Associate Regulatory Affairs - CMC; JP

Position: Associate Regulatory Affairs - CMC (JP10136)
Job Title:Associate Regulatory Affairs - CMC (JP10136)
Location:Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit:CMC Core Team
Duration:1+ years (with likely extensions)
Posting Date:05/10/2022

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

Job Description:
We are looking for candidates who have a science background, either a background in quality QA/QC, manufacturing, lab, who are interested in Regulatory Affairs.

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.
• Bachelor’s or Master's degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience OR Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience
• 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.

Why is the Position Open?
Supplement additional workload on team.

Top 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 (Amgen 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.

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. Panel interview for those who pass the phone screening. We can start interviewing immediately and will be available as needed.

We invite qualified candidates to sendyour resume to. Ifyou decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our  You are welcome to also sharethis opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr