Associate Director of Regulatory Afffairs - Monroe, North Carolina United States - 18809



JOB DESCRIPTION

Job #: 18809
Title: Associate Director of Regulatory Afffairs
Job Location: Monroe, North Carolina - United States
Employment Type:
Salary: $95,000.00 - $120,000.00 - US Dollars - Yearly
Employer Will Recruit From: Nationwide
Relocation Paid?: Yes

WHY IS THIS A GREAT OPPORTUNITY?


We are looking for an Associate Director of Regulatory Affairs to lead and drive the regulatory affairs activities and initiatives in support of strategy, development, and submission. This position is a key member of project teams and is responsible for implementation of regulatory strategies across multiple programs. This position is expected to bring a combined knowledge of scientific, regulatory, and business issues to all relevant stakeholders to ensure products meet regulatory standards and required legislation. 

JOB DESCRIPTION

Key Responsibilities:  

  • Manage all US Regulatory Affairs matters for the site facility and supervise site RA personnel. Support import/export activities, change control, site transfer matters, original ANDA and supplement filing strategy, and all other regulatory functions at the site.
  • Regional review of development strategy
  • Responsible for submission content
  • ANDA: Manage and review assigned original ANDAs. Liaise with counterpart in HO
  • Serve as the Regulatory Affairs representative on project teams and assure the progress of projects by providing direction, solutions and feedback to the teams
  • Maintain awareness and communicate with team members regarding changing regulatory requirements
  • Have overall responsibility for ensuring that all state and federal regulatory requirements are addressed 
  • Provide current status of regulatory guidances, familiar with latest regulations, awareness of competitive performance
  • Provide support to Senior Director, RA, US, to form networks with company senior management, updating them regularly on regulatory developments regarding site products
  • Ensure that the interfaces between Regulatory and other departments are managed optimally
  • Work closely with India RA team to ensure one voice to other stakeholders 
  • International and domestic travel

QUALIFICATIONS

Education:

  •  M.S., PharmD, is preferred. Equivalent workplace experience will be considered  

 
Experience: 

  •  7-9 years of working in complex products / Gx Nebulizer / combination, SOD area in current environment, strong technical strength and the ability to think outside of the box/creative approaches without risking submission quality 

 
Skills:

  • Demonstrates a thorough knowledge and understanding of all FDA regulations, guidelines 
  • Strong skills in understanding of cross functional interactions needed by RA to compile comprehensive submission is a must 
  • Experience in R&D and Quality dealing with Chemistry, manufacturing, and controls
  • Demonstrates the ability to take the lead in responding and resolving deficiencies in a manner acceptable to both FDA and affected departments
  • Demonstrates advanced oral and written communication skills including editing of documents prepared by others 

Education:
University - Master's Degree

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