For The Candidates

Ra Mgr - Regulatory Affairs Manager-Pharm
NC
Type: Full-Time
Category: Regulatory Affairs
Job ID: 798
Opportunity Description:

(919) Area Code              Raleigh/Durham           

Regulatory Manager

Duties/Responsibilities
s
• Coordinate the planning, scheduling, preparation, reviewing, and assembling of regulatory
  projects and submissions, including developing the content and format of regulatory
  submissions.

• Provide support to clinical, quality, and other scientific development disciplines to assure that
  documentation conforms to applicable regulations and guidelines.

• Collect, review, organize, assemble and check data reports and summaries, to assure full
   compliance with the FDA regulations and past agency actions.

• Maintain working knowledge of regulatory submissions, understanding of product
  chemistries, manufacturing processes and analytical packages, and their regulatory
  implication.  Provide advice and suggest strategies as required to facilitate regulatory
  actions.  Implement and manage approval activities to assure timely market entry.  Provide
  timely review of technical data, labeling, promotional material, and any other collareral
  documents that are subject to regulatory control.

• Coordinate post approval activities (annual reports, adverse event reporting, registrations,
   field alerts, SUPAC, etc.).

• Perform regulatory research including regulations, guidance’s, SBAs, FR, PDR, etc. and
  marketed product labels via the internet or other databases.  Provide timely information to
  regulatory bodies that may be required for adverse events, field actions, recalls or other such
  activities.  Maintain required records.  Supervise, as needed any recall activities.

• Establish and maintain policies and procedures to ensure compliance with government
  regulations and international Good Manufacturing Practice (GMP).

• Attend FDA related meetings as necessary.

• Work closely with R&D Project Manager on a project basis to assure transfer of information
  in a timely manner.

• Work with Process Development, Manufacturing, and Quality Assurance to prepare for pre
  and post approval inspections and final product launch.


Requirements
s
 • Bachelor’s degree in a scientific discipline with at least 8 years experience in the
   pharmaceutical industry, including at least 6 years in pharmaceutical regulatory affairs.  

• Masters Degree, Ph.D., or Pharm D. with at least 6 years experience in the pharmaceutical
  industry, including at least 4 years in pharmaceutical regulatory affairs.  

• Regulatory Affairs Certification Exam (RAC) certification preferred

 
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