|
|
|
|
ID 298 Manager Regulatory Affairs, Proprietary Job
|
| Employer Name: |
SpiderID: 2293922 |
| Location: Utah, Utah |
Date Posted: 6/18/2008 |
| Wage: |
Category: Management |
| Job Code: |
|
Job Description:
Job Description:
Under general direction, functions as primary Chemistry, Manufacturing, and Controls (CMC) regulatory contact with regulatory authorities for assigned products and projects. Manages preparation of CMC sections of regulatory submissions.
• Determines nature, scope and format of CMC information to be generated in order to successfully: file and maintain INDs/CTAs; file regulatory dossiers; respond to health authority inquiries; and obtain and maintain market approval for development and approved products.
• Functions as primary contact for CMC issues with regulatory authorities for assigned products and projects. Prepares and issues Regulatory Agency Telephone Contact Reports and Meeting Minutes.
• Manages response team for regulatory agency CMC inquiries.
• Administers preparation of briefing and presentation materials for Regulatory Agency meetings.
• Represents Regulatory Affairs CMC on project teams for assigned products/projects.
• Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and applicable state federal and local laws.
• Ensures compliance with all Company policies and procedures, including safety rules, federal, state and local laws regulations.
• Ensures project deadlines and performance standards are established and met.
Job Requirements:
Qualifications:
Three (3) to five (5) years regulatory experience; or equivalent combination of education and experience.
Knowledge of:
• Regulatory environment, regulatory submission and/or pharmaceutical healthcare environment.
• Business and personal computer hardware and software applications.
• Business English usage, spelling, grammar and punctuation.
• Supervision and training practices and methods.
• Current Company policies, practices and procedures, including safety rules and regulations.
Skill in:
• Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
• Responding to inquiries from management, employees and regulatory agencies.
• Communicating clearly and concisely, both orally and in writing.
• Analyzing problems, identifying alternative solutions, and implementing recommendations for resolution.
• Managing multiple projects, duties and assignments.
• Establishing and maintaining cooperative working relationships with others.
• Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
Education:
Bachelor’s Degree in scientific field from an accredited college or
university. Master’s Degree preferred.
Education requirements BA/BS
Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required: 3
Education Required: Bachelors
Overnight Travel:
Vacation Time:
Contact Information:
| Contact Name: Camley Hitti |
Company Type: |
| Company: |
|
|
|
| City: Clinton |
|
| State: New York |
|
| Zip: 13323 |
|
Web Site: http://www.grnutica.com
|
|
|
|
|
|
|