Regulatory affairs teams often play a critical role in making sure that their company’s products and services adhere to the strict regulations and guidelines set by authorities.
With countless responsibilities and tasks to handle, it’s challenging to prioritize and stay on track. Here, we’ll cover examples of SMART goals for regulatory affairs professionals to succeed in their roles.
What is a SMART Goal?
When establishing goals for regulatory affairs, using the SMART framework is key to success. SMART stands for specific, measurable, attainable, relevant, and time-based.
Here’s a deeper look at each SMART element:
Specific
The more specific your goals are, the greater your likelihood of success. Vague goals can be arduous to reach, whereas precise ones provide a well-defined roadmap.
For example, a specific goal for improving a regulatory affairs process could be to “reduce the review time for submission approvals by 15% within the next 6 months.”
Measurable
Measurable goals are crucial because they allow for progress monitoring. Ensure that your regulatory affairs goals include criteria that can be quantified, thereby making it easier to gauge progress. Your team will be able to boost the accuracy rate in document compliance checks.
Attainable
Consider your team’s current abilities and strengths during the goal-setting process. Unrealistic expectations may result in frustration for both employees and the company.
That’s why you must pursue goals that fall within your team’s existing skill set. An achievable goal could be: “Implement a product launch strategy that can be operationalized with our current resources.”
Relevant
Focus on regulatory affairs goals that matter most to your company. Ask yourself questions such as: What aligns with our regulatory philosophy? What is our long-term plan for our regulatory team? Doing so gives you the determination to push through challenges.
Time-Based
A detailed timeline enables you to remain on track and avoid distractions. You’ll be able to prioritize tasks accordingly, allowing for proper time management. To illustrate, a time-bound goal could be to “complete the review of all drug safety documentation within the next 30 days.”
13 SMART Goals Examples for Regulatory Affairs
Let’s dive into some examples of SMART goals for regulatory affairs:
1. Reduce Product Recall Rates
“We want to reduce product recall rates by 30% in the next two quarters. To accomplish this, we will invest in more advanced quality control technologies, implement stricter testing procedures, and train employees on proper quality control measures.”
Specific: The SMART goal specifies what must be done to reduce product recall rates and by how much.
Measurable: You can track product recall rates to ensure a 50% reduction in two quarters.
Attainable: Reducing recall rates is doable with sufficient investment in quality control measures.
Relevant: This goal is crucial for regulatory affairs to keep the company’s reputation clean.
Time-based: This statement is time-bound, with an end date of two quarters.
2. Improve Quality Control Systems
“I’ll implement automated procedures to increase efficiency and reduce human error within four months. I’ll also assign additional personnel to perform quality checks and develop better testing procedures with metrics to assess effectiveness.”
Specific: You have different measures to strengthen the company’s quality control systems.
Measurable: The efficacy of the automated procedures and additional quality checks can be measured.
Attainable: Implementing automated testing procedures is achievable with the provided timeline.
Relevant: Improving quality control systems is pertinent to maintaining regulatory standards in the company.
Time-based: There is a four-month window to reach goal completion.
3. Achieving Greater Transparency
“I’ll develop an open-door policy for all employees to come forward with their questions and concerns regarding regulations by the end of 8 months. I’ll also conduct regular meetings to discuss major policy changes in business operations.”
Specific: The SMART goal specifies the policy changes necessary to achieve transparency and the implementation timeline.
Measurable: Employee feedback can provide a basis for gauging the success of policies.
Attainable: Creating an open-door policy and scheduling meetings is possible in 8 months.
Relevant: Greater transparency in business operations is fundamental to regulatory affairs.
Time-Based: Eight months are required to reach long-term success.
4. Increase Regulatory Reporting Efficiency
“To increase regulatory reporting efficiency, I’ll standardize the process for all regulatory submissions and work with IT to automate the submission and approval process where possible. I aim to decrease regulatory reporting times by 25% in four months.”
Specific: This goal describes the measures to boost efficiency and provides a quantifiable metric to be met.
Measurable: The team can track the decrease in regulatory reporting times over time.
Attainable: You and your team should be able to standardize and automate the regulatory submission process within four months.
Relevant: Increasing regulatory reporting efficiency is pertinent to meet regulatory compliance standards.
Time-based: There is a four-month deadline to achieve the SMART goal.
5. Boost Compliance Audit Scores
“I aim to increase compliance audit scores by 20% by the end of the year. I’ll conduct regular risk assessments to identify potential compliance violations, ensure proper training on regulations for all employees, and implement a corrective action plan.”
Specific: The goal is clear. The individual wants to boost compliance audit scores.
Measurable: Compliance audit scores provide a baseline measure to gauge progress toward the 20% increase.
Attainable: Following the three listed action items will help you reach success.
Relevant: Boosting compliance audit scores is essential to meet regulatory standards and avoid penalties.
Time-based: Goal attainment is expected after one whole year.
6. Enhance Regulatory Awareness
“I plan to increase overall regulatory knowledge within the company by 40% over two quarters. To do so, I will strive to conduct regular training sessions and provide access to regulatory resources for all employees.”
Specific: Your company wants to enhance regulatory awareness through employee training and resources.
Measurable: The knowledge of employees can be evaluated by conducting pre- and post-training assessments.
Attainable: A 40% boost in knowledge is absolutely feasible, given the time frame.
Relevant: Enhancing regulatory awareness helps you identify and avoid potential risks of non-compliance.
Time-based: You want to accomplish this goal by the end of two quarters.
7. Advance Risk Management Strategies
“I will create a comprehensive risk management plan incorporating key strategies and integrated processes across our company. I want this strategy to be in place within the next 12 months.”
Specific: The goal explains what should be done and when it’s expected to be completed.
Measurable: Measure the effectiveness of the risk management plan by assessing its impact on the company’s operations.
Attainable: This SMART statement is possible due to the timeline and available resources.
Relevant: Risk management is important to a company’s operations as it helps identify and mitigate risks.
Time-based: There is a 12-month end date to meet this particular goal.
8. Develop Strategic Partnerships
“To improve relationships with key stakeholders in regulatory affairs, I will develop strategic partnerships for 9 months. This involves researching potential partners, creating agreements for collaboration, and strengthening existing relationships.”
Specific: The aim is to research, create agreements for collaboration and strengthen relationships.
Measurable: You should assess the number of strategic partnerships developed.
Attainable: Provided you’re actively working on growing partnerships, this is a feasible goal.
Relevant: This directly contributes to developing strategic partnerships that benefit your regulatory affairs activity.
Time-based: You have 9 whole months to meet goal completion.
9. Strengthen Regulatory Training Programs
“I’ll work with the necessary departments to design and launch a comprehensive regulatory training program within 6 months. The program will ensure staff members understand regulatory requirements and are updated on regulation changes that may affect their work.”
Specific: You plan to design and launch a comprehensive regulatory training program.
Measurable: You could regularly track the completion rate of staff members in the program.
Attainable: This is reachable because the person is taking action to ensure compliance with regulatory requirements.
Relevant: The goal is appropriate because it ensures staff members are aware of necessary regulations and up to date on changes.
Time-based: The statement is time-bound because it has an end date of 6 months.
10. Improve Documentation
“I will make sure that all documents related to regulatory affairs are edited for errors and updated with accurate information within three months. This will ensure all documents are consistent and up to date to meet regulatory requirements.”
Specific: This requires the person to ensure all regulatory affairs documents are edited and updated.
Measurable: Benchmark progress by tracking the time it takes to finish editing and updating each document.
Attainable: This goal is achievable with enough time to edit and update documents.
Relevant: Improving documentation is essential to meet current regulatory requirements.
Time-based: You have three months to meet your desired SMART goal.
11. Support Open Communication
“I’ll create an open line of communication with government agencies by the end of 7 months. I want to assure that all regulations and procedures are understood and respected so that our company can comply with all laws.”
Specific: The goal is clear: create an open line of communication with government agencies.
Measurable: Make sure you count the number of agencies contacted.
Attainable: Supporting an open line of communication is within the realm of possibility for your business.
Relevant: Communicating with government agencies is vital to ensure compliance with all laws.
Time-based: You have a 7-month window to reach this goal statement.
12. Implement Automated Procedures
“I want to implement automated procedures for regulatory compliance processes over the one year ahead. I hope to make it easier and more efficient for the regulatory team to complete tasks promptly without sacrificing accuracy or quality.”
Specific: The goal is easy to understand, stating the objective and how it will be accomplished.
Measurable: By implementing automated procedures, the regulatory team can track the time to complete processes.
Attainable: This goal can be reached by working with IT professionals to develop automated procedures.
Relevant: This is pertinent to regulatory compliance because it ensures processes are completed accurately and efficiently.
Time-based: You have one year to reach goal achievement.
13. Harvest Competitive Intelligence
“I plan to collect competitive intelligence data and monitor new products, services, and technologies offered by other organizations in our industry. I’ll use the intelligence gathered to create strategies to improve our products and service offerings for 12 months.”
Specific: The goal mentions the activities you need to perform (collecting and monitoring intelligence data) and the time frame for these activities.
Measurable: You can track your collected intelligence data and determine how the strategies have improved your products.
Attainable: It’s possible to monitor other organizations’ offerings and use the data collected in developing methods.
Relevant: Competitive intelligence helps you improve your organization’s products, which benefits regulatory affairs.
Time-based: You should complete this statement after 12 months.
Final Thoughts
Creating SMART goals allows regulatory affairs professionals to focus their efforts and stay energized. They can streamline their work and ensure the company’s products meet the highest standards.
Through careful planning and regular monitoring, regulatory affairs professionals can take their skills and performance to the next level and become true company assets.
