Ashland has an exciting opportunity for a Quality and Regulatory Professional - Assistant manager to join our Life Science function at our Mumbai, Maharashtra. This is a very visible, significant role within the Company and the Life Sciences function. This position will report to Manager.
The Quality and Regulatory Professional - Assistant manager is responsible for:
Advocacy, Quality and Regulatory Strategy
- Navigate the people and processes of our commercial, manufacturing and supply chain organizations as well as the external landscape of regulatory agencies and industry groups to advocate on behalf of Ashland
- Represent Ashland on selected trade, industry, government, and/or technical organizations
- Monitor for changes in regulatory strategy at relevant agencies/authorities to identify potential impact to Ashland s agricultural business segments and LS BUs from emerging regulatory issues
- Interpret legislation and devise solutions to comply, mitigate unacceptable risk and create a competitive advantage for Ashland s businesses
- Define regulatory standards and assess impact to Ashland s commercial activities and operations
- Provide regulatory/quality customer webinars, trainings, and participating in customer`s meetings.
- Work as SME (subject matter expert) to support global, quality and customer`s requests support for agrochemicals and other LS BUs
- Support Quality related needs such liaison to support complaint management and oversight, retests requests, global customer sample requests, support as needed, stability program for the compliance point of view
- Create best practices, procedures, product regulatory and quality datasheets and documentation for Global LS requirements
- Review and approval of advertising materials
- Support Global LS projects and requests (i.e. Halal and Kosher regulatory and quality requirements, overall global submissions, regulatory intelligence, etc)
Enable Innovation and Sales
- Represent Product Regulatory to business leadership of the agricultural business segments to develop regulatory goals and objectives in alignment with business strategy
- Actively participate with Research & Development (R&D) as a regulatory expert in Ashland s INNOVA process for developing, piloting and scaling-up new products
- For INNOVA product launches: ensure all the required Quality and Regulatory customer facing documentation is completed, including the applicable Regulatory submission, serve as quality and regulatory project manager to oversee successful completion of the regulatory approvals, be a liaison between toxicology group and chemical management team to understand and support the entire life cycle and approval processes.
- Conduct regulatory reviews on formulations and compliance analysis for destination countries as a part of Ashland s New Product Introduction (NPI) process for commercializing new products
- Prepare and submit product regulatory registrations to relevant agencies / authorities / organizations as required to support sales and marketing in targeted geography and end-use application
- Engage directly with customers to support their regulatory activities relevant to qualifying and / or registering Ashland supplied products
- Develop standard product regulatory documents and statements to provide efficient indirect support to customers on frequently requested regulatory topics
- Review and approve advertising materials from a regulatory standpoint
- Provide support on quality processes, as examples: complaint management, retest requests, customer samples requests, test validations, stability program, etc.
Governance and Continual Improvement
- Lead with the courage and confidence to guide the company towards innovative solutions that leverage a risk-based approach yet deliver ethical decisions and products that are safe, suitable and compliant for their end-use markets
- Monitor regulatory activity and assess business impact to identify non-compliance issues or risks
- Engage and collaborate with internal and external legal counsel on matters of non-compliance
- Recommend and implement management programs and processes, including practices to support regulatory compliance and risk management activities
- Monitor program effectiveness and continually improve performance
