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Senior Associate Regulatory Affairs CMC - REMOTE - (JP9542)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:   Senior Associate Regulatory Affairs CMC - REMOTE - (JP9542)
Location: Thousand Oaks, CA. (100% REMOTE)
Employment Type:  Contract
Business Unit: RA CMC Regions and Sites
Duration: 1+ years (with likely extensions and/or conversion to permanent)
Posting Date: 12/07/2021


3 Key Consulting is hiring a Senior Associate Regulatory Affairs for a consulting engagement with our direct client, a leading global biopharmaceutical company.

Job Description:
  • 100% remote.
  • Flexible schedule will need to adhere to Pacific coast hours,
  • 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.

Top Must Have Skills:
  • 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.
  • 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 (client 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.

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


Basic Qualifications:
  • 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.

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 client processes that support the making of human therapeutics and the patients that use them. Opportunity to grow your regulatory knowledge, covering raw material packaging for clinical and commercial product. Will broaden critical thinking.

Red Flags:
  • Lack of CMC experience.
  • Short contract durations.
  • 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:
Video Skype Panel Interview


We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
 
 
Regards,
 
3KC Talent Acquisition Team
 
 
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