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Associate Regulatory Affairs (CMC)

Thousand Oaks, CA
Top 3 Must Have Skill Sets:
    
Must have pharma/biotech experience, must have experience in some part of the drug manufacturing process (Manufacturing, QC/QA, analytical experience, etc.)

1. 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.
2. 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.
3. Attention to Detail – Ideal candidate will be thorough and deliver polished work product.

Description:

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;
• Qualified to work in the U.S. without employer sponsorship;
• Commitment of a 40-hour work week in Thousand Oaks, California
• Experience
o Bachelor’s or Master's degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience
o OR
o Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience
o OR
o 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 and Project

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

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