Head of Regulatory Affairs Indonesia

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you’ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.

**About the Role**:
Strategic direction and management of the Regulatory Affairs business unit to provide regulatory services and initiatives in support of Indonesia’s business objectives while maintaining the Company's Healthcare profile as a recognized, ethical, and responsible, research-based biopharmaceutical leader within its therapeutic areas in Indonesia. The role is a part of the leadership team for Healthcare in Indonesia and is the seniormost representative for regulatory matters, driving internal and external stakeholder management, advocacy, and representing the company in industry forums.
- Deep understanding of the regulatory ecosystem for healthcare business in Indonesia, advising the country MD on regulatory topics
- Build and represent the company externally with key government and industry stakeholders
- Responsibility for Indonesia’s filing strategy to maximize business outcomes.
- Lead proactively all regulatory file submissions, comply with Indonesia’s regulations and internal processes, and train regional hub members appropriately.
- Provide senior management and Country Leadership Team with an assessment of the impact of new and changing regulations in Indonesia and the global regulatory environments on the local business, including potential risks and mitigation strategies.
- Review and recommend policies, objectives, and plans to ensure that data related to a drug under development will fulfill the needs of regulatory authorities, thereby assuring prompt approval and launch.
- Develop required regulatory standards and standard operating procedures.
- Ensure all licenses and regulatory compliance topics are properly monitored and up to date to enable smooth operations for the Healthcare business in Indonesia.
- Drive the strategic direction of the Regulatory Affairs business unit to support the company's business objectives in a timely, effective, ethical, and professional manner.
- Represent the business Healthcare Indonesia's local Regulatory business unit with relevant global functions and stakeholders.
- Ensure all activities of the company are consistent with current medical and scientific knowledge, industry and regulatory guidelines, as well as the corporate standards relevant to regulatory and quality activities and ethical behaviour.
- Together with Global and the Managing Director - Indonesia, and in collaboration with the Business Units, ensure that adequate resources, structure, and processes are in place to ensure achievement of the company's Indonesia business objectives.
- Provide leadership, coaching, and support for both direct and indirect reports, especially for the regional Regulatory hub ensuring the respective teams/functions support Healthcare Indonesia business objectives.
- Provide regulatory and quality expertise at cross-functional project team meetings
- Ability to build strong internal networks and position oneself as an expert with cross-functional peers
- Support, lead, coach, motivate, and performance manage the team for career development
- Provide financial resources planning estimates for the department in the annual budgeting process
- Develop and implement the overall business plan for the business unit once approved
- Conduct financial analysis and reporting relevant to the business unit and provide information to Global and the Managing Director
- Report to the Regional/Global & Managing Director as required
- Maintain regular communication between business units and other internal customers

**Who you are**:

- Advanced degree in a relevant field (e.g., Pharmacy, Life Sciences, Regulatory Affairs, or related disciplines).
- Significant experience in regulatory affairs within the biopharmaceutical or healthcare industry, with a deep understanding of the regulatory ecosystem in Indonesia.
- Proven track record in managing regulatory submissions and compliance processes.
- Experience in a leader