Regulatory Affairs Managers :: Job Description

ExistingUsers

User Name:

Password:

Forgot your password?
Click here

NewUsers

FeaturedResources

Regulatory Affairs Managers

Careers / Regulatory Affairs Managers

Summary Description


	Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.

Sample Job Titles

1.	Clinical Trials Systems Administrator

2.	Global Regulatory Affairs Manager

3.	Global Regulatory Affairs Vice President

4.	Regulatory Administrator

5.	Regulatory Affairs Director

6.	Regulatory Affairs Manager

7.	Regulatory Affairs Portfolio Leader

8.	Regulatory Consultant

9.	Regulatory Leader

10.	Regulatory Process Manager

11.	Regulatory Product Manager

Job Tasks

	Direct the preparation and submission of regulatory agency applications, reports, or correspondence. Manage control system activities in organizations.

	Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards. Review documents or materials for compliance with policies or regulations.

	Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. Advise others on legal or regulatory compliance matters.

	Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced. Implement organizational process or policy changes. Develop organizational policies or programs. Develop operating strategies, plans, or procedures.

	Communicate regulatory information to multiple departments and ensure that information is interpreted correctly. Communicate organizational policies and procedures.

	Manage activities such as audits, regulatory agency inspections, or product recalls. Manage control system activities in organizations.

	Develop regulatory strategies and implementation plans for the preparation and submission of new products. Develop operating strategies, plans, or procedures.

	Provide responses to regulatory agencies regarding product information or issues. Coordinate with external parties to exchange information.

	Maintain current knowledge of relevant regulations, including proposed and final rules. Maintain knowledge of current developments in area of expertise.

	Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary. Prepare reports related to compliance matters. Maintain regulatory or compliance documentation.

	Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met. Examine marketing materials to ensure compliance with policies or regulations.

	Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. Monitor organizational procedures to ensure proper functioning. Implement organizational process or policy changes.

	Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products. Represent the organization in external relations.

	Oversee documentation efforts to ensure compliance with domestic and international regulations and standards. Manage control system activities in organizations.

	Participate in the development or implementation of clinical trial protocols. Develop organizational methods or procedures.

	Develop and maintain standard operating procedures or local working practices. Develop operating strategies, plans, or procedures.

	Establish regulatory priorities or budgets and allocate resources and workloads. Develop organizational goals or objectives. Prepare operational budgets. Prepare staff schedules or work assignments.

	Train staff in regulatory policies or procedures. Conduct employee training programs.

	Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes. Monitor external affairs or events affecting business operations.

	Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats. Develop operating strategies, plans, or procedures.

	Contribute to the development or implementation of business unit strategic and operating plans. Implement organizational process or policy changes. Develop operating strategies, plans, or procedures.

	Coordinate internal discoveries and depositions with legal department staff. Confer with organizational members to accomplish work activities.

	Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions. Evaluate potential of products, technologies, or resources. Coordinate operational activities with external stakeholders.

Work Activities

Importance	Work Activity

Evaluating Information to Determine Compliance with Standards — Using relevant information and individual judgment to determine whether events or processes comply with laws, regulations, or standards.

Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.

Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.

Communicating with Persons Outside Organization — Communicating with people outside the organization, representing the organization to customers, the public, government, and other external sources. This information can be exchanged in person, in writing, or by telephone or e-mail.

Updating and Using Relevant Knowledge — Keeping up-to-date technically and applying new knowledge to your job.

Organizing, Planning, and Prioritizing Work — Developing specific goals and plans to prioritize, organize, and accomplish your work.

Establishing and Maintaining Interpersonal Relationships — Developing constructive and cooperative working relationships with others, and maintaining them over time.

Making Decisions and Solving Problems — Analyzing information and evaluating results to choose the best solution and solve problems.

Documenting/Recording Information — Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.

Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.

Interacting With Computers — Using computers and computer systems (including hardware and software) to program, write software, set up functions, enter data, or process information.

Developing Objectives and Strategies — Establishing long-range objectives and specifying the strategies and actions to achieve them.

Analyzing Data or Information — Identifying the underlying principles, reasons, or facts of information by breaking down information or data into separate parts.

Resolving Conflicts and Negotiating with Others — Handling complaints, settling disputes, and resolving grievances and conflicts, or otherwise negotiating with others.

Identifying Objects, Actions, and Events — Identifying information by categorizing, estimating, recognizing differences or similarities, and detecting changes in circumstances or events.

Processing Information — Compiling, coding, categorizing, calculating, tabulating, auditing, or verifying information or data.

Scheduling Work and Activities — Scheduling events, programs, and activities, as well as the work of others.

Developing and Building Teams — Encouraging and building mutual trust, respect, and cooperation among team members.

Provide Consultation and Advice to Others — Providing guidance and expert advice to management or other groups on technical, systems-, or process-related topics.

Coordinating the Work and Activities of Others — Getting members of a group to work together to accomplish tasks.

Coaching and Developing Others — Identifying the developmental needs of others and coaching, mentoring, or otherwise helping others to improve their knowledge or skills.

Guiding, Directing, and Motivating Subordinates — Providing guidance and direction to subordinates, including setting performance standards and monitoring performance.

Training and Teaching Others — Identifying the educational needs of others, developing formal educational or training programs or classes, and teaching or instructing others.

Thinking Creatively — Developing, designing, or creating new applications, ideas, relationships, systems, or products, including artistic contributions.

Performing Administrative Activities — Performing day-to-day administrative tasks such as maintaining information files and processing paperwork.

Monitor Processes, Materials, or Surroundings — Monitoring and reviewing information from materials, events, or the environment, to detect or assess problems.

Staffing Organizational Units — Recruiting, interviewing, selecting, hiring, and promoting employees in an organization.

Selling or Influencing Others — Convincing others to buy merchandise/goods or to otherwise change their minds or actions.

Judging the Qualities of Things, Services, or People — Assessing the value, importance, or quality of things or people.

Estimating the Quantifiable Characteristics of Products, Events, or Information — Estimating sizes, distances, and quantities; or determining time, costs, resources, or materials needed to perform a work activity.

Monitoring and Controlling Resources — Monitoring and controlling resources and overseeing the spending of money.

Inspecting Equipment, Structures, or Material — Inspecting equipment, structures, or materials to identify the cause of errors or other problems or defects.

Assisting and Caring for Others — Providing personal assistance, medical attention, emotional support, or other personal care to others such as coworkers, customers, or patients.

<< Previous Page

Next Page >>

Interesting Fact

7.5% of Americans are self-employed as entrepreneurs, freelancers, contractors, or owners of small businesses.

Did you know...

The MyPlan.com Majors Database provides detailed profiles on more than 1,100 different majors and degree programs available in the U.S.