We are a global leader in the development and manufacturing of active pharmaceutical ingredients, focused on specialist niches with expertise in highly regulated and complex chemistries. Formerly part of Johnson Matthey, we have over 50 years of experience navigating the challenges of the global healthcare industry, and nurturing long-standing, trusted customer relationships. Operating within two divisions, Generics and Originators, we deliver a differentiated service offering to pharma and biotech customers for every stage in the drug development lifecycle.
The Product Stewardship and Toxicology Manager leads and manages product stewardship and toxicology activity through an inhouse team and external consultants, delivering product insight (regulatory and toxicological assessments) and assure regulatory compliance to drive our pharmaceutical portfolio management, including undertaking external representation and on behalf of the company.
The Product Stewardship and Toxicology Manager leads and manages product stewardship and toxicology activity through an inhouse team and external consultants, delivering product insight (regulatory and toxicological assessments) and assured regulatory compliance to drive our pharmaceutical portfolio management, including undertaking external representation and on behalf of company
Providing program and technical leadership of internal product stewardship and toxicology, via in house team and external consultants, ensuring operational compliance with chemicals control legislation
Managing a team of regulatory and toxicology professionals with consultants complimenting the in house team, responsible for managing product stewardship activities across the business, ensuring smooth business operations and continuity of supply through regulatory compliance
Make efficiencies in ensuring work packages for consultants are as necessary and delivered to time/budget
Access the cost and risk balance of outsourced team to internal team
Ensure preparation of toxicological assessments and impurity limit justifications in support or regulatory submissions for new or existing products in compliance with the most up-to-date expectations from the applicable Health Authorities
Raising business wide comprehension of product stewardship and toxicology issues by developing and carrying out training and communications
Interpreting, predicting, advising and supporting business on potential risk areas based on global legislation and hazards
Advancing the existing Product Stewardship Standards under the EHS Management Framework, in order to ensure clarity of responsibilities in the business, driving improvements and being the point of escalation to the Global EHS Director and business for issues with service delivery including compliance and cost
Developing and implement an internal governance program to allow for enhanced visibility of performance including internal audit process and KPIs
Acting as interface with external organizations and regulatory authorities on chemical product EHS compliance management and hazard issues
Ensuring REACH, TSCA and global chemicals regulatory compliance, and driving consistency of product hazard classifications and communication (safety data sheets and labelling), whilst safeguarding sensitive data
Ensuring knowledge and compliance for information on all generated SDS regarding transportation of dangerous goods globally
Owning the Business' selected SDS authoring system and ensuring sufficient technical and systems support through service contracts
Driving inclusion of Product Stewardship reviews in New Product Introduction framework in order to avoid launched product failures due to unrecognized hazards or regulatory constraints
To carry out any other duties which are within the employee's skills and abilities whenever reasonably instructed.
A degree qualification (Masters level preferred) in a discipline relevant to product stewardship, such as regulatory, occupational, or environmental toxicology.
At least 5 years’ experience of relevant product stewardship or toxicology (ideally both) in chemicals, or pharmaceutical industries and preferably in multi-national organizations.
Overall, 10 years’ experience in related roles with project management, science, technology or EHS in chemicals, or pharmaceutical industries.
Experience in key aspects of product stewardship work, with evidence of the practical application of toxicology technical skills, SDS authoring and driving compliance with REACH, TSCA and other product-related legislation for a complex product portfolio.
Experience of leading multi-disciplinary project teams and managing budgets and efficiency improvements, ideally in international organizations.
Working knowledge of global chemicals control and relevant product regulations.