What does a regulatory affairs manager do?
A regulatory affairs manager is in charge of ensuring that all aspects of a company adhere to the rules and regulations set by regulatory agencies. Their responsibilities revolve around devising regulation compliance strategies, creating training and orientation programs to inform the staff on the policies and standards, conducting internal inspections and information drives, and keeping abreast with the latest rules and regulations. Moreover, a regulatory affairs manager is in charge of processing and submitting necessary documents to government agencies, ensuring compliance and timeliness.
Regulatory affairs manager responsibilities
Here are examples of responsibilities from real regulatory affairs manager resumes:
- Implement and achieve ISO 9001 and ISO 13485 registrations for the first time for the company.
- Manage team which monitor the clinics' daily, weekly and monthly water and equipment maintenance requirements to meet CMS regulations.
- Manage departmental and special project economics, including oversight of budgeting, expense management, and reimbursement billing.
- Coordinate, oversee and audit record-keeping requirements of DEA, OSHA, D.O.T.
- Conduct a comprehensive risk assessment of health plan with results from CMS audit as benchmark.
- Perform all AML functions on new and existing customers, including OFAC checks and CIP.
- Ensure casino floor operations are kept in standards to BSA, AML and MICS programs.
- Develop and initiate corporate ISO and validation programs.
- Develop comprehensive eCTD submission planning documents and module content templates.
- Prepare dossiers for international markets to obtain and maintain global regulatory approvals of products.
- File regulatory documents including initial investigational new drug applications, amendments, and investigator updates.
- Implement processes to ensure effective documentation control and management of international product dossiers and compliance files.
- Conduct regulatory communications with FDA, under appropriate supervision and direction, for assign products and activities.
- Communicate with multiple worldwide company affiliates for product submission and registration needs to ensure regulatory CMC compliance.
- Participate in review and analysis of relevancy coding for mass tort litigation involving a major pharmaceutical company.
Regulatory affairs manager skills and personality traits
We calculated that 11% of Regulatory Affairs Managers are proficient in Regulatory Affairs, FDA, and Medical Devices.
We break down the percentage of Regulatory Affairs Managers that have these skills listed on their resume here:
- Regulatory Affairs, 11%
Integrated regulatory affairs department responsibilities following corporate acquisition of Cadence Pharmaceuticals.
- FDA, 8%
Managed an operational team ensuring timely regulatory submissions to FDA in a department of approximately 30 regulatory professionals.
- Medical Devices, 6%
Established and implemented domestic and international import-export procedures based on FDA regulations for medical devices and components.
- Regulatory Submissions, 5%
Managed comprehensive regulatory submission processes including product license and manufacturing/processing license applications.
- Regulatory Agencies, 5%
Planned, developed and presented environmental legislative and regulatory initiatives for Congress, state legislatures, federal and state regulatory agencies.
- Global Regulatory, 5%
Developed global regulatory strategies for candidate drug products based on knowledge of U.S. and international regulatory requirements.
Common skills that a regulatory affairs manager uses to do their job include "regulatory affairs," "fda," and "medical devices." You can find details on the most important regulatory affairs manager responsibilities below.
The three companies that hire the most regulatory affairs managers are:
- Pharmaceutical Product Development
63 regulatory affairs managers jobs
- KPMG LLP43 regulatory affairs managers jobs
- Sanofi US31 regulatory affairs managers jobs
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Compare different regulatory affairs managers
Regulatory affairs manager vs. Compliance director
Compliance Directors oversee the adherence of different business units to company policies. They are considered experts on the different processes, policies, and regulatory systems that govern the business's operations, be it internal or external. They also keep themselves updated on the different external regulations and compliance procedures from governing bodies. This helps them ensure that the company is following the current guidelines. Compliance Directors have a say in the different internal company policies while overseeing the compliance to finance, human resources, and other related procedures.
While similarities exist, there are also some differences between regulatory affairs managers and compliance director. For instance, regulatory affairs manager responsibilities require skills such as "regulatory affairs," "medical devices," "regulatory submissions," and "global regulatory." Whereas a compliance director is skilled in "compliance program," "oversight," "ethics," and "risk management." This is part of what separates the two careers.
Compliance directors tend to reach similar levels of education than regulatory affairs managers. In fact, compliance directors are 2.8% less likely to graduate with a Master's Degree and 0.4% less likely to have a Doctoral Degree.Regulatory affairs manager vs. Senior officer
The duties of a senior officer depend on their line of work or industry of employment. Typically, as a senior officer, it is their duty to supervise and coordinate staff, set goals and guidelines, manage budgets and schedules, gather and analyze data, and produce progress reports, presenting them to managers or executives. They may also address issues and concerns, resolving them promptly and efficiently. Furthermore, a senior officer must lead and encourage staff to reach goals while implementing the organization's policies and regulations.
While some skills are similar in these professions, other skills aren't so similar. For example, resumes show us that regulatory affairs manager responsibilities requires skills like "regulatory affairs," "fda," "medical devices," and "regulatory submissions." But a senior officer might use other skills in their typical duties, such as, "taking care," "real estate," "professional development," and "sr."
In general, senior officers achieve similar levels of education than regulatory affairs managers. They're 2.1% more likely to obtain a Master's Degree while being 0.4% less likely to earn a Doctoral Degree.Regulatory affairs manager vs. Regulatory affairs specialist
A regulatory affairs specialist assists in securing and maintaining government approval for nutritional products, drugs, medical devices, and related supplies. They are often employed by medical, pharmaceutical, and biotechnology companies. They may also work in the government or law. Typically, they work on document preparation, file maintenance, information management, and coordination of tasks across various departments. They expanded their duties and responsibilities as a result of company acquisitions and restructuring, worldwide globalization of markets, and constantly evolving regulations.
There are many key differences between these two careers, including some of the skills required to perform responsibilities within each role. For example, a regulatory affairs manager is likely to be skilled in "global regulatory," "project management," "ind," and "health authorities," while a typical regulatory affairs specialist is skilled in "patients," "dossiers," "excellent organizational," and "safety reports."
When it comes to education, regulatory affairs specialists tend to earn similar degree levels compared to regulatory affairs managers. In fact, they're 3.9% less likely to earn a Master's Degree, and 3.5% less likely to graduate with a Doctoral Degree.Regulatory affairs manager vs. Regulatory affairs director
A regulatory affairs director's role is to spearhead the efforts to ensure that all company operations adhere to industry standards and government regulations. Their responsibilities include coordinating with different departments to gather and analyze data, evaluating compliance in various areas, preparing and processing documentation, liaising with external parties, and devising strategies to optimize company compliance. Furthermore, as a regulatory affairs director, it is essential to maintain an active communication line with the workforce, all while implementing the company's policies and regulations.
Types of regulatory affairs manager
Updated January 8, 2025
