Summary:
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.

Daily Responsibilities:

• Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development
• Employee Value Proposition
• You will work directly with project teams in support of submission execution.
• The projects you will be involved with will have a positive impact on key company processes that support the making of human therapeutics and the patients that use them.

What we are looking for:

• 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

Experience:

• Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience OR High school diploma / GED and 8 years of Regulatory (CMC preferred), 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 and Project

Top 3 Must Have Skill Sets:

• Experience in Manufacturing and/or Quality Assurance
• Organized
• Flexible

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 a number of factors, including but not limited to, a candidate's qualifications, skills, 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.