The candidate will support the Global Product Stewardship Lead to help develop, implement and maintain the procedures and processes for product environmental regulatory requirements such as REACh, RoHS, Packaging and Batteries Directives, Safety Data Sheets (SDSs) and other chemical regulations.
Product Regulatory Compliance (95%)
The candidate will:
• Be responsible for implementation of procedures and processes for product regulatory compliance efforts.
• Support the team in coordinating implementation of processes with in the EHS group as well as coordinate with other functional groups on integrating the business requirements.
• Support regulatory compliance programs such as GHS for safety data sheets for APIs, Bulk Drug Substances and Final Drug Products (FDP). Other programs include but not limited to REACh, TSCA, California Prop 65, Conflict Minerals etc.
• Track of global product regulations along with developing applicability analysis based on the country specific requirements for our raw materials, intermediates and products focusing on US and Asia Developing communication tools to provide to cross functional teams and support implementation of such requirements.
• Support development/implementation of automated systems/processes for regulatory tracking, evaluating sales and compliance data for applicable reporting globally. Activities will include development and review of restricted, prohibited substances within raw materials and products which can be provided to R&D and PDTS groups as products are being developed through the stage gate process.
• Support the development and implementation of the packaging and batteries requirements and database.
• Support the Product Stewardship-EHS team in completing New Product reviews and Management of Change (MoC) requests.
• Coordinate, participate and facilitate meetings and discussions, supporting the Global Product Stewardship Lead, with cross functional groups within R&D, Engineering, Procurement, Supply Chain, PDTS and other functions as needed to ensure cross-functional implementation of processes throughout the product development cycle.
• Support the Product Stewardship team in Europe, as needed, to provide necessary information to meet compliance
• Support the development and update of Microsoft Share Point site or similar platforms in implementing training, communication tools, procedures and processes to communicate with cross functional groups and internal EHS group. Support the group's KPIs and metrics related to product stewardship along with providing progress on projects and tasks.
• Develop regulatory content for presentations, webinars and other forums for communication as applicable.
• Communicate with the Global Product Stewardship Lead and other team members on any roadblocks and issues in meeting timelines, regulatory compliance obligations etc.
General EHS Responsibilities (5%)
• Responsibilities may involve assisting the EHS group with the development and deployment of EHS requirements or program initiatives, contributing to EHS functional teams, participating on EHS facility audits / focused program assessments, and other duties as assigned.
Education & Experience Requirements
• A BS degree in Environmental Studies/Management or in a technical degree such as chemistry, engineering, etc. is required.
• At least 3 years of experience in leading compliance programs for RoHS, WEEE, Packaging, REACH, GHS and Conflict Minerals or other product environmental regulations.
• The candidate will have minimum 5 years of relevant industry, corporate or consulting experience in this field.
• An MS degree in a related field is a plus.
• Knowledge of EHS compliance regulations such as waste, wastewater, DOT, IATA and other HazMat regulations.
• Experience with ISO 14001/OSHAS 18001 management systems
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.
Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.