Associate Regulatory Affairs - CMC

Summary:

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.

Requirements:

• 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
  
  

Top 3 Must Have Skill Sets:

• 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
  
  

Education and Experience:

• Degree in life sciences, biochemistry, or chemistry
• Experience working in a lab/ QA/ manufacturing environment are good fits for this role
• Experience in biopharmaceutical or pharmaceutical industry
• Familiarity with eCTD structure
• Experience in CMC, including preparation of submissions to Agencies
• Proficient skills in Microsoft Office suite
  
  

Compensation:

The pay rate range above is the base hourly pay range that Aditi Consulting reasonably expects to pay someone for this position (compensation may vary outside of this range depending on several factors, including but not limited to, a candidate’s qualifications, skills, competencies, competencies, competencies, competencies, experience, location and end client requirements).

Benefits and Ancillaries:

Medical, dental, vision, PTO benefits and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions.