Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

We are seeking a highly experienced and dynamic Regulatory Affairs Director, APAC, for our Clinical Research Group (CRG) (legacy PPD) based in South Korea. This individual contributor role is pivotal in driving regulatory strategies and ensuring compliance across the Asia-Pacific (APAC) region supporting our mission to enable life-changing therapies through clinical research excellence. The ideal candidate will have experience working for an Asia regulatory authority and possess a deep understanding of regulatory requirements in clinical research area across multiple countries in Asia.

Key Responsibilities:

Regional Leadership: Provide functional leadership and regulatory support across the APAC region, connecting with senior regulatory leaders to ensure cohesive strategies and compliance.Regulatory Expertise: Interpret and communicate country-specific regulatory requirements, particularly for legal representative roles, to mitigate risks of reputational damage, fines, and penalties.Proactive Communication: Continuously scan for regulatory changes and proactively communicate their impact to the wider business, including roles such as Importer of Record, legal representatives, and local applicants.Customer Engagement: Participate in customer meetings, proposals, bid defenses, and local conferences to showcase our clinical research capabilities in the APAC region. Build and maintain strong relationships with customers to instill confidence in our global regulatory capabilities.Cross-Functional Leadership: Represent regulatory as a prominent figure on the regional cross-functional leadership team, and linking with the global regulatory affairs leadership, partnering with other Clinical Research Group (CRG) regional leaders to propel central initiatives.Industry Insight: Leverage industry data indicating continual growth in clinical research across APAC compared to the flat volume in the EU, to inform and guide regulatory strategies and business decisions.

Qualifications:

Extensive experience working at an Asia regulatory authority.Proven track record of regulatory affairs experience across multiple countries in Asia.Strong understanding of APAC regulatory requirements and legal representative roles.Exceptional communication and leadership skills.Ability to proactively identify and communicate regulatory changes and their business impact.Experience in customer engagement and building confidence in regulatory capabilities.Ability to work independently and as part of a cross-functional leadership team.Report into the global regulatory function and contribute to the overall running of the regulatory affairs function