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Sr Associate Regulatory Affairs – CMC

South San Francisco, CA

“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and PuertRictbe vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers 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 this company, its operations, or its staff.”

Top 3 Must Have Skill Sets:                                                            
  • 1-2 years work experience in Regulatory Affairs or Quality Assurance. CMC experience preferred. 
  • Work experience related biotech or small molecule product. 
  • Knowledge or work experience related CTAs, INDs, Marketing Applications and ICH CTD structure and format
Day Day Responsibilities:                                        
Preparation of CMC documentation support new Clinical Trial Applications, Marketing Applications, and Post-Approval variations for this company pharmaceutical products.

Summary
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support the regulatory Chemistry, Manufacturing and Controls (CMC) department, across countries 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, managing document reviews, and other tasks as requested.
What we are looking for:
Strong organizational skills with attention detail;
Proficient time management skills and ability prioritize workload;
Ability work both independently and as a member of a team;
Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
Qualified 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 tlearn quickly
Experience in CMC, including preparation of submissions tAgencies
Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project

Daily Responsibilities
Daily responsibilities will be focused on providing submission execution support tproducts 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 this company processes that support the making of human therapeutics and the patients that use them.
Red Flags
Leaving assignments before projects are complete
Unexplainable time gaps in resumes
References that are not from recent employers
References that are not direct supervisors
Interview Process
Phone screening of possible candidates. In-person interview for those whpass the phone screening. We can start interviewing immediately and will be available as needed.
Additional Onboarding Requirements
As this role is highly visible in nature, please send candidates that are personable and pleasant over the phone (e.g., you would hire them because they are a “people person”).

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

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