Job Title: Associate Regulatory Affairs - CMC (JP9908) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: CMC Regions & Sites Duration: 1+ year with likely extensions or conversion to FTE Notes: Onsite opportunity - Thousand Oaks, CA Posting Date: 03/09/2022
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: The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to 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 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;
Experience - Experience in biopharmaceutical or pharmaceutical industry - Experience in Regulatory Affairs or Quality Assurance in a regulated GMP Industry with a focus on CMC
Preferred Qualifications • Degree in life sciences, biochemistry, or chemistry • Familiarity with eCTD structure • Motivated with initiative to learn quickly • Experience in CMC, including preparation of submissions to Regulatory Agencies • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project
Why is the Position Open? Supplement additional workload on team
Top Must-Have Skill Sets: • 1-2 years work experience in Regulatory Affairs, or Pharmaceutical Industry • 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 • Attention to Detail – Ideal candidate will be thorough and deliver a 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: No actual work experiences
No direct experience in biopharmaceutical or pharmaceutical industry
Unexplainable time gaps in resumes
Candidates with only device regulatory experience
Interview process: Initial Phone Screen with hiring manager Second Phone Interviews with top ranking candidates
We invite qualified candidates to send your resume to email@example.com. If you decide that you’re not interested in pursuing this position, please feel free to look at the other positions on our website www.3keyconsulting.com/careers. You are welcome to also share this opportunity with anyone you think might be interested in applying for this role.