Job Title: Associate Regulatory Affairs-CMC Duration: 1 Year Location: Remote
Details
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
Commitment of a 40-hour work week
Experience:
Bachelor's or Master 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
Basic Qualifications: Bachelor degree OR Associate degree and 4 years of experience OR High school diploma / GED and 6 years of experience
Top 3 Must Have Skill Sets:
Pre screening responses from job seeker are required at the top of the resume. The resume will be immediately rejected if the pre screening questions are not included:
Why do you want this role?
How has your previous professional and educational experiences prepared you for this role?
Based on the job description, what do you understand this role to be?
Can-do/Solution Oriented 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 (company 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.
Degree in life sciences, biochemistry, or chemistry
Experience working in a lab/ QA/ manufacturing environment are good fits for this role**
Experience in biopharmaceutical or pharmaceutical industry
Familiarity with eCTD structure
Experience in CMC, including preparation of submissions to Agencies
Proficient skills in Microsoft Office suite
Day to Day Responsibilities: Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development
Possible Extension: Yes
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
Formatting errors
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.
Note: The Company is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAhr@spectraforce.com.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation. At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $28.59/hr.
