Associate Regulatory Affairs

Job Description

The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development.

Support may include organizing, managing and executing on regulatory CMC projects in support of regulatory submissions.

Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested.

What We Are Looking For

• Desire to learn Regulatory Affairs CMC and global submission strategy.
• Strong organizational skills with attention to detail.
• Proficient time management skills and ability prioritize workload.
• Ability to work both independently and as a member of a team.
• Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project.
• Qualified to work in the U.S. without employer sponsorship.
• Commitment of a 40-hour work week.
  
  

Experience And Skills

• Bachelor’s master’s degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience
• Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience.
• High school diploma / GED and 8 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience Preferred Qualifications.
• Degree in life sciences, biochemistry, or chemistry.
• Experience in biopharmaceutical or pharmaceutical industry.
• Familiarity with eCTD structure ? Motivated with initiative to learn quickly.
• Experience in CMC, including preparation of submissions to Agencies.
• Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint.
  
  

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