Regulatory Affairs Resume Cover Letter

Regulatory Affairs Specialist Resume Samples

Regulatory Affairs Specialists work in regulated industries, such as energy, telecom, banking, or health care industries. These professionals need to ensure that their companies follow all regulations in the field and advise executives on the regulatory climate they need to consider when making decisions. Top resume samples for Regulatory Affairs Specialists highlight thorough knowledge of regulations, excellent communication skills, teamwork, time management, and computer competencies. A Bachelor's Degree in a relevant field is common experience in Regulatory Affairs Specialist resume examples.

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1

Regulatory Affairs Specialist

Managed an international team of regulatory affairs personnel to develop a global registration process, which led to the registration of over 4,000 products worldwide for a corporate rebranding project

  • Led the registration initiative during two $200M+ acquisitions
  • Developed a project strategy to ensure that the registration needs of various countries were met, risks were minimized, and domestic and international product-submittal processes were streamlined
  • Generated regulatory documents including Technical Files, Declarations of Conformity, Certificates to Foreign Government, and Certificates of Origin used for global product registration
  • Partnered with global and regional marketing teams to develop regulatory and global registration plans
  • Documented and maintained oral and written communications with global regulatory agencies
  • Assisted in the development and maintenance of regulatory files, records, and reporting systems
2

Regulatory Affairs Specialist

Provided Post-Market support for approved Class III and 510(k) products.

  • Create submission strategy and authored reports for FDA and other international agencies.
  • Served as a Regulatory representative in project teams, and provided regulatory support (strategy) for new products/therapies and modifications to existing products.
  • Authored and prepared FDA submissions: PMA, PMA-S, Real time review, Device Defect reports, and Annual reports.
  • Supported regulatory compliance activities for post market vigilance reporting (MDR), and product recalls.
  • Updated all Endovascular IFU and labels to meet FDA and international requirements.
  • Authored the Post-Market section of the Regulatory Affairs Professionals Society (RAPS) 2010 Study Guide.
3

Regulatory Affairs Specialist

Submitted dossiers to renew and obtain marketing authorisation licences on drug products.

  • Communicated with manufacturers, requesting additional information based on meetings with Health Authority experts.
  • Compiled tables on drug products to keep track of the product portfolio.
  • Evaluated key issues for discussion and negotiated with Health Authority experts to clarity questions.
  • Requested data from the manufacturing site and submitted the updated version of the dossier to Competent Authorities.
  • Arranged and indexed correspondence and approved documentation on drug products, archiving copies of submitted files.
4

Senior Regulatory Affairs Specialist

Managed the company's entire OTC pharmaceutical Vision Care (NDA and monograph) portfolio as well as select prescription generic (ANDA) and pharmaceutical (NDA) drugs.

  • Provided regulatory support for the implementation of filing strategies for new markets in South America, Europe, Africa, and Asia to expand the global footprint of the company.
  • Pharmaceutical regulatory CMC representative for local change boards as well as global change boards within the company.
  • Responsible for preparation of Module 3 documentation as well as the compilation of CMC Module 1 documentation for new markets.
  • Created and implemented regulatory tracking systems responsible for tracking of all pharmaceutical CMC submissions within the Global Regulatory Affairs department.
  • Tracked and maintained all regulatory deficiency correspondences and maintained the tracking of global regulatory requirements.
  • Prepared Annual Reports for assigned products and Annual product reviews for all products
5

Regulatory Affairs Specialist

Interacted with federal, state and international regulatory bodies supporting inspections and quality system audits

  • Reviewed and edited Quality Management System policies and procedures, and design history files for clarity, accuracy and compliance with US, Canadian and European regulations as well as ISO 13485, ISO 14971 and IEC 62304 standards
  • Ensured facility and product registrations, product recalls and investigations were documented and maintained appropriately to help ensure a constant state of inspection readiness
  • Provided regulatory guidance to product development teams and drove strategic regulatory implementation via proper design controls throughout the product development process
  • Determined regional labeling requirements; reviewed and approved final labeling and packaging
  • Prepared investigational reports for field corrections, post-market surveillance and MDR events
  • Reviewed customer complaints for safety issues; non-conformances and CAPAs for effectiveness
  • Obtained and managed required state, federal and international licenses for Rx device distribution
  • Assisted with the planning and preparation of 510(k) and international submissions (i.e., HC, COFEPRIS)
  • Coordinated annual safety inspections, OSHA Form 300 reporting and incident response, managed environmental health and safety (EHS) program
  • Led initiative to improve employee training compliance, increasing training from 55% to >90% completion rate
6

Regulatory Affairs Specialist

Coordinated IRB submission and implementation of approved studies for neurological disorders at 3 sites (Miami Beach, Fort Lauderdale, and Boca Raton).

  • Maintained regulatory binders for over 150 clinical research trials.
  • Prepared and maintained approved studies for compliance with the FDA, IRB and sponsors requirements which includes IND Safety Reports, SAE Reports, protocol deviations and FDA 1572 forms.
  • Performed QA of all regulatory documents before submission to IRB and Sponsor.
  • Communicated study status to sponsors, PI's and clinical staff. Distributed all incoming regulatory documents to Study Coordinators and / or Investigators.
  • Maintained Informed Consent Form files for clinicians.
  • Prepare and maintain monthly monitor (CRA visits) calendar for all three sites.
  • Assist Manager in the creation of new policies and procedures for departmental operations. Developed and implemented system for incoming study communication.
7

Sr. Regulatory Affairs Specialist, Medical Devices

Provided Regulatory Medical Device Reporting (MDR) support to Division and Affiliates for [company name] Medical Device products marketed globally.

  • Conducted MDR Regulatory Assessments and filed U.S. FDA MedWatch Forms.
  • Responsible for U.S. FDA and Global Government Agency/Notified Body inquiries.
  • Organized and led Global Forums with Affiliates to cultivate learning and communication.
  • Created and updated Operating Procedures, and led Malfunction Review Board.
  • Responsible for preparing and presenting customer complaint and MDR metrics to management.
8

Global Regulatory Affairs Specialist

Prepared traditional and abbreviated 510(k)s; supported PMA submissions.

  • Compiled WorldView global regulatory strategy country reports focused on medical devices.
  • Developed contacts with Health Authorities worldwide, specifically medical device divisions.
  • Led multiple research projects to assist companies in obtaining market clearance worldwide, including IVD
  • Efficiently prioritized and completed several projects simultaneously.
  • Co-wrote "Overview of EU Medical Devices Directives Updates", published in Regulatory Focus September 2010.
9

Regulatory Affairs Specialist

Prepared international product registrations in Latin America (Brazil, Argentina,
Chile, Colombia, Nicaragua, Venezuela, and Mexico)

  • Drafted international dossiers for 510(k) and PMA electric cardiovascular devices
  • Led Division's projects of supporting China SFDA registrations/re-registrations
  • Performed Product International Registration Release (IRR)
  • Support International Business Center for the need of dossiers for product
  • Prepared and requested CFGs
10

Regulatory Affairs Specialist

Monitored and coordinated Compliance Programs and legislative issues including legislative and managed care policy initiatives

  • Monitored contract compliance to include monthly, quarterly and annual reports to State agencies
  • Acted as Liaison to internal departments, including training and problem resolution
  • Responded to State inquiries and complaints
  • Monitored and coordinated local internal policy and procedure development and implementation
  • Provided staff support to Compliance Oversight Committee
  • Supported expansion activities to serve new geographic areas or populations

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Bring drugs to market’, stakeholder management’ and ‘strategic input

are probably some of the phrases the internet bible, that is google, flagged up during your search of what a RA professional does. How does that translate into what the daily activities of a RA professional are, I hear you cry? Well sit back, relax and make yourself comfy for at least the next few minutes, as I will attempt to give you an idea of what you are signing up for when you submit your application before the 8th Feb.

Before I continue I have a little confession to make, whilst I am a RA graduate my first rotation is actually within Chemistry, Manufacturing and Control (CMC) Supply. One of the many beauties of the graduate program is the rotational element; one of your 8 month rotations will be outside of RA, but in a department closely aligned to RA, which leads me nicely into my next paragraph…

CMC Supply

CMC supply is a pretty awesome place to work because:

A) One day you may go into work to see an ice cream machine in the coffee room, which signals you to start salivating like one of Pavlov’s dogs

B) Following the arrival of said ice cream machine, your department manager may tell you to ‘help yourself to as much ice-cream as you want’ (adios waistline)

C) CMC Supply is the heart of the formulation and development of our drug products. In a nutshell, we are the middle men and women between our research laboratories discovering a novel drug product that can kick the ass of diabetes (and other other chronic disorders), and our colleagues in product supply, who manufacture the drug on a commercial scale to then ship to patients across the globe.

This was no mirage, there was an ice-cream machine in my office!

Now I should really get on with telling you a little about what I actually do:

’Bring drugs to market’

Think less breaking bad and more Phase 3 drug development, with the latter being a pivotal stage in the ‘bring drugs to market’ concept. In Phase 3 you compile and submit all your documents to health authorities as part of a new drug application (NDA). The NDA essentially proves that you have the coolest drug product out there, bar none. Recently, I authored one of the first documents from our department to be submitted to the FDA as part of the NDA. Thus highlighting that you get real responsibility from the get go and a real chance to apply yourself. However, it must be noted that such a task could not be completed alone and I was able to get by with a little help from my friends -not Paul McCartney and Co, but my stakeholders.

‘Stakeholder management’

Whether I am relying on a chemist in my department to review a protocol  I am writing, to ensure it is scientifically viable or a colleague in analytical support to give me input on validated methods used to test the stability of our drug product; stakeholders and their input is key to your day-to-day work. Don’t be surprised if you can sometimes spend the best part of a day in meetings with your stakeholders or find yourself negotiating deadlines for their input. I am quickly learning that if you manage your stakeholders well, you have won half of the battle in finalising a task you are responsible for.

‘Strategic input’

Recently I tried my hand at being strategic during the writing of a protocol for a study that confirms our drug product is degraded in light and hence must be stored away from light. Sounds simple right? Well not so simple, as we need to decide on what stability indicating test parameters we want to investigate. To cut a long story short, I made a suggestion of not including some test parameters in the submission package as part of that NDA application I told you about earlier, but still testing said parameters and keeping them in house in case FDA has questions around them. Apparently, this is a good suggestion and considering up until now, the most strategic thing I had done involved me placing hotels on the orange property set of the monopoly board and bankrupting my whole family in the process (sorry guys), I think it is safe to say I am learning and reaching new strategic heights.

It’s like looking in the mirror.

For me to be able to help in the process of bringing drugs to market, whilst managing various stakeholders and trying to give some strategic input from time to time I have been trained and continue to receive ample training to aid my development. Training will be the theme of my 4th blog post, so stay tuned folks :)

 

Tags: Career, Career path, Experiences, First rotation, Fun at Work, Graduate Program, Graduate programme, My Story, Regulatory Affairs

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