JOB TITLE : Regulatory Compliance Manager – Chemicals
DEPARTMENT : Technology
The Regulatory Compliance Manager develops and delivers the company's global chemical regulatory compliance policy. (S)he ensures the completion of multiple REACH registration programs, ensuring systems and records in place to ensure REACH compliance, such as volume tracking.
Develops initiatives in regulatory compliance resulting in minimizing company risks and further professionalization of the company’s activities. (S)he will develop and manage a team of 2 – 5 regulatory specialists, and coordinate with applications and technical service teams to effect the execution of systems development initiatives. Travelling will be required for the position.
POSITION IN THE ORGANIZATION
The Regulatory Compliance Manager reports to the Vice-President, Technology and works closely with the regional Regulatory Affairs Representatives, regional applications teams, regional technical service personnel, and the global Technical, Commercial, Supply Chain and Business teams.
TASKS AND RESPONSIBILITIES
- The management of and regulating product registration in compliance with existing and emerging global legislation;
- Responsible for the management of registration of our products under REACH TSCA, NICNAS, BfR, Swiss list and other national and regional regulatory and compliance structures. compliance of traded and manufactured product. Highlighting any discrepancies and coordinating to correct .
- Responsible for managing the preparation and development of product dossiers for submission to REACH, BfR and other compliance legislations. This includes the selection and management of specialist consultants and testing houses to develop both data and strategies for said dossiers
- Represents the company in front of compliance organizations such as BfR and organizations working for the regulatory advancement of uv curing products such as RadTech Europe and EuPIA
- Providing and coordinating support to our manufacturing center in Mortara for ReACH raw material issues
- Responsible for regulatory info gathering (NPI etc) and registration of products ( with consultants when required) on global inventories as per business need. Coordinates with, and advises, regulatory personnel in Asia, Brazil and the US in this aspect of the role.
- Maintenance of regulatory information on product database., including but not limited to the RIS system
- Development of databases to inform commercial teams and customers in support of product compliance
- Coordinating support to commercial teams for product compliance-focused customer requests (customer questionnaires and individual questions), suppliers, agents, distributors, and IGM team members;
- Managing the authoring of GHS and CLP compliant MSDS and labels for all business units ( IGM and Pharma). Ensure documents are always compliant with latest regulations and any changes are communicated internally and externally;
- Manages the development and maintenance of a software-based SDS system
- Liaises with, and manages the use of external regulatory and toxicology consultants to ensure regulatory projects on target and on budget and all new and existing materials are compliant with REACH, BfR and other compliance legislations
- Familiarity with SIEF and consortium for REACH
- DGSA advisor, work with compliance officer on safety issues and internal training.
- Influences the new product development process, both through internal consultancy to product management and technology as to the feasibility of securing worldwide regulatory compliance for proposed new chemicals and mixtures, and through the regulatory sign-off on all major development projects managed under IGM’s Stage Gate system. He/she is a core member of all major new product development teams.
- Management, coaching and training of a European-based team of 2 – 5 regulatory specialists
- Sets and evaluates goals for his team and communicates regularly to his team members on their achievements
- Represents IGM at technical conferences, as required, presenting on technical and regulatory issues
- Perform other duties as requested and works in accordance with company rules and regulations;
Education and experience
- Bachelors level Chemistry and General Science, preferably with a Master’s in Chemistry and/or an MBA.
- Minimum of 10 years working experience in an international organization in a similar position focusing on regulatory affairs, and on technology or technical service, advantageously in the UV Radcure industry.
- Familiar with REACH, CLP/GHS, international regulations and legislations, General Product Safety (Food- contact and Product Safety Authority), industry bodies such as Radtech and EuPIA.
- Familiar with ISO 9000, ISO 14000 and ISO 18000
- Qualified DGSA.
- Fluent in English.
Software knowledge requirements
- Working knowledge of MS Office
- Position specific software (e.g. regulatory and technical search engines).
- Able to organize your own work.
- Able to organize and prioritize the work of others
- Able to report progress on all projects and issues on a timely basis to his manager
- Clear customer focus
- Well developed communication skills
- Commercial and business insight.
- Able to anticipate and keen on monitoring progress.
- Has the “plan–do–check–act” attitude.
- Able to identify and enunciate both strategic and tactical opportunities to enhance IGM’s business and standing