ASEA Geo Expansion Regulatory Manager

• 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.

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: to bring health in people’s hands by making self-care as simple as it should be for over half a billion consumers worldwide.

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 four 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 to bring health in your hands at www.opella.com.

Mission & Tasks

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.

Requirements:

• 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.

Why us?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers