Regulatory Affairs Analyst
Northbrook, IL 60062
Schedule: Full-time (40 hours/week)
This position will be accountable for monitoring, analyzing and determining legislative and regulatory changes which impact in our estrategy projects. Coordinate implementation of changes including drafting of communications to the team. Work across operational areas such as CMC, labeling and PPM.
ESSENTIAL JOB RESPONSIBILITIES:
• Compile information to create a Regulatory Contain Planner per country
• Compile and arrange information from different sources to develop a tentative plan in order to provide a prespective of the needed documents.
• Follow up the regulatory projects to the international regulatory processes.
• Archiving the despached, submitted and approved documents. Keeps updated records (e.g. spreadsheets, systems).
• Country-specific regulations and local environments to assess impact and provide guidance.
• Works closely with functional areas throughout the company.
• Advises functional areas regarding content requirements for Markets regulatory submissions;
• Distributes, sends and follows up emails, letters and documents (CCDS, CC, PSURs) to BP /stakeholders.
• Requests translation to the vendors.
• BS/BA Degree in a scientific discipline.
• A minimum of 2 years of directly related regulatory experience in pharmaceutical field or related .
• Excellent written and oral communication skills required (English/Spanish)
• Organizational skills with detail orientation.
• Solid computer skills in MS Office (excel, MS, words)
• Demonstrated ability to coordinate complex projects