ChemBio Regulatory Specialist M/F/D

Job Description

We are seeking a highly motivated and detailed-oriented ChemBio Regulatory Specialist to play a crucial role in ensuring Agilent ChemBio products and processes comply with all relevant global chemical and biological regulations. As a key member of Chemical Regulatory Team, she/he will be responsible for interpreting chemical and biological regulations, developing and implementing product compliance processes, supporting new product introduction (NPI) regulatory compliance activities, and maintaining the product compliance through the product life cycle.

Responsibilities:

• Interpret and apply international, federal, state, local regulations related to chemical (e.g., US TSCA, EU REACH/CLP, ODZ, F-Gas, SAPK regulations, GHS, etc.) and biological substances (e.g., USDA-APHIS, AU-DAFF, NZ-MPI, EU Animal By-Products, etc.), provide expert guidance on complex international chemical and biological regulations.
• Oversee the activities for critical global regulatory reporting, registrations, and notifications. Provide expert guidance on development, review, and approval of Safety Data Sheet (SDS), GHS labeling, and risk assessment for Agilent’s global ChemBio product portfolio.
• Actively engage with Regulatory Intelligence team for ChemBio products, proactively identifying emerging regulations and assessing their potential impact. Develop and implement proactive risk mitigation strategies to ensure continuous compliance and market access.
• Serve as a recognized expert on ChemBio product regulations within Agilent. Provide strategic guidance to cross-functional teams and represent Agilent in industry forums and regulatory discussions and engage in chemical and biological regulation policy discussions to advocate Agilent’s interests.
• Work closely with supporting divisions to ensure the ChemBio product NPI is successfully launched and in compliance with the applicable chemical and biological regulations in the addressed markets.
• Proactively engage with R&D to ensure new ChemBio product development aligns with evolving global regulatory requirements, provide expert input to facilitate successful market introduction.
• Develop and deliver expert training on global product regulations.
• Develop and maintain the ChemBio regulatory compliance related processes. Support ChemBio compliance tool development and implementation.
• Provide regulatory guidance relative to managing ChemBio regulatory inspections and appropriately responding to any requests and inquiries from authorities and stakeholders.

Qualifications

• Bachelor’s or Master’s Degree or equivalent in Chemical Engineering, Chemistry, Biochemistry, Molecular Biology, Biochemical Engineering, or a closely related field with a strong emphasis on chemical and biological regulations. Professional certification in the regulatory area is preferred.
• Minimum 8 years of progressive experience in ChemBio regulatory compliance focused on chemical and biological substances and/or ChemBio products within a multinational chemical, life science and diagnostics, analytical chemistry, or related industry.
• Deep and comprehensive understanding of a wide range of global chemical and biological regulations (e.g., TSCA, REACH/CLP, GHS, GMO, USDA-APHIS, AU-DAFF, EU Animal By-Products, and other country specific chemical and biological regulations, transportation regulations). Strong understanding of global supply chain regulations related to ChemBio products. 
• Strong track record of providing regulatory compliance support for NPI and product life cycle management.
• Must have an expert knowledge of Enterprise Compliance Software Solutions, preferably with a strong track record of implementing the SDS, GHS, and Chemical/Biological Database-related software.
• Proven ability to lead and mentor cross-functional teams and drive impactful regulatory initiatives in a complex, matrixed global organization.
• Demonstrated ability to proactively identify emerging regulatory trends and translate them into strategic opportunities or risk mitigation/implementation plans.
• Active participation in relevant industry associations or regulatory working groups. Experience in advocating for company positions on chemical and biological regulations with agencies.
• Experience in managing and leading global regulatory audits and inspections is preferred
• Familiarity with Agilent products and the markets Agilent serves is preferred.

Personal Characteristics:

• Exceptional analytical, data-driven, risk-based, and problem-solving skills with the ability to navigate complex international regulatory landscapes.
• Outstanding written and verbal communication, presentation, and negotiation skills, with the ability to influence and engage effectively with senior leadership, regulatory authorities, and diverse global teams.
• Comfortable working with international teams and navigating the complexities of diverse regulatory environments.
• Ability to identify, understand, and focus on key business priorities.
• Adherence to the highest ethical standards and ensure regulatory activities are conducted with transparency and honesty.
• Effectively working with cross-functional teams to build strong relationships and foster a shared understanding of regulatory requirements and responsibilities.
• Self-starter, team-player, and continuous-learner.

We Offer:

• Motivated Teams: Collaborate with highly motivated teams and take on exciting responsibilities.
• Challenging Projects: Engage in dynamic, collaborative projects.
• Development Opportunities: Benefit from diverse opportunities for professional growth.
• Corporate Culture: Be part of an exceptional corporate culture.
• Work-Life Balance: Enjoy a good work-life balance.
• Competitive Compensation and Benefits: Receive a competitive compensation and benefits package.
• Hybrid Work: Work in a hybrid model (3 days in the office, 2 days from home).
• Permanent Contract: Secure a permanent contract with a fast-growing global company.

If you have any further questions regarding the application process, please contact the recruiter at +34 933 445 804.

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely.

Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: https://careers.agilent.com/locations

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.Travel Required: 10% of the TimeShift: DayDuration: No End DateJob Function: Quality/Regulatory