Manager Product Safety and Regulatory Affairs (South Asia)

Ashland India Private Ltd Position: Manager Product Safety and Regulatory Affairs (South Asia) Are you the kind of person who is always thinking, sketching, seeking, and adjusting? Who needs to understand how things work and then figure out how they can work better? Are you a passionate, tenacious solver who loves to work with others who share your drive? Are you positive, constructive, and ingenious? Are you always solving? Then we’d like to meet you and bet you’d like to meet us. Ashland has an exciting opportunity for an Manager Product Safety & Regulatory  to join our Regulatory team in Mumbai. The position will report to the Manager Regulatory Affairs APAC. This is an Onsite full-time position. Position Purpose This position is business-critical within APAC Product Regulatory Affairs and Product Stewardship, designed to sustain regulatory continuity, protect market access, strengthen customer-facing regulatory support, and ensure reliable product safety and hazard communication governance across India, South Asia and assigned Rest of Asia markets.   The role will provide regional leadership for Ashland’s Life Sciences portfolio, with practical support for adjacent Personal Care and Specialty Additives activities where business needs require, ensuring that product compliance, customer commitments, chemical hazard communication, SDS/label requirements, and regulatory risk management are executed with discipline and consistency.   Strategic Business Outcomes • Maintain continuity of critical regulatory support for India, South Asia and assigned Rest of Asia markets following transition from the           current role holder. • Enable business growth and revenue protection by supporting market access, product qualification, customer regulatory documentation, registrations and regulatory issue resolution. • Strengthen regional risk management by proactively identifying regulatory changes, compliance exposures, customer-sensitive topics and implementation actions. • Improve consistency, traceability and governance of customer-facing regulatory information through controlled documentation, clear approval pathways and evidence-based decision-making. • Provide reliable regional execution in a matrix organization, with measurable improvement in response quality, stakeholder alignment and project delivery discipline. • Scope of Accountability • Customer Regulatory Support and Business Enablement • Own and coordinate regulatory and quality inquiries from customers across Rest of Asia, including standard and non-standard requests, questionnaires, declarations, quality agreements, product compliance statements and supporting technical documentation. • Collect, evaluate and reconcile information from customers and internal subject-matter experts; identify information gaps; document the regulatory rationale; and deliver approved responses within agreed timelines. • Prepare, review and maintain standard regulatory documents and market-specific statements based on current requirements and business needs, including topics such as nitrosamines, elemental impurities, residual solvents, TSE/BSE, allergens, GMO status, irradiation, animal origin, pharmacopeial compliance and country-specific expectations, as applicable. • Apply appropriate document controls, approval pathways, confidentiality safeguards and version management to customer-facing regulatory information. • Escalate technically complex, high-risk, novel or potentially precedent-setting requests to the appropriate regional or global regulatory, quality, toxicology, legal or business owner. • Partner with Sales and Business Development to clarify customer requirements, set realistic delivery expectations and support strategic opportunities without overcommitting the organization. • Monitor request volumes, turnaround, recurring topics and service gaps; prepare periodic regional reports and recommend improvements to content, tools, processes and stakeholder education. • Support initiatives intended to strengthen customer experience, responsiveness and consistency across Rest of Asia.     2. Market Access, Registration and Product Compliance • Provide practical interpretation of pharmaceutical, food/nutrition and related product regulatory requirements and explain their potential impact on products, claims, customers, supply continuity and business plans. • Support product registration, notification, listing, renewal, variation and maintenance activities, as assigned, by assembling technical and administrative information and coordinating responses to questions from authorities, customers or localrepresentatives. • Perform or coordinate market-entry and product compliance assessments for assigned countries and product portfolios; clearly document assumptions, evidence, gaps, risks, decisions and follow-up actions. Develop and optimize regulatory technical packages, country dossiers, product compliance summaries and customer support materials that enable commercial execution. • Review product literature, sales presentations, technical claims, labels or other applicable commercial materials for alignment with approved regulatory information and applicable requirements. Support new product introduction, product change, sourcing change, manufacturing transfer, formulation or specification change, and discontinuation activities by providing timely regulatory impact assessments. • Participate in cross-functional projects and governance forums, representing Rest of Asia regulatory requirements and ensuring regulatory actions, owners and deadlines are documented and tracked. 3. Product Stewardship and Hazard Communication / • Lead and coordinate regional product stewardship activities for assigned products and markets, ensuring product safety, hazard communication and regulatory compliance considerations are integrated into business decisions. • Support hazard classification, SDS and label governance in alignment with applicable GHS-based requirements, local chemical control rules, transport classification inputs and Ashland internal standards. • Coordinate with global Product Stewardship, Toxicology, EHS, Quality, Manufacturing and Supply Chain to maintain accurate product composition, hazard, exposure, use, restriction and regulatory status information. • Review, maintain and improve customer-facing hazard communication materials, including SDS, product safety statements, chemical inventory status, restricted substance declarations, dangerous goods information and stewardship-related responses. • Assess the product safety and regulatory impact of raw material changes, supplier changes, manufacturing changes, new product introductions, formulation updates, specification changes and market expansion requests. • Identify and escalate potential hazard communication gaps, classification inconsistencies, missing source data, unsupported customer claims, restricted material concerns or issues that may affect safe use, transport, market access or customer commitments. • Promote consistent implementation of product stewardship principles across the region through guidance, training, work instructions, decision trees, process improvements and cross-functional alignment. 4. Regulatory Intelligence, Risk Management and Leadership Communication Monitor relevant laws, regulations, guidance, pharmacopeial developments, standards and enforcement trends across assigned Rest of Asia markets. • Assess the applicability, effective dates, business impact and implementation needs of regulatory developments; distinguish confirmed requirements from proposals or emerging expectations. • Prepare concise regulatory alerts, impact assessments, leadership summaries and recommended action plans for regional and global stakeholders. • Maintain an auditable regulatory intelligence tracker, including source, jurisdiction, topic, status, impact, owner, due date and closure evidence. • Use risk-based prioritization to identify potentially significant impacts on patient or consumer safety, product compliance, registrations, customer commitments, supply continuity and market access. • Contribute regional insights to global regulatory strategies and support harmonized implementation while recognizing legitimate country-specific differences. 5. Quality, Compliance and Readiness • Act as a liaison between Regulatory Affairs and Quality to address customer and business needs and ensure consistent use of approved quality and regulatory information. • Support internal audits, customer audits, due diligence and inspection-readiness activities by coordinating documentation, preparing subject-matter input and tracking assigned actions to closure. • Contribute regulatory input to deviation, complaint, change control, corrective and preventive action, and supplier or site qualification processes when regulatory impact is identified. • Promote data integrity, original-record traceability and evidence-based decision-making in regulatory records and customer communications. • Identify recurring compliance or process weaknesses and lead or support corrective and preventive improvements within the role scope.   6. Industry Engagement and Regulatory Advocacy • Support Ashland participation in relevant trade associations and industry initiatives by reviewing proposals, consolidating internal comments and providing scientifically grounded input. • Contribute to regional advocacy priorities related to pharmaceutical excipients, APIs, nutrition ingredients and associated quality or regulatory topics. • Prepare briefing materials and coordinate internal alignment before external engagement; communicate outcomes, commitments and follow-up actions to relevant stakeholders. • Represent Ashland professionally and in accordance with applicable competition-law, confidentiality and corporate communication requirements. 7. Process Excellence, Knowledge Management and Collaboration • Maintain current, accurate and retrievable regulatory records in approved systems and repositories; follow established naming, metadata, retention and access-control requirements. • Create and maintain procedures, work instructions, templates, decision trees, FAQs and training materials that improve consistency and efficiency. • Use available digital tools and data to standardize work, reduce manual rework and improve visibility of workload, risk and performance. • Share knowledge across the Asia-Pacific and global Product Regulatory Affairs community; provide backup coverage and coach colleagues on assigned markets or topics. • Demonstrate inclusive collaboration across cultures, functions and time zones and communicate complex scientific or regulatory matters in clear business language. Decision-Making and Escalation • Makes routine regulatory interpretations and prepares customer responses within approved procedures, precedents and delegated authority. • Recommends regulatory positions and risk-based actions based on applicable requirements, scientific evidence, product knowledge and business context. • Escalates potential non-compliance, patient or consumer safety concerns, material market-access risks, conflicts in source information, unsupported claims, authority commitments, legal-sensitive matters and requests outside delegated authority. • Does not release unapproved commitments, disclose confidential information, or provide legal advice. Key Working Relationships Stakeholder group Primary interaction Internal • Asia-Pacific and global Regulatory Affairs; Quality; Product Stewardship; R&D; Toxicology; Manufacturing; Supply Chain; Procurement; Sales; Business Development; Marketing; Customer Service; Legal; and Information Technology. External • Customers, distributors, consultants, testing laboratories, trade associations and regulatory authorities, within assigned responsibilities and authorization. Leadership Considerations for Candidate Profile