Overview Join our dynamic team as an Environmental Compliance and Policy Specialist, where you will play a vital role in ensuring our organization adheres to all environmental regulations and sustainability standards. This position will be a consultant position that offers an exciting opportunity to influence environmental strategies, develop compliance frameworks, and support the implementation of policies that promote responsible environmental stewardship. You will collaborate across departments to manage regulatory requirements, conduct detailed compliance analyses, and contribute to the development of innovative solutions that align with both legal standards and our corporate sustainability goals. Your expertise will help us navigate complex environmental regulations while fostering a culture of continuous improvement and environmental responsibility. Responsibilities Monitor and interpret environmental regulations including FDA regulations, EMA regulations, ISO 13485 standards, and ICH guidelines to ensure organizational compliance. Manage regulatory submissions related to environmental policies, ensuring accuracy and timeliness in documentation for agencies such as the FDA and other health regulation authorities. Conduct comprehensive regulatory compliance analysis across various projects, identifying risks and developing mitigation strategies aligned with pharmaceutical regulatory compliance standards. Lead initiatives on clinical trials related to environmental impact assessments, supporting research activities with a focus on health regulation policy knowledge. Develop, review, and update policies related to biomedical regulatory compliance, chemistry, manufacturing & controls (CMC), and drug regulation to maintain adherence to evolving standards. Utilize compliance management software to track regulatory compliance projects, generate reports, and facilitate cross-functional communication among teams. Support quality assurance processes by ensuring all environmental practices meet international standards such as ISO 13485 and other relevant guidelines. Collaborate with project teams on risk management strategies related to environmental impacts of pharmaceutical products and manufacturing processes. Provide training and guidance on regulatory compliance requirements to internal teams, fostering a culture of awareness and accountability. Experience A bachelor's degree in environmental science, environmental policy, natural resources, planning, public administration, engineering, or a related discipline is required. The individual shall have at least eight (8) years of experience supporting environmental compliance, National Environmental Policy Act (NEPA) analysis and documentation, environmental policy, permitting, regulatory review, or related environmental planning activities. Supporting cultural resources shall meet any applicable Secretary of the Interior professional qualification standards or other project-specific regulatory requirements, as applicable. Join us in shaping sustainable practices that meet rigorous health regulations while advancing innovative solutions in the pharmaceutical industry!
Pay:
$45.00 - $60.00 per hour Expected hours: 10.0 - 24.0 per week