Senior Specialist, Restricted Substances

About the role

This position will be responsible for developing, implementing, and maintaining restricted substances management (RSM) regulatory requirements such as EU REACH, EU RoHS, US Conflict Minerals, China New Chemical Registration, Canadian Chemical Management Plan, Proposition 65, etc.

Responsibilities

• Independently organize, develop, implement, and manage assigned aspects of existing- and novel RSM chemical regulatory projects. This includes outlining scope, time and resource management, communications, and risk mitigation throughout the project. Assigned aspects include interpreting regulatory requirements, creating an actionable business process, implementing the process, and demonstrating necessary compliance.
• Ensure RSM compliance is considered as part of long-term and short-term planning, including lifecycle management and new product introduction
• Implement strategies and action plans for Restricted Substances (RS) activities Develop, track, and communicate progress against program milestones and deliverables
• Work collaboratively with appropriate organizations to facilitate RSM implementation and compliance through the communication of RSM issues and development of process and tools
• Communicate chemical regulations requirements for the markets in which AbbVie places pharmaceutical, device, and cosmetic products; critically evaluate product- and supplier documentation to understand compliance risk
• Prepare and update guidelines, policies, procedures, and other documentation to ensure consistent implementation across multiple AbbVie sites and functions. Work to incorporate global chemical regulations appropriately within AbbVie's existing systems and functions.
• Handle multiple projects of various complexity in parallel
• Interact internally, across multiple functional areas, and externally, with Suppliers and Third Party Manufacturers, to obtain restricted substances supporting data to justify business and regulatory needs. Data must be well-organized and stored within existing AbbVie systems.
• Review and analyze component and sub-assembly information, assessing for restricted substances impact

Qualifications

• Proven leadership ability and excellent communication skills
• Self-starter able to work with minimal supervision; results oriented; strong workload organization- and problem-solving skills
• Have strong knowledge of today's key global restricted substances regulations (e.g. EU RoHS, EU REACH); familiarity with pharmaceutical R&D, pharma manufacturing/TPM, and supply chain activities
• Demonstrated team player with ability to work collaboratively with RSM team and functional counterparts in a global environment; ability to influence and solicit cooperation (internally and externally) to meet program objectives
• Strong program management skills and techniques (i.e. plans, schedules, presentations, etc.)
• Competency with Microsoft software suite (e.g. PowerPoint, MS Word, Excel, Outlook)

Education / Experience

• Bachelor's degree in a science or technical-related field is required
• A minimum of 5-10 years of experience in pharmaceutical industry in areas such as medical affairs, R&D, manufacturing, engineering, supply chain, etc...
• Minimum of 8 years' experience in Restricted Substance Management or similar chemical regulatory field
• Excellent presentation skills, proven problem-solving skills, strategic thinking

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this roleat the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs. Note: No amount of pay is considered to be wages or compensation until such amount isearned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits thatare allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole andabsolute discretion, consistent with applicable law.