Senior Manager – Regional Head, Regulatory APAC

About the Role

In this Senior Manager and Regional Head position for Regulatory APAC, you are responsible for offering high-level regulatory guidance and directing complex international, regional, and domestic initiatives. You play a central role in ensuring premium service delivery that supports the organization’s commercial goals. Your mandate includes overseeing regulatory workflows to secure and preserve marketing approvals for a broad portfolio, covering human and animal drugs, medical equipment, beauty products, nutritional supplements, and botanical items. You are also tasked with advancing regional expansion by managing client growth, handling proposals, and pursuing business development. Additionally, you will participate in defining the practice's long-term aims, while seeking ways to enhance innovation, streamline operations, and broaden service offerings. By cultivating teamwork, you will maintain functional excellence, manage staffing requirements, and serve as a primary consultant regarding team potential and scalability within the worldwide enterprise.

Requirements

• You need a university qualification in Life Sciences; a Master's degree in business or health administration is advantageous.
• A minimum of a decade of experience in Regulatory Affairs within the healthcare or drug sector is mandatory, with at least five of those years in a leadership role.
• Credentials related to regulatory affairs, clinical trials, health economics, or real-world evidence are seen as significant assets.
• You must demonstrate deep financial and business intelligence, coupled with a proven track record of managing and nurturing diverse, high-caliber teams at various levels.
• Strong capabilities in overseeing intricate projects, managing corporate transitions, and cultivating high-level executive partnerships are required.
• Fluency in English is required, along with the ability to inspire confidence, encourage an inclusive environment, and align client requirements with corporate priorities.

Responsibilities

• You will deliver strategic regulatory advice and practical assistance for reports, filing submissions, and client interactions.
• It is your duty to guide, coach, and inspire regulatory experts, while managing personnel reviews and pinpointing skill deficits to execute growth plans.
• You are accountable for overseeing staff requirements, distributing workloads, and ensuring team preparedness to satisfy regional needs.
• You will be expected to define and uphold industry standards for regulatory tasks, advocate for the use of modern technical tools, and share regulatory updates throughout the department.
• Furthermore, you will direct scientific consultation processes, oversee project records, and guarantee reliable, superior performance across every regulatory engagement.

Benefits & Perks

• The organization supports equal opportunity and operates without bias regarding hiring, professional development, salary, or advancement.
• Adjustments are available for people with disabilities throughout the hiring journey.
• Perks outside of the U.S. are customized to reflect regional industry standards and differ depending on the specific country.