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Head Of Regulatory Affairs Job Description – The Regulatory Affairs Manager provides support in formulating and implementing regulatory strategies for generic oral solids product development and regulatory activities in accordance with US FDA and ICH guidelines.
To write an effective regulatory affairs job description, start with a detailed list of duties, responsibilities, and expectations. We have included regulatory affairs job description templates for you to edit and use.
Head Of Regulatory Affairs Job Description
Oversees the preparation and maintenance of regulatory filings and files for Wave 1 countries (US and EU) including US PMA submissions
Regulatory Affairs Specialist
Maintain and improve working knowledge of current/upcoming regulations and guidance for generic drugs and new drugs to ensure compliance with Regulatory Agency requirements
Monitors developments and evaluates the impact of new and proposed changes in laws, court decisions, litigation, regulations and enforcement activities affecting ingredient use, product safety, labeling and advertising.
Lead and manage activities related to product submission and approval and transfer to public regulatory bodies, including US and EU regulatory agencies
List any licenses or certifications required by the position: RAC, MDD, US, RAPS, MDR, FDA, CE, FTA, GMP, ETL
Regulatory Affairs Manager Resume Example For 2023
Employers who are hiring for regulatory affairs management jobs will most often prefer their potential employee to have a relevant degree such as a bachelor’s or master’s degree in science, engineering, chemistry, pharmacy, biology, technology, education, life science, medicine, life science.
Any material produced by patient organizations that is planned to be distributed by healthcare personnel representatives and any material for exhibition at meetings of patient organizations
Our innovative and growing company is looking for experienced candidates for the position of Regulatory Affairs Manager. Thank you in advance for looking at the list of responsibilities and qualifications. We look forward to reviewing your CV.
Our growing company is seeking experienced candidates for the position of Regulatory Affairs Manager. To join our growing team, please review the list of responsibilities and qualifications.
Freelance Local Regulatory Affairs Specialist
Our growing company is looking for a Regulatory Affairs Manager. Read the list of responsibilities and qualifications. Although this is our ideal list, we will consider candidates who do not necessarily have all the qualifications, but who have sufficient experience and talent.
Our innovative and growing company is seeking a Regulatory Affairs Manager. To join our growing team, please review the list of responsibilities and qualifications.
Our growing company is looking for a Regulatory Affairs Manager. To join our growing team, please review the list of responsibilities and qualifications. Regulatory Affairs provides guidance and support pages for implementing quality management systems for medical devices in accordance with the FDA’s Quality System Regulations (QSR) and other applicable ISO standards, including ISO13485, ISO14971, etc.
To write an effective regulatory affairs job description, start with a detailed list of duties, responsibilities, and expectations. We have included job description templates for regulatory affairs that you can edit and use.
Amn Life Sciences Hiring For Executive And Manager Regulatory Affairs
Carry out regulatory activities to ensure compliance with the FDA, Health Canada and UK MHRA and other regulatory agencies, including but not limited to
Communicate with FDA and HC or other regulatory authorities to monitor the progress of regulatory submissions, answer questions and ensure that registration approvals are granted without undue delay
Manages the case analysis process and implements new methods to identify patterns and trends related to important regulatory topics
List any licenses or certifications required by the position: RAC, US, FDA, ETL, UL, USDA, CE, RAPS, EU, GMP
Regulatory Affairs Jobs
Employers hiring for regulatory jobs will most often prefer their potential employee to have a relevant degree such as a bachelor’s and master’s degree in science, pharmacy, engineering, chemistry, technology, life science, biology, medicine, education, the store
Must be goal oriented, able to work in a cross-functional team environment, self-motivated and understand business needs to meet timelines
Knowledge of the product/process and the potential impact the change may have on the product design/verification and/or validation process
Our company is looking for employees for regulatory affairs. Read the list of responsibilities and qualifications. Although this is our ideal list, we will consider candidates who do not necessarily have all the qualifications, but who have sufficient experience and talent.
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Our company is growing rapidly and looking for regulatory conditions. If you are looking for an exciting place to work, check out the list of qualifications below.
Our company is looking for employees for regulatory affairs. We appreciate your taking the time to go through the list of qualifications and the application for the position. If you do not meet all the qualifications, you may still be considered depending on your level of experience.
Our company strives to fulfill the role of regulatory affairs. Thank you in advance for looking at the list of responsibilities and qualifications. We look forward to reviewing your CV.
Our growing company is seeking experienced candidates for a position in Regulatory Affairs. If you are looking for an exciting place to work, check out the list of qualifications below. Regulatory Affairs specialists assist in obtaining and maintaining regulatory approval of drugs, medical devices, nutritional products and related materials. They are often used by pharmaceutical, biotech and medical facilities. They may also work in government or law. The duties and responsibilities of regulatory affairs specialists have expanded in recent years due to corporate acquisitions and restructurings, globalization of markets around the world and ever-evolving regulations. Individuals in these positions typically work within the Office of Regulatory Affairs, where they work to prepare documents, manage information, maintain files, and coordinate tasks across multiple departments. Part of their strategic directive is to strike a balance between regulatory concerns, technology, marketing objectives, compliance, time to market and cost. The Office of Regulatory Affairs is a dynamic work environment where communication with employees at all levels of the organization is extremely important.
The Institute Of Chartered Accountants Of Bangladesh (icab),
Regulatory affairs specialists must understand all aspects of product development, including research, clinical trials, manufacturing processes, regulations and approval processes. They help review product promotional materials, labeling, batch records, specification sheets or test methods for compliance with applicable regulations and guidelines. They often advise project teams on areas such as pre-market regulatory requirements, export and labeling requirements, or clinical trial compliance issues. In addition, they determine what types of regulatory registrations or internal documentation are required in situations such as proposed device changes or labeling changes.
Various job titles may be used in this profession, including Clinical Quality Assurance Associate or Specialist, Drug Regulatory Specialist, Product Safety Specialist, Quality Assurance Coordinator or Specialist, Quality Assurance/Regulatory Affairs Specialist (QA/RA Specialist), Regulatory Affairs Analyst, and Regulatory Affairs Associate. Some typical job duties include:
Positions in regulatory affairs are increasingly responsible, and senior individuals typically assume manager or director titles. Jobs in this field are likely to increase as a result of increased public regulation in the healthcare and pharmaceutical industry.
Regulatory Affairs specialists must be able to work in a demanding environment where strict timelines and protocols must be adhered to. They often work with managing and documenting information and must be skilled with databases and other information management tools. Attention to detail is extremely important, as is the ability to adapt quickly to changing regulations. They must have good organizational, analytical, project and communication skills. They often collaborate with other employees and team members to coordinate complex activities, often with competing priorities. Most regulatory positions are full-time. Some may work in supplier or consultant roles related to a specific product. Others may be long-term roles covering a wider range of products. As they need to be up-to-date in their area of expertise, it is common to attend professional conferences or relevant educational events.
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Entry-level regulatory affairs professionals have a bachelor’s degree. Typical majors include biochemistry, life sciences, chemistry, pharmacy, pharmacology, toxicology, medicine, and engineering. Law, marketing, business and statistics courses are also useful. Those who advance in this profession often have a master’s degree (eg, in business administration, clinical research, engineering, or life sciences) or a graduate degree (eg, PhD, MD, or PharmD). Progress may require certification, for example through Regulatory Affairs Certification (RAC). The Director of Regulatory Affairs provides regulatory expertise for new strategic areas and technologies required for new product development, including areas of clinical research, CMC, regulatory operations, non-clinical study requirements and early development regulatory compliance expectations.
To write an effective director of regulatory affairs job description, start with a detailed list of duties, responsibilities, and expectations. We’ve included director job description templates, regulatory matters that you can edit and use.
Provides regulatory expertise for new strategic areas and technologies required for new product development, including areas of clinical research, CMC, regulatory operations, non-clinical study requirements and early development regulatory compliance expectations
Partners with a policy to globally monitor the regulatory environment and provide an assessment of the impact of new and changing regulations on the management company’s R&D programs
Resume Skills And Keywords For Regulatory Affairs Specialist (updated For 2023)
Develop and implement competitive and effective global regulatory strategies for 2-3 products including clinical, non-clinical and CMC aspects and identify potential risks associated with proposed strategies
Leads the Regulatory sub-team, including Regional Project Managers, RA CMC and Regulatory Operations, to develop regulatory strategies for project(s) in all phases of the development life cycle.
Act as an influential and respected spokesperson with employees in
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