (Full time employee) and achieved many targets on time and obtained appreciation from “Novartis clients”.
Novartis project, successfully completed yearly minimum two projects and shipped to client.
Novartis project, optimized route of synthesis of new molecules using different techniques such as “Parallel synthesizer” (To perform multiple reactions at a time ), “Isolera instrument” (Preparative HPLC-purification technique), “Rotary vacuum dryer” (Material drying), “ Manual filtration equipment” (Reaction mass filtration), “ advanced mass separation technique” (Used to separate two different density solvent in the reaction mass), etc.
Novartis project, successfully completed project targets before the timeline and got “best performer award” from organization as well as “Team award” from client.
Novartis project, got appreciation from global EHS (Environmental Health and Safety) head for handling and controlling of “fire accident” in the lab premises as a lab EHS in-charge.
Successfully held roles as “LAB EHS coordinator ”, “Lab housekeeping in-charge” and “Lab cold room in-charge”
Certifications
Successfully completed training on “Safe Operation of the Contained Fume Hood” held at Syngene International Limited (A Biocon company), December 2014.
Successfully completed course in “Six Sigma Green Belt” (SSGB) from Institute of Fundamentals in Quality, Pune, India.
Pursuing the PMP course from Udemy (Joseph Phillipe's) online tutorials which is approved by PMI.
Languages Known:
English
Hindi
Telugu
Kannada
Awards:
Achieved certificate of excellence for the contribution towards turning around a critical project with their stupendous effort and determination from Syngene International Limited (A Biocon company), January 2015.
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