ASEA Geo Expansion Regulatory Manager

1459 Opella Healthcare Singapore Pte Ltd; Jakarta Pusat; Sur place; IDR 900 000 000 - 1 500 000 000; Plein temps

Résumé du poste

Opella Healthcare Singapore Pte Ltd seeks an ASEA Geo Expansion Regulatory Manager to drive regulatory strategy and dossier execution in Jakarta and regional hubs. You will champion innovative expansion while ensuring compliance with local regulations and company standards.

The role calls for strong leadership, project management, and cross-functional collaboration to support market entry, launches, and lifecycle management across ASEA brands.

Qualifications

• Experience leading regulatory strategy and dossiers for consumer health products.
• Strong knowledge of regulatory requirements across ASEA markets.
• Ability to manage cross-functional teams across multiple geographies.

Responsabilités

• Regulatory Strategy Execution: lead ASEA science strategy and geographic expansion.
• Project Leadership & Dossier Management: plan and execute regulatory projects with cross-functional teams.
• Portfolio Growth & Opportunity Delivery: enable market entry, product launches, and lifecycle management.
• Lifecycle Management: oversee renewals, variations, and discontinuations across affiliates.
• Compliance & Data Integrity: ensure regulatory compliance and accurate databases.
• Stakeholder Communication & Risk Management: coordinate internal/external communications and mitigation plans.
• Regulatory Intelligence & Impact Assessment: monitor regulatory changes and opportunities.

Connaissances

Leadership

Cross-functional leadership

Strategic thinking

Project management

Stakeholder management

Regulatory knowledge

Communication (English)

Matrix environment

Prioritization

Formation

Medical Doctor

Pharmacist

Pharm D

Veterinary Doctor

Health Sciences (Nursing, Dietetics, Pharmacology)

MPh or master's degree

Description du poste

Job Title: ASEA Geo Expansion Regulatory Manager Reporting to: ASEA Science Head Location: Jakarta, Indonesia Alternate Locations: Ho Chi Minh City, Vietnam or Taguig, Philippines. You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As an ASEA Geo Expansion Regulatory Manager, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human.

Job Purpose:

• Within the framework of Opella business, implement GEO Expansion strategy & Operating plan as aligned with ASEA Science Hub Head, that contributes to maximize the benefits of our products for our consumers, in compliance with local regulations and company standards
• Embedding regulatory excellence in zone regulatory strategies to drive success for Opella
• Driving transformations focused on excellence in execution, adopting innovative approaches, simplification, including optimization of processes and embracing digital as part of strategic roadmap

For assigned brand/portfolio:

• Regulatory Strategy Execution: Champion and implement the ASEA science strategy, focusing on innovation, renovations (including claims development) and geographic expansion to support business growth for assigned portfolios.
• Project Leadership & Dossier Management: Lead regulatory project planning and execution, including dossier preparation and response strategies in collaboration with cross-functional teams to meet local regulatory requirements and commercial objectives.
• Portfolio Growth & Opportunity Delivery: Identify and deliver key science opportunities that enable market entry, product launches, and lifecycle management for assigned brands.
• Lifecycle Management: Oversee regulatory maintenance activities such as renewals, variations, and discontinuations, ensuring timely and compliant execution across local affiliates.
• Compliance & Data Integrity: Ensure regulatory compliance for both development and marketed products. Maintain accurate regulatory databases and ensure timely updates based on affiliate feedback and regulatory changes.
• Stakeholder Communication & Risk Management: Coordinate communication across internal and external stakeholders. Proactively identify risks, develop mitigation plans, and ensure timely execution of regulatory activities.
• Regulatory Intelligence & Impact Assessment: Monitor regulatory changes and competitor activities. Assess potential impacts and identify opportunities aligned with brand and commercial strategies.
• Process Optimization: Drive harmonization and continuous improvement of Science processes across ASEA to enhance efficiency and effectiveness.
• Cross-Regional Collaboration: Support ad hoc regional and zone-level science projects as assigned by the ASEA SH head.

About you:

• Leadership skills; problem-solve, prioritize, take initiative and meet challenges
• Excellent written and verbal communication skills. Excellent level of speaking/writing English.
• Ability to work in a matrix environment.
• Strong interpersonal and communication skills
• Cross functional leadership
• Ability to manage multiple priorities in a fast-paced, matrixed environment.
• Strategic thinking and planning
• Strong, proven project and stakeholder management skills and cross functional collaboration
• Strong knowledge of regulatory requirements across ASEA markets.
• Education: Medical Doctor, Pharmacist, Pharm D, Veterinary Doctor, Health Sciences (Nursing, Dietetics, Pharmacology), MPh or master's degree
• Experience: Preferably with 5 or more years of experience in innovation, regulatory affairs in the consumer healthcare, OTC, personal care, food, FMCG industries
• Understanding of various functions related to innovation process
• Prior experience in managing cross- local RA teams across ASEA region and work with cross functional teams across multiple geographies
• Outcome obsessed mindset, courageous, agile and able to adapt to changing circumstances.

About Us:

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan. B Corp certified in multiple markets, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.