Regulatory Affairs Managers

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

Enterprising occupations frequently involve starting up and carrying out projects. These occupations can involve leading people and making many decisions. Sometimes they require risk taking and often deal with business.

Enterprising

Second Interest High-Point

Conventional occupations frequently involve following set procedures and routines. These occupations can include working with data and details more than with ideas. Usually there is a clear line of authority to follow.

Conventional

First Interest High-Point

Social occupations frequently involve working with, communicating with, and teaching people. These occupations often involve helping or providing service to others.

Social

Investigative occupations frequently involve working with ideas, and require an extensive amount of thinking. These occupations can involve searching for facts and figuring out problems mentally.

Investigative

Realistic occupations frequently involve work activities that include practical, hands-on problems and solutions. They often deal with plants, animals, and real-world materials like wood, tools, and machinery. Many of the occupations require working outside, and do not involve a lot of paperwork or working closely with others.

Realistic

Artistic occupations frequently involve working with forms, designs and patterns. They often require self-expression and the work can be done without following a clear set of rules.

Artistic

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Job Zone Four: Considerable Preparation Needed

Provide responses to regulatory agencies regarding product information or issues.

Direct the preparation and submission of regulatory agency applications, reports, or correspondence.

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

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

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

Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.

Maintain current knowledge of relevant regulations, including proposed and final rules.

Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.

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

Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.

Direct documentation efforts to ensure compliance with domestic and international regulations and standards.

Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.

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

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

Train staff in regulatory policies or procedures.

Develop and maintain standard operating procedures or local working practices.

Participate in the development or implementation of clinical trial protocols.

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

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

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

Coordinate internal discoveries and depositions with legal department staff.

Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.

Establish regulatory priorities or budgets and allocate resources and workloads.

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

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

Monitor regulatory affairs trends related to environmental issues.

Evaluate regulatory affairs aspects that are specifically green, such as the use of toxic substances in packaging, carbon footprinting issues, or green policy implementation.

Computer laser printers

Desktop computers

Laptop computers

Laser facsimile machines

Multi-line telephone systems

Personal computers

Photocopying equipment

Adlib Express

Adobe Systems Adobe Acrobat

Analyse-it

Aris Global Register

Axway eSubmissions

Database software

Datafarm a-Pulse

Datafarm eCTDGatekeeper

Datafarm eCTDViewer

Datafarm S-Cubed

Dialog DialogLink

Document publishing software

DoubleBridge ROSETTA Phoenix eCTD Viewer

DoubleBridge ROSETTA Pyramid

DoubleBridge ROSETTA Sceptre

DoubleBridge ROSETTA Scribe

Electronic common technical document eCTD software

Electronic common technical document eCTD validating software

Electronic common technical document eCTD viewing software

Electronic document management system EDMS

Enterprise content management ECM software

Extedo DOCvalidator

Extedo eCTDmanager Suite

Extedo PLmanager

GlobalSubmit REVIEW

GlobalSubmit VALIDATE

Image Solutions eCTDXpress

Image Solutions ISIPublisher

Integrated development environment IDE software

Lorenz DocuBridge

Lorenz eValidator

Lorenz labelBridge

MasterControl software

MediRegs E-dition Compliance Monitor

MediRegs Pharmaceutical Regulation Suite

MediRegs Regulation and Reimbursement Suite

MediRegs Risk Assessment Manager

MedXView eCTDauditor

Microsoft Access

Microsoft Excel

Microsoft Office

Microsoft Outlook

Microsoft PowerPoint

Microsoft Project

Microsoft SharePoint

Microsoft Visio

Microsoft Windows

Microsoft Word

Octagon StartingPoint

Octagon ViewPoint eCTD Complete

Pilgrim Regulatory Submission

Risk management software

Samarind RMS

SAP EHS Management

Spreadsheet software

Statistical analysis software

Structured query language SQL

Take Solutions PharmaReady Document Management System

Thomson Reuters Liquent CoreDossier Submission Accelerator for eCTD

Thomson Reuters Liquent InSight Suite

Total quality management TQM software

Virtify eCTD

Web browser software

Word processing software

XML authoring software

Try to work in the summers as an intern or Trainee. Apply to companies where you would like to pursue your career. In the best case, they might hire you after you complete your university degree. Or, you might find out that this sort of job is not what you would like to do in future.

Working in the oil and petroleum sector can be hectic. A typical day starts with video conferences with colleagues in overseas offices. There might be a time difference, meaning you might have to come to office early or leave late. Afternoon meetings, presentations to your team of the weekly and monthly progresses.

Maria Gilani

MA International Affairs

Milestones

Education

Career

Career Roadmap

My work combines:

My work combines:

Politics

Writing

Helping People

Day to Day

Advice for Getting Started

Recommended Education

Hurdles

The Noise I Shed

From Family:

Maria Gilani

MA International Affairs

Milestones

Education

Career

Career Roadmap

My work combines:

My work combines:

Politics

Writing

Helping People

Day to Day

Advice for Getting Started

Recommended Education

My career is not related to what I studied. I'd recommend this path instead:

Hurdles

The Noise I Shed

From Family:

Related Leaders