Job Title: Associate Regulatory Affairs - CMC - (JP10083) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: CMC Core Team Duration: 1+ years (with likely extensions) Notes: Remote Posting Date: 04/13/2022
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; OR High school diploma / GED and 8 years of either Regulatory, 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.
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.
Leaving assignments before projects are complete
Unexplainable time gaps in resumes
References that are not from recent employers
References that are not direct supervisors
Phone screening followed by in-person interview.
We invite qualified candidates to send your resume to email@example.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.