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Manager, Regulatory Affairs
Ref No.: 20-07876
Location: Madison, New Jersey
Sunrise System Inc. is currently looking for Manager, Regulatory Affairs in Madison, NJ with one of our top client.


Job Title: Regulatory Affairs Manager
Job Id: 20-07876
Location: Remote
Duration: 14 months
Position Type: Hourly contract Position (W2 only)
 
Summary:
  • Under general direction, responsible for successfully filing original Abbreviated New Drug Application submissions and for managing post approval changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. Determines nature and scope of information to be generated to successfully file required regulatory documents. Keeps Company informed of significant regulatory issues that affect assigned products/projects.
 
Essential Job Functions:
  • This is not intended as a comprehensive list; it is intended to provide a representative summary of the major duties and responsibilities. Incumbent(s) may not be required to perform all duties listed, and may be required to perform additional, position-specific tasks.
  • Carries out managerial responsibilities in accordance with the organization’s policies, procedures, and state, federal and local laws.
  • Directs, coordinates and prioritizes the daily activities of the assigned staff.
  • Reviews and approves regulatory submissions (i.e. ANDAs, amendments, supplements, etc.) to the Food and Drug Administration (FDA) to ensure compliance with applicable regulations and guidance’s.
  • Interacts with various departments as needed on regulatory issues and/or strategy. Effectively guides, communicates and implements determined strategy with the appropriate departments and/or employees.
  • Review and approve change notices, specifications, batch records, standard test methods, etc.
  • Implements policies to assure on-going compliance of Regulatory Affairs activities.
  • Assesses impact of new regulations and suggests appropriate changes to business processes/policies as necessary.
  • Interacts with the FDA to facilitate approval of the regulatory submissions.
  • Maintains awareness of all regulatory activities on assigned projects. Works to minimize regulatory issues and helps prevent unnecessary regulatory delays.
  • Interacts with outside consultants and or contractors as needed.
  • Troubleshoots data and resolves problems with technical issues such as test methods and instrumentation.
  • Provides support, direction and coaching to subordinate employees in the areas of hiring, training, disciplinary action, problem resolution, planning, and work assignment delegation.
  • Conducts performance evaluations for direct reports.
  • Meets project deadlines and established performance standards.
  • Complies with all Company policies and procedures, including safety rules and regulations, and guides subordinates in this area.
  • Performs related duties as assigned.
 
Required Knowledge and Skills:
Knowledge of:
  • FDA, SOP and cGMP standards, guidelines and regulatory compliance regulations.
  • Pertinent Federal and State laws related to pharmaceutical regulatory affairs.
  • Supervision and training practices and methods.
  • Business, scientific and personal computer software applications.
  • Business English usage such as, spelling, grammar and punctuation.
  • Recruiting, interviewing and selecting of applicants in accordance with established employment practices and methods.
  • Company policies, practices and procedures, including safety rules and regulations.
  • Principles and practices of budget preparation and administration.
 
Skill in:
  • Creating, planning and implementing group goals, objectives and practices for effective, efficient and cost effective management of allocated resources.
  • Responding to general and/or sensitive inquiries from management, employees and regulatory agencies.
  • Preparing, presenting and administering budgets and financial reports.
  • Communicating clearly and concisely, both orally and in writing.
  • Managing multiple projects, duties and assignments.
  • Interpreting and applying Federal, state and local policies, procedures, laws and regulations.
  • Directing, coordinating, delegating assignments and reviewing the work of assigned department personnel.
  • Establishing and maintaining cooperative working relationships with others.
  • Ensuring compliance with all Company policies and procedures, including safety rules and regulations.
 
Physical Requirements and Working Conditions: Incumbents in this class are subject to extended periods of sitting, standing and walking, vision to monitor, moderate noise levels and frequent business travel. Work is performed in an office environment.
 
Contact
Rahul
Direct: (732) 837 0410|Email:rahul.r@sunrisesys.com
Or
Michael Peng
Direct: (732) 272 0265 | Michael@sunrisesys.com