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

Required Qualifications and Experience

• Bachelor’s degree or above in pharmacy, pharmaceutical sciences, chemistry, toxicology, biology, food science, chemical engineering or another relevant scientific discipline; advanced degree is preferred for leadership readiness.
• Typically ten or more years of progressive experience in regulatory affairs, product stewardship, quality, technical service or compliance within pharmaceuticals, pharmaceutical excipients, APIs, specialty chemicals, food/nutrition, personal care or another regulated industry.
• Demonstrated working knowledge of India regulatory requirements, with practical exposure to South Asia and selected Rest of Asia frameworks relevant to pharmaceutical excipients, APIs, food or nutrition ingredients, personal care ingredients and specialty additives.
• Strong product stewardship and hazard communication experience, including practical knowledge of GHS classification principles, SDS and label requirements, chemical inventory status, dangerous goods interfaces, restricted substance management and customer product safety documentation.
• Proven ability to manage customer regulatory support, product compliance assessments, regulatory intelligence, registration or notification activities, change-control impact assessments and cross-functional deliverables with limited supervision.
• Strong business judgment and communication capability to convert regulatory complexity into practical recommendations for commercial, quality, supply chain and senior leadership stakeholders.
• Experience responding to customer regulatory or quality requests and coordinating information across multiple functions.
• Excellent written and verbal English communication skills; local Indian language capability is beneficial for customer, authority or market engagement where required.
• Demonstrated ability to manage multiple priorities, meet commitments and work effectively in a regional matrix organization.

Preferred Leadership Differentiators

• Master’s degree or professional qualification in a relevant scientific or regulatory discipline.
• Direct experience with pharmaceutical excipients, APIs, drug master files or equivalent technical dossiers, pharmacopeial requirements, excipient GMP expectations, product safety documentation and customer regulatory declarations.
• Knowledge of India, South Asia and selected Rest of Asia regulatory pathways for life sciences, nutrition, personal care or specialty additive products.
• Experience supporting registrations, authority interactions, audits, change controls and regulatory impact assessments.
• Background in analytical testing, specifications, methods, toxicology or quality systems.
• Experience working with SDS authoring systems, hazard communication databases, chemical control inventories, transport classification inputs, toxicological data summaries or SAP-based product compliance workflows.
• Experience with SAP, Salesforce, document-management systems, regulatory information-management tools, workflow platforms or data reporting solutions.
• Additional Asian language capability relevant to the assigned markets.

Technical Knowledge and Professional Capabilities

Capability

Expected demonstration

Regulatory judgment

• Interprets requirements carefully, differentiates obligations from guidance, documents rationale and recognizes when escalation is needed.

Scientific and technical competence

• Understands product composition, specifications, manufacturing information and safety or quality data sufficiently to develop accurate regulatory positions.

Product stewardship and hazard communication

• Understands hazard classification, SDS and label governance, restricted substance considerations, chemical inventory impacts and product safety documentation sufficiently to guide compliant business execution.

Customer focus

• Clarifies the underlying need, provides practical compliant solutions and communicates timelines, constraints and alternatives transparently.

Execution and accountability

• Plans work, prioritizes by risk and business need, follows through on commitments and maintains complete records.

Communication and influence

• Converts complex requirements into clear actions; listens actively; presents confidently; and adapts messages for technical and non-technical audiences.

Collaboration

• Builds trusted relationships, works across organizational boundaries and resolves differing perspectives constructively.

Learning agility

• Rapidly develops knowledge of new jurisdictions, products and tools and remains effective as priorities and regulatory landscapes change.

Continuous improvement

• Uses trends, root-cause thinking and stakeholder feedback to simplify work and strengthen quality, speed and consistency.

Integrity

• Protects confidential information, communicates evidence accurately and raises concerns promptly and respectfully.

Measures of Success

• Timely completion of customer requests and regulatory deliverables against agreed service levels and project milestones.
• Accuracy, completeness, consistency and appropriate approval of released regulatory documentation.
• Effective closure of regulatory intelligence actions, registration commitments, audit actions and assigned project tasks.
• Accurate and timely completion of SDS, label, hazard classification, chemical inventory, restricted substance and product safety documentation activities within assigned scope.
• Quality of stakeholder feedback and contribution to customer experience, market access and business continuity.
• Demonstrated reduction of recurring requests, rework or process gaps through standardization, training and continuous improvement.
• Compliance with Ashland policies, applicable requirements, data-integrity expectations and records-management practices.

Role Conditions and General Expectations

• Ability to collaborate across countries, cultures and time zones and to participate in calls outside standard local business hours when reasonably required for regional or global coordination.
• Ability to travel regionally as required for business meetings, customer support, audits, industry engagement or training.
• This job description describes the principal purpose and responsibilities of the role. Duties may be adjusted based on business needs, organizational changes and applicable local requirements.
• Employment terms, location arrangements, physical requirements and any country-specific legal language are subject to review and approval by Human Resources and Legal.

In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer.

At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do.

Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty.

Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit.

Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.