Associate Regulatory Affairs-CMC

Fully remote

Copy of AMAGJP00012351- no previously presented job seekers. Job seekers should be screened, have fully reviewed the job description and be able to speak to why they want to work in regulatory affairs/ CMC. This was a big miss on the last posting.

• Pre screening responses from job seeker are required at the top of the resume. The resume will be immediatley rejected if the pre screening questions are not included:
• Why do you want this role?
• How has your previous professional and educational experiences prepared you for this role?
• Based on the job description, what do you understand this role to be?
  
  

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

Commitment of a 40-hour work week

Experience o Bachelor's or Master degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience OR Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience OR 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