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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive expertise in regulatory affairs, product stewardship, and compliance within the life sciences sector, with a strong focus on regional regulatory requirements and customer support. Proficient in managing regulatory documentation, product registrations, and cross-functional collaboration in a matrix organization.
Highest-signal resume keywords
Regulatory Affairs ExpertiseProduct StewardshipHazard CommunicationRegulatory Compliance AssessmentsStrong Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Document PreparationProduct RegistrationGHS Classification PrinciplesSDS AuthoringPharmaceutical Excipients KnowledgeAPIs UnderstandingGMP ExpectationsRegulatory Impact AssessmentsChange Control ManagementTechnical Dossier Development
Soft Skills
Strong Business JudgmentAbility to Manage Multiple PrioritiesCollaboration Across CulturesEffective Communication
Tools & Technologies
SAPSalesforceDocument-Management SystemsRegulatory Information-Management ToolsWorkflow Platforms
Certifications & Qualifications
Master’s Degree in Relevant Scientific DisciplineProfessional Qualification in Regulatory Discipline
Industry Keywords
Life SciencesRegulatory IntelligenceQuality ComplianceChemical Inventory ManagementDangerous Goods InterfacesCustomer Product Safety DocumentationMarket-Entry AssessmentsAudits and InspectionsTrade Association ParticipationRegional Regulatory Advocacy
About the role
Key responsibilities & impact- Provide regional leadership for Ashland’s Life Sciences portfolio across India, South Asia and assigned Rest of Asia markets
- Own and coordinate customer regulatory and quality inquiries across Rest of Asia
- Prepare, review and maintain regulatory documents, market-specific statements and customer-facing compliance information
- Support product registration, notification, listing, renewal, variation and maintenance activities
- Perform market-entry and product compliance assessments for assigned countries and product portfolios
- Develop regulatory technical packages, country dossiers, product compliance summaries and customer support materials
- Review product literature, sales presentations, technical claims, labels and commercial materials for regulatory alignment
- Support new product introductions, product and sourcing changes, manufacturing transfers, formulation or specification changes and discontinuations through regulatory impact assessments
- Lead and coordinate product stewardship, hazard communication, SDS and label governance activities
- Coordinate product composition, hazard, exposure, use, restriction and regulatory-status information with global and regional functions
- Monitor laws, regulations, guidance, standards and enforcement trends across assigned markets
- Prepare regulatory alerts, impact assessments, leadership summaries and action plans
- Maintain an auditable regulatory intelligence tracker
- Support audits, due diligence, inspection readiness, deviation, complaint, change control, CAPA and supplier or site qualification processes
- Support trade association participation and regional regulatory advocacy
- Maintain regulatory records, procedures, work instructions, templates, decision trees, FAQs and training materials
- Share knowledge across the Asia-Pacific and global Product Regulatory Affairs community and coach colleagues
- Escalate non-compliance, safety concerns, market-access risks, unsupported claims and matters outside delegated authority
Requirements
What you’ll need- Bachelor’s degree or above in pharmacy, pharmaceutical sciences, chemistry, toxicology, biology, food science, chemical engineering or another relevant scientific discipline
- Typically ten or more years of progressive experience in regulatory affairs, product stewardship, quality, technical service or compliance within a regulated industry
- Working knowledge of India regulatory requirements, with practical exposure to South Asia and selected Rest of Asia frameworks
- Strong product stewardship and hazard communication experience, including GHS classification principles, SDS and label requirements, chemical inventory status, dangerous goods interfaces, restricted substance management and customer product safety documentation
- 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
- Experience responding to customer regulatory or quality requests and coordinating information across multiple functions
- Excellent written and verbal English communication skills
- Ability to manage multiple priorities, meet commitments and work effectively in a regional matrix organization
- Master’s degree or professional qualification in a relevant scientific or regulatory discipline preferred
- Experience with pharmaceutical excipients, APIs, technical dossiers, pharmacopeial requirements, GMP expectations, product safety documentation and customer regulatory declarations preferred
- Experience supporting registrations, authority interactions, audits, change controls and regulatory impact assessments preferred
- Experience with SDS authoring systems, hazard communication databases, chemical control inventories, transport classification inputs, toxicological data summaries or SAP-based product compliance workflows preferred
- Experience with SAP, Salesforce, document-management systems, regulatory information-management tools, workflow platforms or data reporting solutions preferred
- Ability to collaborate across countries, cultures and time zones
- Ability to travel regionally as required
Benefits
Comp & perks- Industry competitive salary and benefits
- Pay-for-performance incentive plans
- Opportunities for development and advancement throughout the global organization
- Diverse work environment
- Dynamic and challenging work environment