Senior Associate Regulatory Affairs – CMC - Remote

Overview

The Senior Associate Regulatory Affairs (CMC) 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.

In Short

• Remote position available for any US time zone.
• Provide product support to regulatory CMC department.
• Organize and manage regulatory projects for submissions.
• Format documents and manage data from regulatory systems.
• Draft meeting agendas and minutes.
• Manage document reviews and other tasks as needed.
• Requires strong organizational and time management skills.
• Proficiency in Microsoft Office suite is essential.
• Experience in Regulatory Affairs or related fields preferred.
• Must be qualified to work in the U.S. without sponsorship.

Requirements

• Master's degree and 2 years of relevant experience, or equivalent.
• Experience in biopharmaceutical or pharmaceutical industry.
• Familiarity with eCTD structure is a plus.
• Ability to work independently and in a team.
• Strong attention to detail and positive attitude.
• Experience with document management systems.
• Basic project management experience is beneficial.

Benefits

• Competitive pay rate between $31 - $36 per hour based on experience.
• Flexible work hours across US time zones.
• Opportunity to work in a dynamic field of regulatory affairs.
• Gain experience in biopharmaceutical and pharmaceutical sectors.
• Supportive team environment for professional growth.