Associate Regulatory Affairs - CMC JP10136
Associate Regulatory Affairs - CMC JP10136
Posted on :
16-03-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
16-03-2025
Job Description
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 anAssociate Regulatory Affairs CMCfor 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:
Why is the Position Open
Supplement additional workload on team.
Top MustHave Skill Sets:
Day to Day Responsibilities:
Daily responsibilities will be focused on providing submission support to products across modalities regions and phases of development.
Red Flags:
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 youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
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 anAssociate Regulatory Affairs CMCfor 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 40hour work week in Thousand Oaks California.
- Bachelors or Masters 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 MustHave Skill Sets:
- Cando 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 inbetween 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 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 youre not interested in pursuing this position please feel free to look at the other positions on our websitewww.3keyconsulting/careers. You are welcome to also sharethis opportunity withanyone you think might be interested in applying for this role.
Regards
3KC Talent Acquisition Team
Required Experience:
IC
Employment Type
Full Time
Key Skills
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