Director, Regulatory Affairs and Compliance Resume Example
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DIRECTOR, REGULATORY AFFAIRS AND COMPLIANCE
Professional Summary
Motivated and dedicated Head of Regulatory Affairs and Compliance with BS in Chemistry and Biology, and 11+ years of
Pharmaceutical Regulatory Affairs experience. Proven ability to oversee the
overall operation of the Regulatory Affairs and Compliance Department. Varsity knowledge of product development process and lifecycle (IND, AND /NADA, ANDA/ANADA) and post-approval regulatory requirements (CBE, CBE30, PAS) supported by 5 years of analytical pharmaceutical testing requirements, analytical process and method validation / requirement experience.
Skills
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Work History
Director, Regulatory Affairs and Compliance, 04/2015 to Current
Company Name – City, State
Company Name – City, State
- Lead and direct the Regulatory department, clients and consultants on project timelines, review and timely electronic submission of Regulatory documents.
- Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
- Proactively communicate CMC regulatory strategy, key issues and any other critical compliance matter to shareholders.
- Handling all customer complaints, conducting investigations, resolution and electronic filing of each complaint.
- Preparing written and verbal Customer Change Notifications of API / Intermediate product manufacturing changes and discussing the impact of the proposed changes with all customers.
- Work with API and Intermediate suppliers to prepare timely and Complete Responses to Regulatory Agency Deficiency Letters.
- Communicate with FDAs CDER and CVM officials on relevant matters concerning submission and act as a point of contact for all Regulatory and Compliance matters.
- Assist clients with the planning, execution and implementation of product Manufacturing Change Controls.
- Coordinate with API suppliers to ensure timely submission of SPL product Registrations, Annual Establishment Registration, GDUFA Facility Registration and timely GDUFA payment, as required under the FDA GDUFA law.
- Manage Supplier Quality, Supplier CGMP Auditing, Supplier Certification, and internal and External Auditing.
- Assist in developing SOPs to ensure Quality and Regulatory compliance.
- Responsible for employee cGMP training and Annual / periodic cGMP training.
- Keep up to date on Regulatory Changes, including new Regulatory Agency Guidance and Revisions, Changes to USP Pharmacopoeia, EU Pharmacopoeia and communicated the changes to Suppliers for comments and updating of affected changes / or implementing the new requirements.
Regulatory Affairs CMC Associate Manager, 10/2013 to 11/2014
Company Name – City, State
Company Name – City, State
- Supported global Regulatory Authority submissions, identified the required documentation and negotiated the delivery of approved technical source documents in accordance with project timelines.
- Conducted regulatory review of source documents for Regulatory Authority submissions, including the review of content, quality and timeliness issues with source documents, or authoring issues that may impact submission quality or timeline and communicating this to relevant personnel.
- Supported the Drug Regulatory Affairs Compliance (DRAGON) database and acted as a single point of contact for database entries and compliance issues.
- Performed review of clinical Supply Evaluation Forms for clinical trial studies.
- Coordinated and prepared responses for customer medical inquiries and general product inquiries.
- Kept knowledge of up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
Senior Associate Regulatory Affairs (CMC), 11/2007 to 08/2013
Company Name – City, State
Company Name – City, State
- Prepare post approval CMC Regulatory submissions and supplemental applications such as CBEs, CBE-30 and PAS.
- Responsible for timely submissions of Annual Minor Changes and Stability Reports for the approved products.
- Coordinate the receipt of documents, compile and submit documents for the Veterinary Master Files (VMFs).
- Prepare and submit to CVM, Annual Antimicrobial reports for the approved products under ADUFA Section 105.
- Facilitated the FDA electronic submission implementation at PAH, including preparation and submission of Structure Product Labeling (SPL), NDC Drug Listing and Establishment Registrations.
- Coordinated interdepartmental meetings to discuss FDA Incomplete / Deficiency letters, coordinated the receipt of documents and prepared Response Package for management review and submissions.
- Participated in interdepartmental meetings and meetings with Phibro's subsidiaries to discuss product and manufacturing changes and the regulatory impact.
- Prepared applicable Standard Operating Procedures (SOPs).
- As a member of the Animal Health Institute (AHI), attended quarterly meetings, webinars, teleconferences and discussions with other AHI members and FDA officials on various regulatory topics.
- Participated in the AHI Working Groups to increase knowledge of current FDA activities, regulations and their impact on the Industry.
Regulatory Affairs Associate, 11/2005 to 11/2007
Company Name – City, State
Company Name – City, State
- Review documents such as DMF submissions for completeness and accuracy.
- Coordinate customer Audits and FDA inspections of our principal foreign API manufacturers.
- Assisting Regulatory Manager with internal Audits.
- Handle and resolve any incoming product discrepancies with the API manufacturers.
- Register foreign manufacturing facilities with FDA and submit to FDA, product NDC listing on behalf of our foreign API manufacturers.
- Keeping abreast of world-wide Regulatory procedures and changes that may affect products we supply.
- Reviewing Regulatory Agency publications for any information that may affect the products we supply, and reviewing bi-monthly Pharmacopoeia for any changes that can affect analytical testing and specifications.
- Informing manufacturers of these changes as appropriate.
- Issuing DMF Letter of Authorization to customers on behalf of our foreign manufacturers.
- Reviewing customer specifications with the manufacturer's specifications and methods for comparability to ensure the material we supply complies with customer's requirements.
- Handling and resolving customer complaints related to product quality and safety.
- Responding to daily technical requests from customers and coordinating answers with manufacturers.
- Reviewing and assembling new and updating existing Technical packages.
- Arranging and participating in conference calls between customers and manufacturers to discuss Technical and Regulatory issues related to the products we offer.
- Keeping and maintaining Regulatory record of all activities.
- Assist in resolving technical issues such as Out Of Specifications results.
Senior QC Chemist, 01/2003 to 10/2005
Company Name – City, State
Company Name – City, State
- Perform pharmaceutical analysis on finished, stability and raw material products by USP, NF and In-House Test methods utilizing HPLC, UV, FTIR and GC methods.
- Conducted dissolution tests, Assays, and content uniformity tests on finished solid dosage tablets and capsules.
- Perform wet chemistry and physical tests on raw materials (Identification by UV and TLC) heavy metals, moisture tests, Particle size, Bulk and tapped density tests.
- Prepare and standardized test solutions, volumetric solutions and reagents.
- Trained other chemists on methods and techniques.
- Audit lab entry logbooks and solution notebooks.
QC Chemist, 01/2002 to 01/2003
Company Name – City, State
Company Name – City, State
- Documented all activities in notebooks and logbooks, maintained lab equipment and calibration according to established procedures, ensuring all lab Practices are in compliance with SOPs and cGMPs.
- Performed USP Pharmaceutical Analysis and In-House Analytical Assays, Content Uniformity, Related substances and Impurity, Dissolution and Dissolution profile tests on In-process Materials and Finished Drugs by appropriate methods such as HPLC, UV/VIS, FTIR and TLC,.
- Raw material Analysis by TBD & PBD, and KF auto titration tests.
- Performed cleaning validations through analytical testing to determine residual pharmaceutical ingredients and cleaning agents on pharmaceutical equipment.
- Conducted routine environmental/water sampling for Microbiological Tests and performed Analytical testing of Conductivity and Chlorine.
- Performed chemical and physical calibrations on analytical equipment.
- Conducted method transfer from R& D and validated these methods for QC testing.
- Documented all activities in notebooks and logbooks, maintained lab equipment and calibration according to established procedures, ensuring all lab Practices are in compliance with SOPs and cGMPs.
- Participated in peer review and verifying compliance of notebook entries according to.
Junior Chemist, 11/2001 to 01/2002
Company Name – State
Company Name – State
- Formulated and batched Hair Care products (Shampoos, conditioners and hair sprays).
- Monitored and recorded stability of bench formulated products.
- Assessed and compared performances of sample prototype hair care products in salon testing.
Education
Bachelor of Science: Chemistry and Biology, 2001
New Jersey City University - City
New Jersey City University - City
- Continuing education with a double major in Chemistry and Biology
- Professorial assistant and tutor in Genetics
- Member of Chemistry club, conducting academic coursework research in drug discovery and presenting the study and results in the Chemistry Symposium
- Coursework in Cell and Molecular Biology
Accomplishments
- Reduced department operating costs by 30% in 3 years by initiating electronic filing and submissions of Regulatory documents to health authorities.
- Increased company revenue by $15,000 /yr by negotiating an in-house implementation of SPL Drug Listing and Establishment Registration function, previously outsourced
- Tactfully handled Technical questions from customers and offered resolutions within a negotiable time period
- Resolved customer complaints to the customers satisfactory
- Successfully mentored and coached staff to ensure adoption of new programs
Interests
- Reading / book club
- Physical Fitness
- Hiking, Tennis, Basketball
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Resume Overview
School Attended
- New Jersey City University
Job Titles Held:
- Director, Regulatory Affairs and Compliance
- Regulatory Affairs CMC Associate Manager
- Senior Associate Regulatory Affairs (CMC)
- Regulatory Affairs Associate
- Senior QC Chemist
- QC Chemist
- Junior Chemist
Degrees
- Bachelor of Science : Chemistry and Biology , 2001
