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Sr Associate Regulatory Affairs – CMC

Thousand Oaks, CA
aTop 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 (a very large organization and there will be many parties the candidate will need to engage with for project success).
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.

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

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.
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;
Commitment of a 40-hour work week in Thousand Oaks, California
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

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

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