What does a regulatory affairs director do?
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.
Regulatory affairs director responsibilities
Here are examples of responsibilities from real regulatory affairs director resumes:
- Implement ISO 9001complaint quality system and manage surveillance audits.
- Assess state Medicaid manage care contract and vendor contract requirements to create compliance audit plans.
- Manage customer complaints, including MDR submissions, maintenance of complaint database, and correspondence with the customer.
- Provide subject matter expertise involving applicable FDA regulations, EU directives, ISO and ASTM standards, and applicable ICH guidelines.
- Secure timely approvals for company products (IDE, PMA, Import/Export, ISO).
- Prep stability reports for international markets in accordance with FDA and ICH guidelines.
- Review and evaluation of supporting documentation for accuracy and conformance with the applicable ICH and FDA regulations and guidance's.
- Provide key CMC regulatory advice and strategy for product development projects.
- Provide metadata for eCTD submissions.
- Review AML, suspicious activities and fraud cases.
- Develop corrective action processes and procedures for CMS audit deficiencies.
- Provide training to staff on new Medicare regulations and initiatives.
- Design alert parameters on AML monitoring system (Actimize).
- Serve as a primary liaison and author for post-market supplement submissions to NDA and ANDA.
- Conduct thorough due diligence research using systems and information resources to determine whether BSA risks exist.
Regulatory affairs director skills and personality traits
We calculated that 13% of Regulatory Affairs Directors are proficient in Regulatory Affairs, FDA, and Regulatory Strategy.
We break down the percentage of Regulatory Affairs Directors that have these skills listed on their resume here:
- Regulatory Affairs, 13%
Selected by senior leadership to participate in the Abbott Regulatory Council key business initiative program to improve Regulatory Affairs across Abbott.
- FDA, 8%
Maintained regular contact and consulted as required with counsel knowledgeable in FDA regulatory matters.
- Regulatory Strategy, 7%
Developed Regulatory strategy and provided guidance for expanding existing and new product(s) into international markets.
- Global Regulatory, 7%
Drug facility registrations and listings for global regulatory health agencies and state licensing, including animal feed transportation taxes.
- Regulatory Agencies, 7%
Prepared and filed annual and quarterly financial statements with regulatory agencies in three states and the Federal Energy Regulatory Commission.
- Regulatory Submissions, 4%
Support the preparation of scientifically sound Regulatory submissions in line with requirements and company policies and procedures.
"regulatory affairs," "fda," and "regulatory strategy" are among the most common skills that regulatory affairs directors use at work. You can find even more regulatory affairs director responsibilities below, including:
The three companies that hire the most regulatory affairs directors are:
- Cardinal Health49 regulatory affairs directors jobs
- Glaxosmithkline28 regulatory affairs directors jobs
- Merck21 regulatory affairs directors jobs
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Compare different regulatory affairs directors
Regulatory affairs director vs. Compliance manager
Compliance managers are professionals who maintain the ethical and legal integrity of an organization. They establish and oversee control systems to deal with and prevent violations against internal policies and legal guidelines. It is their responsibility to assess the efficiency of controls and improve their continuity. They are professionals with exceptional analytical skills as they design control systems, execute regular audits, and enforce organizational policies. The skills necessary for this job include strong communication skills and knowledge of industry regulations and procedures.
These skill sets are where the common ground ends though. The responsibilities of a regulatory affairs director are more likely to require skills like "regulatory affairs," "regulatory strategy," "global regulatory," and "regulatory submissions." On the other hand, a job as a compliance manager requires skills like "oversight," "ethics," "compliance program," and "risk assessments." As you can see, what employees do in each career varies considerably.
Compliance managers earn the highest salaries when working in the finance industry, with an average yearly salary of $102,101. On the other hand, regulatory affairs directors are paid more in the pharmaceutical industry with an average salary of $111,416.On average, compliance managers reach similar levels of education than regulatory affairs directors. Compliance managers are 0.8% more likely to earn a Master's Degree and 8.8% less likely to graduate with a Doctoral Degree.Regulatory affairs director 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.
Each career also uses different skills, according to real regulatory affairs director resumes. While regulatory affairs director responsibilities can utilize skills like "regulatory affairs," "fda," "regulatory strategy," and "global regulatory," senior officers use skills like "taking care," "real estate," "professional development," and "sr."
On average, senior officers earn a lower salary than regulatory affairs directors. Some industries support higher salaries in each profession. Interestingly enough, senior officers earn the most pay in the finance industry with an average salary of $92,279. Whereas regulatory affairs directors have higher pay in the pharmaceutical industry, with an average salary of $111,416.senior officers earn higher levels of education than regulatory affairs directors in general. They're 7.2% more likely to graduate with a Master's Degree and 8.8% less likely to earn a Doctoral Degree.Regulatory affairs director 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.
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 director is likely to be skilled in "regulatory affairs," "regulatory strategy," "global regulatory," and "regulatory submissions," while a typical compliance director is skilled in "compliance program," "oversight," "ethics," and "compliance issues."
Compliance directors earn the highest salary when working in the finance industry, where they receive an average salary of $115,645. Comparatively, regulatory affairs directors have the highest earning potential in the pharmaceutical industry, with an average salary of $111,416.compliance directors typically earn similar educational levels compared to regulatory affairs directors. Specifically, they're 2.3% more likely to graduate with a Master's Degree, and 4.9% more likely to earn a Doctoral Degree.Regulatory affairs director vs. Director
Directors work in show business, whether in a film, a television show, or a theatre production. They are responsible for bringing the material to life. They work with the writers to get a clear vision of how the production should look. They lead the production team in planning for the production, identifying filming or rehearsing schedules, casting for roles, and other aspects that need to be decided upon. Directors provide direction to the actors to ensure that the actors understand their role and will be able to effectively convey emotions to the audience. They also manage all other crew members and communicate their expectations clearly so that everyone on the set is working towards one vision.
Types of regulatory affairs director
Updated January 8, 2025
