Regulatory Compliance & Technical Services Expert
The Regulatory Compliance & Technical Services Expert oversees regulatory, international environmental, health, and safety compliance functions within the Research & Development department.
This role ensures that all R&D activities adhere to internal policies, industry standards, and governmental regulations while driving innovation through effective technology management.
The ideal candidate will combine deep technical expertise with strong leadership skills to manage compliance risks and optimize R&D operations.
Key Responsibilities:
* Responsible for developing, implementing, and monitoring/horizon scanning of compliance programs related to Ireland R&D processes, ensuring adherence to relevant laws, regulations, and industry standards in both US and EU geographies.
* Manage and oversee technical services that support R&D activities, including chemistry lab infrastructure, software systems, IT solutions, and R&D EHS.
* Lead R&D Technical Services strategic capability investment projects.
* Lead, mentor, and develop a high-performing team of compliance and technical services professionals & specialists.
* Collaborate with Global R&D Functions to ensure that new product development meets compliance and quality standards.
* Ensure compliance with local, national, and international environmental, health, and safety regulations applicable to R&D ingredients, semi-finished goods, operations & projects.
* Drive continuous improvement initiatives related to compliance and technical service efficiency within the Ireland R&D function.
* Provide expert guidance on regulatory, EHS, and technical requirements during project planning, execution, and review phases.
* Lead audits, risk assessments, and investigations related to R&D compliance, ensuring timely resolution of any non-conformances or deviations.
* Develop and deliver training programs to enhance compliance awareness among R&D staff.
* Manage relationships with external regulatory bodies, technology vendors, and service providers.
Requirements:
* Bachelor's degree in Scientific disciplines, or related field; advanced degree preferred.
* Minimum 8+ years of experience in R&D compliance, analytical services, and/or technical services in regulated industries.
* Strong knowledge of regulatory frameworks and standards applicable to R&D activities (e.g., FDA, ISO 13485, GLP, GHS, ECHA).
* Proven experience managing compliance programs and technical operations in R&D settings.
* Excellent leadership, communication, and cross-functional stakeholder management skills.
* Ability to analyze complex regulatory requirements and translate them into actionable policies.
* Strong problem-solving skills and proactive approach to risk management.
* Experience with laboratory information management systems, validation protocols, and technical support tools is highly desirable.
Preferred Skills:
* Knowledge of the EU Regulatory environment.
* Familiarity with emerging testing and analytical technologies and digital tools in R&D.
* Experience in cross-functional collaboration in multi-national matrixed organizations.