Job title: Regulatory Affairs Specialist Project Lead I Duration: 6 MONTHS REMOTE
HM Notes: Mon - Fri 9 AM - 1 PM EST (slight flex offered for different time zones) Candidates must be located in the US Possibility of extension Must-Have Skills: • 3-6 years of related experience in a pharma regulatory-related role open all therapeutic areas (not manufacturing), non-CMC experience • Open to previous Sr. or Leadership exp • Fluent with online searches/ research • MS Office - Excel, PowerPoint • Ability to create decks/ presentations Nice to Have Skills: • Writing, analyzing data, write-ups of research/ searches
SCOPE OF RESPONSIBILITIES: • accountable for supporting regulatory policy efforts within the Regulatory Science and Policy team • will be at ease working in a matrix environment and be able to navigate ambiguity to drive decision-making working across teams DUTIES: • Work with regulatory leads through cross-functional team support on both strategic and tactical product issues & opportunities including matters related to policy, product/project strategy, FDA engagement, and other external engagement efforts • Ensure effective execution for new innovative consumer-centric products and the life cycle management of products in the portfolio across the following regulatory classes (OTC monograph drugs, dietary supplements, cosmetics, foods, and medical devices)
Responsibilities: • Monitor emerging regulatory policy issues, including issues arising from North American regulatory authorities, legislatures, within the pharmaceutical industry or elsewhere, and identify those issues likely to impact client’s R&D pipeline, regulatory strategy or product portfolio. • Provide relevant ad hoc regulatory intelligence to internal stakeholders. Effectively communicate impact and bring awareness of business-critical issues for informed decision making, and work with subject matter experts within the company to assess impact on client’s products and goals. • Coordinate and lead internal teams to develop client responses and comments on draft legislation, regulations, guidelines and regulatory policies issues. Liaise closely with colleagues (R&D, External Affairs, etc.) leading policy activities in the external environment to facilitate regulatory input and overall alignment on client position. Plan and manage interactions and communications with trade associations and health authorities on regulatory policy matters. • Lead proactive advocacy efforts for Sclient’s priority regulatory policy areas. Consult with internal experts and leadership to identify priority issues. In collaboration with internal experts and stakeholders, coordinate company policy positions across stakeholder groups, identify or create opportunities for engagement with regulatory authorities and trade associations, and execute on proposed strategies.
Education, Experience and Skill Requirement
• Minimum B.S.; M.S., Pharm D, MD, PhD or equivalent preferred • Minimum 3 years in Regulatory Affairs • Established regulatory experience • Effective collaboration • Familiarity and understanding of the drug/biologic development and commercialization process • Excellent written, oral, and presentation communication skills; Excellent command of English (written and spoken) • Superior time management and organizational skills. • Ability to lead multiple complex initiatives (short, mid and long-term). • Self-motivated, prone to action and results oriented. Provides an engaging and motivating work environment.
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: $85.00/hr.
