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Sr Associate Regulatory Affairs – CMC

Thousand Oaks, CA
“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:        
  • Must have direct CMC experience (RA CMC, Manufacturing, Quality Control, etc.).
  • Must be able to work independently and multi-task in a fast paced environment.
  • Experience working on biologics and small molecules, commercial and clinical is highly desired.
Day to Day Responsibilities:    
  • Assess manufacturing, supplier, analytical change controls for regulatory reportability.
  • Evaluate manufacturing deviations for impact to regulatory filings.
  • Partner with various functions to gather country specific documentation to support regulatory submissions.
Summary
  • Must have direct CMC experience (RA CMC, Manufacturing, Quality Control, etc.).
  • Must be able to work independently and multi-task in a fast paced environment.
  • Experience working on biologics and small molecules, commercial and clinical is highly desired.******
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;
Commitment of a 40-hour work week in Thousand Oaks, California
Experience
o Master's degree and 2 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
o OR
o Bachelor's degree and 4 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
o OR
o Associate degree and 6 years of Regulatory (CMC preferred), Compliance, Quality, Biopharmaceutical, Pharmaceutical and/or related scientific experience
o OR
o 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
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 (This Company is 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.
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 Thousand Oaks in support of submission execution. The projects you will be involved with will have a positive impact on key to rhis company processes that support the making of human therapeutics and the patients that use them.


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

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