Description:

Remote- any US time zone is OK

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.

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 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 OR ed), 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

• Can-do Attitude – Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude.
• Being Comfortable With Being Uncomfortable – Ideal candidate will not only be able to identify problems but also identifies possible solutions. Project end goals will be known but all the in-between steps may not be known from the start so the candidate will need to navigate and structure the steps without being easily flustered.
• Attention to Detail – Ideal candidate will be thorough and deliver polished work product.
• General US regulatory experience, including US state license applications and submissions
• Experience with document management systems
• Experience with basic project management

Daily Responsibilities

• Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development

Pay Rate  between $31 - $36/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"