My wife thinks that I have finally cracked. She believes that my affliction derives from too many years of opening envelopes or that I am feeling the strain of the many resumes I have read at night by the glow of the computer. Her concerns escalated just the other day, when she caught me reading my son bedtime stories that I had written for him about the job market. As I told her, I was just trying to teach him at an early age how to market himself into a good job. With all the competition out there, I want this boy ready when the time comes ...
Once upon a time, there were two interesting resumes which both wanted to attract the attention of Nancy Smith, assistant hiring manager at ABC Biotech. The first resume, a handsome six-pager in a gray envelope, said to the other, "I'm going to puff myself up real big and strong, and make it impossible for Nancy to miss me in that large stack." The second resume thought that this kind of behavior was inappropriate, but was too polite to say anything at first. But it thought for a minute, and then with a determined look said, "I'm going to cover myself with a short, powerful letter to Nancy so that she gets interested before she picks me up." The first resume laughed, and said in its most sarcastic tone, "What a silly little thing you are to think that a simple cover letter could make that kind of a difference. You're just a skinny, unattractive resume in a plain envelope. In fact, you won't even get a second look."
That morning, as the assistant hiring manager worked her way through the daily mail her eyes were drawn to the first resume, which stuck out from the pile in its gray pinstripe envelope. She opened the envelope and started to skim down the first page of the resume. "Gee, this resume has a lot of style and format, but not much content," she thought. The cover letter was of the mass-produced variety, simply restating the obvious education and credentials. After spending only a moment or two on it, Nancy set it aside with the others for filing. She continued opening the mail and skimmed a few other resumes in the same perfunctory manner. She stopped, however, when she came to that second resume, which included a letter personally addressed to her. "What an interesting package. This one hit the nail on the head. The cover letter describes our problem exactly, and then points out some accomplishments to look for in the resume. I'm going to read further on this one," she thought.
The little resume beamed, knowing that once an assistant hiring manager gets hooked, the story is almost certain to end "and they all lived happily ever after ..."
Let's face it, cover letters are read and resumes are skimmed. In light of this, why is it that so many of us put such little effort into writing the cover letter? For most people, this is because they incorrectly believe that the cover letter is a throwaway, and that the resume or CV inside that envelope is what counts. Although it is entirely true that the resume has to be well written and have good content, the cover letter's job is to point to what lies inside, and to make it more specific to that reader. Just like the cover of a magazine.
Can you imagine how much fun it would be to browse the newsstand if every magazine on the shelf looked alike? Instead, the cover shows you what lies inside and summarizes some of the key things that you will find there.
Although we are allowed to put more into a cover letter than can appear on a magazine cover, the challenge is still to keep it succinct. In fact, writing something that is powerful and yet short is the single most difficult kind of business writing. You already know that although it's easy to go on and on in a company memorandum, saying the same thing in half the space can make your work twice as powerful. And that's what you'll have to focus on in the cover letter for your resume package. You'll have three or four paragraphs at the most, on one page, and you'll need to get the interest of the professional reader of these documents who spends an average of no more than 2 minutes on each resume.
Here are the three important areas to consider as you write a good cover letter:
Appearance. Some of the reminders that I have for you deal with the way that your package looks and the appearance of the letter. But your first concern should be to make certain that your multipage CV has enough postage on it. Twice a week we have to pay for postage that was shorted by people who believe that anything that fits into a #10 envelope will mail for 37¢. What a terrific impression these folks make when the company has to pay the postage due on their application!
The quality of your stationery, the presence or absence of typographical errors, and other details of your letter's physical appearance combine to reveal your taste and style. It is only when style becomes all-important, as in my fable above, that it can hurt you.
Don't forget that cover letters are often scanned along with the CV or resume. Make sure that you have used common fonts and that you have avoided italics and underlining.
Using personal stationery for the cover letter is a classy touch. Stationery is usually on high-quality cotton content paper, one size smaller than the 8.5" x 11" size of the resume. Generally, ivory or white paper looks the most professional.
Never try and save time by using a window envelope. Many a resume has ended up in the accounting department because of this blunder.
Format. A form letter introduction--one that attempts to make the same letter work for all recipients--is a shortcut to disaster. The impression such letters inevitably create, particularly those that are photocopied, is that the writer has embarked on a resume-mailing campaign to every biotech and pharmaceutical company in the Western Hemisphere. Instead, develop a personal letter to a hiring manager or personnel authority at the company. Research the company well enough so that you can fine-tune your comments in the cover letter to specific issues that they are facing. For example, if you are targeting a regulatory affairs position, and you see that the company has a major product going into the clinic soon, you'll know to describe your technical writing experience and your ability to assist them with this registration process.
A workable format: The first paragraph should introduce who you are and where you work; the second paragraph should refer to one of your most appropriate accomplishments; and the closing paragraph should suggest some sort of action or describe your availability to interview.
If you have trouble getting that middle paragraph about the accomplishment into a brief statement, try using a challenge-approach-results format. State the problem you were faced with (one or two sentences), the approach you used to solve it (one or two sentences), and finally what happened as a result (one or two sentences). Voila, you've got a paragraph!
Content. Henry Ford once said, "If there is any one secret of success, it lies in the ability to get inside the other person's point of view and to see things from his angle as well as your own." That's why, as stated above, you must specifically identify something in your background or in one of your achievements that best relates to the company's issues. Often the ad you are replying to is a give-away, and yet people neglect that important information. If the ad refers to cell culture experience, do not spend that important middle paragraph describing your experience with E. coli. That's why it's generally not a good idea to customize your letters by simply changing the name and address at the top.
Although it is OK to use some "boiler plate" copy, don't waste the opportunity to get your message fine-tuned to the job at hand.
Don't use words that are uncomfortable for you or that you wouldn't use in conversation. As an example, "My resume is enclosed for your perusal" should probably read, "My resume is enclosed for your consideration."
Avoid creating what professional writers call "I-strain." This refers to the constant use of the word "I," which can get very tedious in a cover letter, almost to the point of making you appear self-centered. After you write your letter, go through it to remove a few extra "I's". Instead of writing a closing comment like, "I can be reached after 7:00 p.m.," you could make it "You can reach me any evening after 7:00 p.m."
Will There Be More Sappy Fairy Tales?
No worries. My wife has convinced me that our son needs time to be a boy before he needs to start thinking about his approach to the job market. My career as the author of children's stories about the biotechnology job market officially comes to an end with this month's column.
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.
Looking for job listings? Check out our Regulatory Affairs Specialist Jobs page.
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
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.
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.
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
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
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.
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.
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.
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
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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