SPECTRAFORCE is Hiring a Regulatory Affairs Specialist Project Lead I Near Bridgewater, NJ
Job title: Regulatory Affairs Specialist Project Lead I Duration: 6 Months, Possibility for an extensionLocation: Fully RemoteWork Schedule M-F 8-5pm ET HM Notes
Fully Remote, open to candidates in all US time zones.
However, must be able to work M-F 8 AM - 5 PM ET time zone.
Must-Have:
Leadership capabilities and ability to work with cross-functional team
Knowing when to escalate concerns
Regulatory Experience, 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development
Nice Skills:
Advanced Degree
Filed marketing application (strong plus before)
DescriptionThis role will be accountable for leading the development and execution of innovative and value-added global regulatory strategies and be responsible for formulating the Global Regulatory Project Strategy (GRPS) for immunology products in Early Development. Additionally, this role leads the development of a global HA (Health Authority) interaction plan and strategy in collaboration with GRT (Global Regulatory Team) and is accountable for the communication of the key outcomes to senior management. Education And Experience
BS/BA degree in a relevant scientific discipline required. Advanced degree (PharmD, PhD, MD or DVM or MSc in Biology, Life Science, or related field) is preferred.
At least 8-10 years of relevant pharmaceutical/biotechnology experience in R&D, including at least 5 years of relevant Regulatory Affairs experience (regionally and/or global), in early development. 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.