Regulatory Affairs Managers

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SNAPSHOT
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Leadership
HIGH
Critical decision making
HIGH
Level of responsibilities
LOW
Job challenge and pressure to meet deadlines
HIGH
Dealing and handling conflict
LOW
Competition for this position
MED
Communication with others
HIGH
Work closely with team members, clients etc.
HIGH
Comfort of the work setting
HIGH
Exposure to extreme environmental conditions
LOW
Exposure to job hazards
LOW
Physical demands
LOW
Daily tasks

Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates on electronic publishing of submissions.

Establish procedures or systems for publishing document submissions in hardcopy or electronic formats.

Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.

Participate in the development or implementation of clinical trial protocols.

Contribute to the development or implementation of business unit strategic and operating plans.

Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.

Manage activities such as audits, regulatory agency inspections, or product recalls.

Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.

Develop regulatory strategies and implementation plans for the preparation and submission of new products.

Develop and maintain standard operating procedures or local working practices.

Monitor regulatory affairs activities to ensure their alignment with corporate sustainability or green initiatives.

MAIN ACTIVITIES
Getting Information Observing, receiving, and otherwise obtaining information from all relevant sources.
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.
Updating and Using Relevant Knowledge Keeping up-to-date technically and applying new knowledge to your job.
Making Decisions and Solving Problems Analyzing information and evaluating results to choose the best solution and solve problems.
Communicating with Supervisors, Peers, or Subordinates Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
Documenting/Recording Information Entering, transcribing, recording, storing, or maintaining information in written or electronic/magnetic form.
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.
Interpreting the Meaning of Information for Others Translating or explaining what information means and how it can be used.
AREAS OF KNOWLEDGE
English Language Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar.
Law and Government Knowledge of laws, legal codes, court procedures, precedents, government regulations, executive orders, agency rules, and the democratic political process.
Administration and Management Knowledge of business and management principles involved in strategic planning, resource allocation, human resources modeling, leadership technique, production methods, and coordination of people and resources.
Biology Knowledge of plant and animal organisms, their tissues, cells, functions, interdependencies, and interactions with each other and the environment.
Medicine and Dentistry Knowledge of the information and techniques needed to diagnose and treat human injuries, diseases, and deformities. This includes symptoms, treatment alternatives, drug properties and interactions, and preventive health-care measures.
Education and Training Knowledge of principles and methods for curriculum and training design, teaching and instruction for individuals and groups, and the measurement of training effects.
Computers and Electronics Knowledge of circuit boards, processors, chips, electronic equipment, and computer hardware and software, including applications and programming.
Clerical Knowledge of administrative and clerical procedures and systems such as word processing, managing files and records, stenography and transcription, designing forms, and other office procedures and terminology.
TOP SKILLS
Writing Communicating effectively in writing as appropriate for the needs of the audience.
Speaking Talking to others to convey information effectively.
Reading Comprehension Understanding written sentences and paragraphs in work related documents.
Coordination Adjusting actions in relation to others' actions.
Monitoring Monitoring/Assessing performance of yourself, other individuals, or organizations to make improvements or take corrective action.
Critical Thinking Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Active Listening Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Judgment and Decision Making Considering the relative costs and benefits of potential actions to choose the most appropriate one.