Senior Manager / Manager Regulatory Affairs

Job description

Job Location JAKARTA GENERAL OFFICE Job Description About the Role Join P&G Personal Healthcare as a Regulatory Affairs Senior Manager for Indonesia/ Philippines, where you will provide senior regulatory leadership for a diverse and complex Personal Healthcare portfolio, spanning Drugs, Health Supplements, Quasi-Medicines, Cosmetics, Food, and Medical Devices. This role is accountable for shaping regulatory strategies, enabling timely market access, ensuring sustained product compliance, and managing regulatory risks across the market. As the local regulatory expert, you will translate complex and evolving regulatory requirements into strategic business recommendations and lead regulatory decision-making across product development, registration, lifecycle management, artwork and labelling, promotional compliance, and commercialization. The role requires a high level of regulatory mastery, strategic judgment, and external influence. You will serve as a trusted advisor to senior business leaders and cross-functional teams, lead complex engagements with health authorities, and proactively shape the regulatory environment through credible, science-based regulatory advocacy. Where relevant, you will also provide leadership and coaching to Regulatory Affairs professionals and collaborate closely with regional and global teams to ensure local strategies are aligned with broader P&G priorities. Why Join P&G? At P&G, we develop trusted brands that improve the lives of consumers around the world. We empower our employees with meaningful responsibility from Day 1, providing opportunities to lead, influence decisions, and grow through challenging assignments. This role provides: Senior ownership of a diverse Personal Healthcare regulatory portfolio in Indonesia. Significant influence on business, innovation, and market access decisions. Direct engagement and strategic relationship-building with health authorities and industry stakeholders. Regional and global exposure within a leading multinational organization. Opportunity to shape regulatory strategies and influence the evolving regulatory environment. Leadership responsibility for developing regulatory capability and strengthening organizational effectiveness. What Success Looks Like In this role, you will: Lead and shape regulatory strategies that enable business growth, innovation, market access, and business continuity. Proactively connect regulatory strategies and priorities to business objectives, commercial targets, and critical deliverables, ensuring regulatory plans directly support the business in achieving its goals. Anticipate, influence, and shape the regulatory environment, positioning the business proactively rather than simply responding to requirements. Provide authoritative, strategic regulatory counsel on complex, high-impact, and potentially precedent-setting business decisions. Deliver timely and sustainable regulatory outcomes that support agreed business targets while maintaining strong compliance across the portfolio. Identify and escalate regulatory risks, issues, and potential delays early and transparently, ensuring timely visibility, clear mitigation plans, and no surprises for business leaders and key stakeholders. Build trusted influence and credibility with health authorities, industry associations, senior business leaders, and cross-functional stakeholders. Anticipate emerging regulatory risks and opportunities and translate them into clear strategic choices, mitigation plans, and business actions. Raise the strategic capability of Regulatory Affairs through coaching, knowledge sharing, and continuous improvement. Demonstrate strong ownership, independent judgment, and leadership in navigating complex regulatory matters while aligning local priorities with regional and global strategies. Key Responsibilities Regulatory Strategy & Market Access Own and lead comprehensive regulatory strategies for the local Personal Healthcare portfolio, covering new product development, registrations, variations, renewals, line extensions, business continuity, and commercialization. Provide expert-level interpretation and strategic application of local regulations across relevant product categories, including OTC drugs, health supplements, quasi-medicines, home remedies, food products, and other applicable categories. Translate complex, ambiguous, or evolving regulatory requirements into clear strategic recommendations, risk-based options, and actionable business plans. Anticipate emerging regulatory requirements and assess their implications for innovation, portfolio strategy, supply continuity, claims, labeling, and commercial plans. Challenge conventional approaches and identify creative regulatory pathways that enable innovation while maintaining compliance and protecting consumers. Act as the senior regulatory advisor to business leaders and cross-functional teams on high-impact regulatory decisions. Align local regulatory strategies with regional and global strategies while ensuring they are fit for the local regulatory and business environment. Product Lifecycle Management & Compliance Lead and oversee regulatory submissions and lifecycle activities, including new registrations, variations, renewals, post-approval changes, line extensions, and discontinuations. Provide strategic oversight of dossier development, regulatory correspondence, submission quality, approval timelines, and post-approval commitments. Lead resolution of complex or precedent-setting regulatory issues and ensure appropriate escalation and decision-making. Ensure continued compliance of the marketed portfolio with applicable regulatory requirements. Provide authoritative regulatory guidance on product classification, ingredients, formulations, labelling, artwork, packaging, and other compliance requirements. Establish proactive risk management approaches to identify, assess, mitigate, and communicate regulatory risks across the portfolio. Ensure regulatory documentation, records, and systems are maintained to the required standards. Artwork, Labelling & Promotional Compliance Provide expert regulatory leadership on artwork, labeling, packaging, claims, advertising, and promotional materials. Establish clear regulatory positions for complex or potentially contentious claims and communication requirements. Partner with Marketing, Medical, Quality, Legal, Supply Chain, and Commercial teams to develop compliant solutions without unnecessarily constraining business objectives. Resolve complex compliance issues and provide clear recommendations to enable timely commercialization. Build organizational understanding of local regulatory requirements and emerging compliance expectations. Regulatory Intelligence & External Engagement Maintain deep and current knowledge of the local regulatory landscape and relevant regional and international developments. Lead assessment of regulatory changes and translate their potential impact into portfolio-level strategies, priorities, and action plans. Establish and maintain trusted, credible relationships with health authorities, industry associations, scientific organizations, and other relevant external stakeholders. Represent P&G in regulatory discussions and external forums with confidence, credibility, and sound scientific and regulatory judgment. Lead regulatory advocacy on priority issues, influencing regulatory implementation, standards, enforcement approaches, and future policy development in support of science-based regulation and responsible industry practices. Build coalitions and effectively influence external stakeholders where regulatory changes have significant implications for the business or broader industry. Collaborate with regional and global Regulatory Affairs teams to align external engagement and advocacy priorities. Leadership & Organizational Capability Provide regul