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Reporting directly to executive leadership, the Regulatory Affairs Lead - Pharmaceuticals will lead as Regulatory Affairs for the company's increasing global sales and operations. This individual will work across the business to build, establish, and coach Regulatory compliance from scratch.
Our client is a dynamic medical device and life sciences manufacturer which has tripled its growth in revenue and headcount over the past several years. This organization is a complete market leader within its product ranges with operations spanning across the US, Canada, Europe and Asia.
- Build and sustain regulatory compliance for a diverse product portfolio and business practices
- Work to ensure facilities are properly licensed to distribute pharmaceuticals at the federal and state level, with understanding and in accordance of VAWD standards
- With the support of external consultants, work to ensure facilities are properly licensed to distribute pharmaceuticals at the federal and state level, with understanding and in accordance of VAWD standards
- Serve as key stakeholder in ensuring OSHA safety standards and compliance
- Drive programs and guidelines/practices that ensure compliance to include GMP and ISO
- Create policies and SOPs where needed to support compliance
- Other responsibilities as assigned
- BS Degree required
- Minimum 4 years of experience with US and international Regulatory Affairs
- Medical device or pharmaceuticals experience is strongly preferred
- Must have the ability to coach and train cross functionally for compliance - lead as a change agent within the organization
- Experience in VAWD accreditation, ISO, GMP, pharma compliance
- Impact player - first Regulatory hire in the organization with opportunity to build out entire function
- Partial remote work offered!
- Competitive compensation
- Huge growth potential for role and company
- High visibility to executive leadership
- Strategic decision-making role
- Fast-paced, start-up environment
- Excellent benefits package - health, dental, retirement, PTO, tuition reimbursement