Title:  Senior Manager Regulatory Affairs Own Brands

About The Role

The Senior Manager, Regulatory Affairs (Own Brand) is a pivotal leadership role within DKSH's Healthcare Business Unit, driving the timely and compliant registration of healthcare products across the Asia Pacific region to support the growth and expansion of the Own Brands portfolio. This role shapes regional regulatory strategy, safeguards compliance integrity, and directly enables DKSH's in-licensing, acquisition, and product lifecycle management ambitions across multiple markets.

What You Will Deliver

• Ensure the timely registration of new chemical entities, new dosage forms, and new indications across Asia Pacific, directly supporting Own Brands commercial growth and portfolio expansion.
• Develop and implement regional registration strategies aligned with global commercial objectives, enabling in-licensing, acquisition, and lifecycle management opportunities.
• Lead and provide direction in regulatory due diligence and evaluation for in-licensing, acquisitions, and new product opportunities, ensuring sound regulatory risk assessment and informed decision-making.
• Oversee dossier preparation, review, and submission for new product registrations, variations, renewals, and line extensions, maintaining high standards of quality and regulatory compliance.
• Establish and maintain ongoing liaison with relevant regulatory authorities and market Regulatory Affairs (RA) teams to monitor, assess, and proactively respond to significant regulatory developments.
• Ensure timely communication of regulatory developments and their potential business impact to Senior Management, enabling informed and proactive organizational decisions.
• Maintain the integrity and accuracy of the Regulatory Affairs database, including master dossiers, registration status, and regulatory requirements across all markets in scope.
• Monitor and ensure the registration lifecycle of existing products, including drugs, medical devices, food supplements, and cosmetics, remains current and fully compliant.
• Serve as the primary liaison with market Regulatory Affairs teams on all Own Brands regulatory matters, providing guidance and direction on product registrations and related regulatory activities.
• Collaborate effectively with cross-functional teams including Research and Development (R&D), Medical Affairs, Quality Assurance (QA), Supply Chain Management (SCM), and Commercial teams to ensure successful and compliant product launches.
• Drive and manage the performance of the Regulatory Affairs team across Own Brands and market RA teams, building functional capabilities and a high-performing regulatory community.
• Administrative duties and coordination tasks as required.

What You Bring

• Bachelor's degree in Pharmaceutical Sciences, Life Sciences, or a related field; an advanced degree or Regulatory Affairs Certification is preferred.
• Minimum 8 years of Regulatory Affairs experience in the pharmaceutical industry and related healthcare products, with at least 3 years in a managerial role leading a team.
• Regional or multi-market Regulatory Affairs experience is strongly preferred.
• Good knowledge of regulatory requirements and compliance standards for healthcare products across multiple categories.
• Proven experience registering new chemical entities and new drugs, including regulatory submissions such as Investigational New Drug (IND) applications and marketing applications in Common Technical Document (CTD) format.
• Sound understanding of ASEAN harmonization of healthcare product registration.
• Solid understanding of Food and Drug Administration (FDA), European Medicines Agency (EMA), and Therapeutic Goods Administration (TGA) regulations and International Council for Harmonisation (ICH) guidance.
• Knowledge and familiarity with the National Medical Products Administration (NMPA) and other global regulatory agencies are preferred.
• Proven ability to manage complex regulatory projects independently across multiple markets.
• Strong written and spoken English communication skills, with the ability to influence cross-functional stakeholders across diverse markets.
• Proficient in office productivity tools including Excel, Word, and PowerPoint.

Why Join DKSH

At DKSH, we help companies grow in Asia and enable people to perform at their best. You will be part of an organization that values accountability, collaboration, and long-term partnerships. We offer a dynamic environment where your contributions are visible and where you can build a meaningful career in Regulatory Affairs.

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