Mar 12, 2018

Regulatory Affairs Associate

  • EasyHireJobs
  • Hobbs, NM, USA
Full time Engineering

Job Description

Hobbs , NM , United States 

Interact and negotiate with drug regulatory agencies (US and non-US) on assigned projects and manages the project activities of other regulatory staff assigned to projects under their authority.
• Serves as the primary Regulatory Affairs representative to assigned Product Development Teams(s) and interacts with other departments and with personnel from corporate partners.
• Participates in development of overall project goals and in particular those that pertain to regulatory affairs.
• Develops regulatory strategies and position papers for development candidates submissions drug regulatory agency meetings and special regulatory issues.
• Responsible for negotiations and interactions with drug regulatory agencies on assigned projects.
• Coordinates preparation of information and development of strategies for meetings with drug regulatory agencies.
• Responsible for managing the conduct of meetings when appropriate and responsible for meeting minutes.
• Responsible for organizing regulatory submission teams and coordinating the drafting editing and preparation of regulatory submissions (e.g. IND’s NDA’s annual reports IND amendments NDA supplements routine correspondence).
• Participates in the development implementation and enforcement of regulatory policy.
• Negotiations with and supervision of contract organizations employed for the preparation of regulatory submissions.
• Advises relevant corporate personnel regarding regulatory strategies potential areas of concern and new governmental/regulatory developments.
• Determines methods and procedures that are to be followed for projects assigned and may manage the activities of other regulatory staff assigned to their projects.
• Responsible for the regulatory evaluation of in-licensing candidates as assigned. Discretion/Latitude/Independence

REQUIREMENTS:
• Graduate degree in pharmacy life science or commensurate experience.
• 5+ years of related experience with at least 4-5 years of Regulatory Affairs experience with increasing responsibility.
• A Master’s Degree or PhD may partially substitute for work experience.
Experienced in the process of interacting with regulatory authorities.
• Knowledge of ICH/GCP GLP and GMP requirements.
• Must be able to effectively interact with internal and external customers to obtain accurate information and be a team player.
• Must posses the ability to manage multiple projects with competing deadlines. Compensation: The salary and benefit package will

• EDUCATION: Graduate degree in pharmacy or life science

• JOB DURATION: This job is full time and long term.

• COMPENSATION RANGE: 0/yr

Occupations

Biotechnology and Pharmaceutical

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