Regulatory Affairs Labeling Associate Level – I is needed to support Client’ business to prepare and review regulatory labeling deliverables based on Reference Listed Drug labeling, FDA Guidance, regulation and Client internal practices.
Support labeling review process with a Quality Assurance and data integrity mindset.
Apply team concept to get things done and work collaboratively with everyone with transparency.
Applying strategic thinking, pharmaceutical educational knowledge, and regulatory intelligence during preparation and review.
Utilizing technical skills for learning new features and /or applications software which can support preparation and review activities.
Some key traits, should have Pharmaceutical Experience, worked in control environment to follow process, quality focus.
An effective communicator and can work independently and collaboratively with everyone, additionally, having Generic labeling experience is a plus.
Education:
Bachelor's or Associate’s degree in a scientific or English discipline.
Experience:
Bachelor’s degree plus a minimum of 1 -2 years in the pharmaceutical industry with 1 of those years working with labeling, conducting reviews or Associate’s degree plus a minimum of 3-4 years pharmaceutical industry experience working with labeling, conducting reviews.
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: $50.00/hr.
