~ Lift as you climb
Regulatory Affairs Managers
Plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
Job Info
Job Category:
Management
Sub Category:
Top Executives
Job Type:
Full-time
Job Code: 11-9199.01
Job Salary Range:
$ 130000 - 140000 Per Year
Job Shift:
Morning
Duration:
Full Time
Posted:
2024-11-11
Gender:
Does not matter
Age:
35 Years - 35 Years
Minimum Education:
College
Degree Title:
Bachelor's Degree
Minimum Experience:
5 Year
Career Level:
Executive (Department Head, SVP, VP etc)
Work Permit:
United States
Required Travel:
50%
Job Status:
Interviewing
No of Jobs:
1
Start Publishing:
2024-11-11
Stop Publishing:
2025-11-11
Work Activities
Tasks
Technology Skills
-
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.
-
Communicating with People Outside the 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.
-
Communicating with Supervisors, Peers, or Subordinates — Providing information to supervisors, co-workers, and subordinates by telephone, in written form, e-mail, or in person.
-
Interpreting the Meaning of Information for Others — Translating or explaining what information means and how it can be used.
-
Getting Information — Observing, receiving, and otherwise obtaining information from all relevant sources.
-
Develop regulatory strategies and implementation plans for the preparation and submission of new products.
-
Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
-
Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
-
Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
-
Provide responses to regulatory agencies regarding product information or issues.
-
Compliance software — Aris Global Register; MediRegs E-dition Compliance Monitor; SAP EHS Management; Thomson Reuters Liquent InSight Suite
-
Data base user interface and query software — Database software; Microsoft Access ; Structured query language SQL
-
Document management software — Adlib Express; Adobe Acrobat ; Axway eSubmissions; Virtify eCTD
-
Presentation software — Microsoft PowerPoint
-
Risk management data and analysis software — MasterControl software; Risk management software
Facebook Comments
Apply Now
MAKE AN ENQUIRY
Speak to us today
We appreciate your support and look forward to connecting with you soon.