Global Regulatory Manager Job Description

Responsible for Regulatory Strategy Development

Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local affiliates in compliance with local regulations and to maintain compliance for products. Knowledge and expertise to guide team in building appropriate regulatory strategy is provided by this person. The person has acceptable skills with increasing independence in the area of regulatory strategy, such as understanding broad concepts within regulatory affairs and implications across the organization and globally. The skills of regulatory strategy include understanding broad concepts within regulatory affairs and implications across the organization and globally, proactive identifies regulatory issues, and offers creative solutions and strategies.

Choosing an Advanced Degree in the Regulating Affairs Sector

The scope of a regulatory professional's work varies because the field of global regulatory affairs spans a diverse set of disciplines. Career paths and daily responsibilities may differ, but regulatory professionals have the same goal in common: to facilitate the commercialization of safe and effective products and services. Some regulatory affairs professionals manage clinical studies, while others design labels for food and drug related products.

Regulatory professionals are often involved in conversations about health and public policy. The director of Northeastern's Master of Science in the Regulatory Affairs of Food and Food Industries program says that regulatory work is more than a job. The job market is growing because of the regulatory affairs discipline, which plays an important role in global health, food safety, and medical innovation.

The field of regulatory will grow at an average rate of eight percent until the year 2026, according to the Bureau of Labor Statistics. The demand for additional and specialized regulatory expertise will increase as new and developing industries become increasingly regulated. 73 percent of regulatory professionals work in regulated industries, such as pharmaceuticals, medical devices, and food science.

A small number of people choose a consultative path to get employment at legal, research, or marketing firms. The rest are employed by a mix of organizations. Regulatory professionals can choose to work in any size organization.

Employers are willing to pay more for the right skill level as demand increases. The salaries of all regulatory professions have increased an average of 3.3 percent per year since 1995. The average yearly salary for regulatory professionals was $150,422 in 2016

A Point Person to Responsible for Compliance

A regulatory requirement is a rule that a government entity imposes. Federal and state laws govern most organizations. Regulations govern how organizations manage their business and employees.

A regulatory compliance cost is the amount of money or other resources that an organization must spend to comply with the regulations. Many regulations require detailed record-keeping that requires time for employees and company resources. Any company with publicly traded stock must have a compliance officer.

Most of the companies have regulatory departments, while some banks and other large companies have hundreds of compliance staff. Smaller private companies may not have a single employee who is solely responsible for compliance. They may have a company lawyer.

The Regulatory Affairs Professionals Association

Regulatory affairs specialists are encouraged to join RAPS to take advantage of global networking opportunities while working towards the minimum three-year work experience requirement. The organization has more than 25,000 members strong and offers one or two-year memberships for individuals and teams. The Regulatory Affairs Professionals Society has provided career development resources and advocated for industry standards.

The mission of RAPS is to develop and sustain a competent global regulatory workforce that drives good regulatory practice and policy. The RAPS Online University offers continuing education opportunities for its professionals. The RAC has certified over 7,000 people in the regulatory arena.

In 2016 the earning of non-credentialed peers was 11 percent less than that of the RAC holders. The organization has annual conferences in North America and Europe and offers its 25,000 members unparalleled in-person and online networking opportunities. The RAC requires portable skill sets in critical thinking, adaptive reasoning, and collaboration.

Regardless of the job role one applies to, regulatory affairs certification can boost one's resume. To earn the RAC, one must pass a computer-based test designed for one of four geographic regions: the United States, Canada, the European Union, or Global. Veteran industry professionals are asked about their scope of practice and their specific roles and responsibilities in order to create the exams.

Each test consists of 100 multiple choice questions that must be answered in two hours. The questions are in three categories: recall, application, and analysis. The topics addressed include in vitro devices, medical devices, pharmaceuticals, and regulatory functions across the product lifecycle.