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ASEA Geo Expansion Regulatory Manager
Job description
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 .
Description copied from Opella's careers page. Read the full posting before you apply.
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