The role of regulatory affairs is to develop and execute a regulatory strategy to ensure that the collective efforts of the drug development team results in a product that is approvable by global. Regulatory affairs associate resume samples jobhero. Regulatoryaffairs specialists can aspire to, among other positions, the following. Top resume samples for regulatory affairs specialists highlight thorough knowledge of regulations, excellent communication skills, teamwork, time management. There is evidence of consistent successes in new product registrations, process. Curriculum vitae profile professional experience senior.
Regulatory affairs associates work in the healthcare products industry and help releasing new products by conducting government approval processes. They are often employed by pharmaceutical, biotechnology, and medical device companies. We are seeking a regulatory specialist who will be responsible for the planning and creation of required regulatory documentation during and after. Apply for the job in regulatory affairs associate at mountain lakes, nj. Professional experience consultant selfemployed regulatory affairs 2008current provide expert consulting services in regulatory affairs, submissions, compliance, product development, regulatory strategic assessments. Sas, ibm spss, phlebotomy, excel, academic research. This role will report directly to the vice president, regulatory affairs and quality, and be instrumental to the growth and success of our department and company. Regulatory affairs manager oversees the regulation process for products requiring governmental approval, including filing necessary applications and handling all government interactions.
Job description and duties for regulatory affairs manager. Regulatory affairs specialist resume sample pdf ebook free download. A global regulatory professional with twentytwo years clinical drug development experience, seventeen of which within global regulatory affairs. Find 100% professional regulatory affairs resume examples to help you build your resume in 2020. Exemplar360 hiring regulatory affairs specialist in. Ns vyawahare, drug regulatory affairs, third edition 2015. These personnel analyze new and existing regulations in relation to an organizations products or processes.
Regulatoryaffairs specialist pharmabio developpement. Regulatory affairs specialists assist in obtaining and maintaining government approval for drugs, medical devices, nutritional products, and related materials. Profile strong regulatory background includes knowledge of current federal guidelines, fdausda regulations, sop preparation, streamlining of. Crafting a regulatory affairs specialist resume that catches the attention of hiring managers is paramount to getting the job, and livecareer is here to help you stand out from the competition. There are plenty of opportunities to land a regulatory affairs specialist job position, but it wont just be handed to you.
Our certified professional resume writers can assist you in creating a professional document for the job or industry of your choice. Proactive, resultsdriven professional with excellent years of experience working in the healthcare field in the capacity of a quality assurance officer, and a medical technologist. The regulatory affairs engineer will ensure that the quality, safety, health and environment systems continues to meet fda, iso, mdd, mdr, cmdcas, epa, osha and other appropriate international. Regulatory affairs is a comparatively new business administration function. The scope of regulatory affairs in the pharmaceutical industry. Scranton, pa 18503 5555555555 email job objective regulatory affairs specialist seeking position with a wellestablished organization where my experience can be used for the wellbeing of the company. Phd career guide discusses some of the roles, entry points, career progression, and compensation expectations for careers in regulatory affairs. There are over 5,499 regulatory affairs careers waiting for you to apply. Regulatory affairs specialist resume sample livecareer. Regulatory affairs liaisons manage the process of working with project teams and interacting with the regulatory health agencies, such as the food and drug administration fda or the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use ich. A competent scientist with research and regulatory affairs experience as well as the ability to support a complex matrix organizational environment. Regulatory affairs specialist cv template cv samples. Use this regulatory affairs specialist cv template as the starting point for your own jobwinning cv.
Professional regulatory affairs specialist templates to. The successful candidate will be an integral member of a small regulatory team, and work closely with a crossfunctional development team and external partners. Save your documents in pdf files instantly download in pdf format or. The organisation for professionals in regulatory affairs. Regulatory affairs specialists have expanded as a result of company acquisitions and restructuring, worldwide globalization of markets, and everevolving regulations. Crest clinical research 72006 112008 2004 2008 managed 50 multidisciplinary scientists within the global regulatory affairs department as part of a worldwide expansion to grow the regulatory business. Austin vita hiring regulatory affairs specialist in orange. The regulatory function is vital in making safe and effective healthcare products available worldwide. Regulatory affairs manager job description, duties and jobs.
Regulatory affairs associates for dummies what you need. In fact, 25 cents of every dollar spent by american consumers go toward a product or service regulated by the food and drug administration fda. Regulatory affairs specialist resume great sample resume. As a regulatory affairs officer youll be the crucial link between your company, its products and regulatory authorities. With lots of options, it can be intimidating to choose the right path. Proficient in english, bulgarian, and russian languages. Since every step in the process of product development is highly regulated, those in ra work at each step to move a drug from research and development through fda approval. The main objective of regulatory affairs is to provide the basis for the assurance of high quality of food products which. See more ideas about regulatory affairs, clinical research and life science. Customise the template to showcase your experience, skillset and accomplishments, and highlight your most relevant qualifications for a new regulatory affairs specialist job.
Dentsply regulatory affairs manager 62423 job opening in. Regulatory affairs specialists play a key role in ensuring that their company complies with applicable regulations. Regulatory affairs specialist resume samples jobhero. Achieved targeted growth domestically and internationally.
Regulatory affairs an overview sciencedirect topics. Pharm, pgdipr, pgddra international regulatory affairs dept. A company offer letter is offered to the candidates who have been selected after interview. Regulatory affairs department is an important part of the organisational structure of pharmaceutical companies. The office of regulatory affairs is considered one of a companys strategic pillars. Common work activities listed on a regulatory affairs associate resume sample are ensuring compliance with industry regulations, collecting scientific data. These general studies pathways include four core courses that are. Apply to intern, operations intern, summer associate and more. Regulatory affairs ra professionals play critical roles in a pharmaceutical industry because it is concern about the healthcare product lifecycle, it provide strategic, tactical and. A welldrafted regulatory affairs specialist resume contains the following duties and roles studying and understanding the legal or scientific documents, ensuring compliance with regulations set by mhra, overseeing product trials and regulatory inspections, negotiating and liaising with regulatory authorities, and ensuring quality standards. View hundreds of regulatory affairs specialist resume examples to learn the best. Regulatory affairs within the biomedical and health products sector is a relatively young, multidimensional profession that is international in scope. 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. The duties and responsibilities of regulatory affairs specialists have expanded in recent years as a result.
Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals. Clinical research regulatory affairs quality systems biomedical engineering 9445 minnetonka blvd. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. Senior regulatory affairs resume samples and examples of curated bullet. Apply to regulatory specialist, quality assurance analyst, regulatory affairs talent community remote and more. A pharmaceutical regulatory professional with experience extending from drug discovery to latephase development familiar with strong experience, knowledge and leadership skills in project management regulatory strategies and filings process optimization new product development cro outsourcing risk management budget. Their job is to oversee the processes involved in ensuring compliance. How to get a job in regulatory affairs proclinical blogs. Apply to associate, regulatory specialist, entry level associate and more. Sample resume for regulatory affairs position college recruiter.
Jan 18, 2016 sample regulatory affairs specialist resume. Common work activities listed on a regulatory affairs associate resume sample are ensuring compliance with industry regulations, collecting scientific data, handling license submissions, updating. Internally it liaises at the interface of drug development, manufacturing, marketing and clinical research. The regulatory affairs manager is responsible to ensure delivery of the safest and highest quality products while maintaining full regulatory compliance. These departments can be found in a variety of companies that manufacture pharmaceuticals, drugs, medical devices, cosmetics and industrial chemicals. Since its establishment in 1968, temples regulatory affairs and quality assurance program has played a significant role in training pharmaceutical company personnel in regulations and quality principles and practices.
Represented the ehs department at sap integration project design and. Regulatory affairs also has a very specific meaning within the healthcare industries pharmaceuticals, medical devices, biologics and functional foods. Regulatory compliance specialist, 102015 to 062016 bristolmyers squibb new brunswick, nj. May 30, 2015 top 8 regulatory affairs assistant resume samples in this file, you can ref resume materials for regulatory affairs assistant such as regulatory affairs assist slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Use our job search tool to sort through over 2 million real jobs. Created and submitted regulatory applications and notices of work completions. We will use your resume to quickly build your profile and apply to this job. Regulatory and clinical affairs careers office of career. Explore regulatory affairs executive openings in your desired locations now. Weve laid out these pathways to help you with a starting point.
Broad experience across various therapeutic areas including cns, antiinfective, ophthalmology, gugi, respiratory and oncology. Clinical research regulatory affairs quality systems. Top resume samples for regulatory affairs specialists highlight thorough knowledge of regulations, excellent communication skills, teamwork, time management, and computer competencies. Regulatory affairs associate, 072016 to current cognizant technology solutions bridgewater, nj.
Regulatory affairs ra scientists are involved with overseeing the process of getting a drug through clinical trials and onto the market. Jul 30, 2014 the demand for regulatory affairs ra professionals is clearly evident across the pharma industry, consultancy companies, clinical research organizations and regulatory agencies. Regulatory affairs ra, also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. List the jobs essential most important functions and responsibilities. Coordinates inspection of the organization and contract facilities, and develops procedures to ensure regulatory compliance. A bachelors degree in a relevant field is common experience in regulatory affairs specialist resume examples. The regulatory affairs certificate program is an online series of courses you personalize to meet your professional development needs.
The lowstress way to find your next regulatory affairs job opportunity is on simplyhired. Regulatory affairs professionals society raps, regulatory career. The organisation for professionals in regulatory affairs explains on its website that a. Regulatory affairs and its role in pharmaceutical industry. Regulatory affairs associate job opening in mountain lakes. What they do regulatory affairs associates coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. Rac in us regulatory affairs raps, autumn 2011 education. Do you know what to include in your regulatory affairs specialist resume. Ra professionals come from a variety of disciplines such as law, academics, industrial research and medicine. Role of regulatory affairs in the pharmaceutical industry.
Regulatory affairs officers ensure the appropriate licensing, marketing and legal compliance of a range of pharmaceutical and medical products in order to control their safety and efficacy. Use our job description tool to sort through over,000 other job titles and careers. Each food, beverage, cosmetic, prescription medication, or vitamin you purchase has undergone rigorous regulatory checks for safety and efficacy on. I currently hold a masters degree in biology and have two years of experience working an fda regulated industry. View the job description, responsibilities and qualifications for this position. Whether you realize it or not, you cross paths with the regulatory affairs industry on a daily basis. Imported submission ready files from an electronic document management system into their specific module folders, file tagging, leaf title modification, bookmarking and hyperlinking, quality assurance and compilation. Regulatory affairs manager job description, duties and. Regulatory affairs a guide for prescription drugs, medical devices, and biologics second edition.
This resume was written by a resumemycareer professional resume writer, and demonstrates how a resume for a pharmaceutical regulatory affairs resume sample should properly be created. Regulatory affairs associates for dummies what you need to know in 15 slides 1. Toby freedman phd, in biotechnology entrepreneurship, 2014. Seeking regulatory affairs position for biopharmaceutical industry where more than three years of biological research and regulatory compliance experience will add value.
Regulatory affairs specialist resume format download resume pdf. Regulatory affairs associate resume example cognizant. Regulatory affairs establish common principles and responsibilities that provide a strong scientific database, efficient organizational arrangements, and procedures to underpin decision making for nutraceutical preparations. Regulatory affairs manager resume samples velvet jobs. Scranton, pa 18503 5555555555 email job objective regulatory affairs specialist seeking position with a wellestablished organization where my experience can be used for the wellbeing of the company highlights of qualifications. Sample regulatory affairs specialist resume regulatory. Regulatory affairs also has a very specific meaning within the healthcare industries pharmaceuticals, medical devices, biologics and. Some of the responsibilities of ra is writing and working in teams. Apply to 112 regulatory affairs executive jobs on, indias no. A regulatory affairs specialist ensures that businesses are in compliance with government regulations.
Regulatory affairs specialist in online resumes, cv. Chief medical officer resume sample medical affairs. Regulatory affairs associate resume samples qwikresume. Research salary, company info, career paths, and top skills for regulatory affairs associate. Guide the recruiter to the conclusion that you are the best candidate for the regulatory affairs manager job. Seeking to resume my career in regulatory affairs area. Let your resume represent your skills and qualifications to potential employers. Senior regulatory affairs resume samples velvet jobs. Built various submissions within ectdxpress for nda and ind applications. Please practice handwashing and social distancing, and check out our resources for adapting to these times. The individual who holds the position also manages the government and regulatory affairs department. Proven scientific, regulatory and managerial expertise in driving both early.
I have recently seen your notice regarding an opening for a regulatory affairs associate at your company fougera pharmaceuticals inc. The scientific background of phds is useful for the fda product approval process. Regulatory affairs specialist resume example livecareer. Scientific experience includes determining the mechanism of action, developing assays, preparation of scientific manuscripts and presentations at meetings.
Regulatory affairs specialist resume samples qwikresume. Responsible for the creation of product sdss and other safetyrelated documents covering all commercial and experimental products developed and sold under the various companies owned or affiliated with bristolmyers squibb. Verifiedadherence with regulatory reporting requirements for all phases of operations. Regulatory affairs specialists work in regulated industries, such as energy, telecom, banking, or health care industries. Regulatory affairs professionals society raps find your next career at. Use our career test report to get your career on track and keep it there. Regulatory affairs ra, also called government affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, agrochemicals plant protection products and fertilizers, energy, banking, telecom etc.
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