Overview
AGM, Regulatory Affairs Jobs in Petaling Jaya, Selangor, Malaysia at DKSH
Title: AGM, Regulatory Affairs
Company: DKSH
Location: Petaling Jaya, Selangor, Malaysia
The Country Regulatory Affairs Lead provides strategic leadership and operational oversight across all Regulatory Affairs and Pharmacovigilance functions. The RA Lead provides people leadership to the local Regulatory Affairs and Pharmacovigilance team. This includes coaching, performance management, talent development, and fostering a high-performing, collaborative culture aligned with DKSH’s values and strategic goals. This role ensures robust regulatory strategy development, regulatory compliance and effective cross-functional collaboration to support the portfolio across its lifecycle. The RA Lead acts as the key interface between cluster and local country operations, ensuring aligned strategy and excellence in execution, while adapting to local market needs and regulatory environments. The RA Lead owns the planning, execution, and monitoring of the regulatory strategy of DKSH HEC, related to the company’s pharmaceutical products and interacts closely with other groups within the company, including the regional Commercial / BD and M&A Teams, Medical Affairs, Home Care / Patient Solutions, GRC and other related departments. The role owns the regulatory affairs scope from registration, approval to timely update of the regulatory requirements across the market.
General responsibilities
Strategic Leadership
- Define and execute country-wide regulatory strategies aligned with business goals.
- Serve as a strategic thought partner contributing to product lifecycle planning and business development strategies.
Regulatory Affairs & Pharmacovigilance Leadership
- Keep an oversight of all cluster regulatory activities related to product registrations, lifecycle management across SEA countries.
- Ensure compliance with local and international regulatory standards, including GMP, GCP, and pharmacovigilance requirements.
Talent Development & People Leadership
- Coaching RA and PV team members, build & lead high-performing teams, fostering a culture of excellence and accountability.
- Mentor and develop talent, ensuring succession planning and capability building across the cluster.
Cross-functional Collaboration
- Partner with cross-functional teams to support integrated business planning and execution.
- Influence across matrixed organizations to align RA & PV priorities with commercial objectives.
- Support business development efforts by providing strategic regulatory insights that enable informed decision-making and partnership opportunities.
Governance & Compliance
- Implement and maintain robust quality systems and regulatory governance frameworks in alignment with the GRC team.
- Monitor regulatory intelligence and proactively adapt strategies to evolving policies and market dynamics.
External Engagement
- Represent the company in industry associations, regulatory forums, and scientific discussions to shape the external environment.
- Engage in client-facing activities to support business development and strategic partnerships.
- Maintain strong relationships with regulators and external partners.
Leadership responsibilities
- Leading a team of ~10 members (Regulatory and Pharmacovigilance)
Job requirements
Functional skills and knowledge
- Leads with integrity, empathy, and a strong sense of purpose
- Strategic Thinking & Enterprise Leadership with a proven ability to align regulatory strategies with broader business goals.
- Strong foundation in science and regulatory affairs with a track record of compliance and innovation
- Deep understanding of market dynamics and external healthcare environments
- Skilled at navigating complex structures and influencing cross-functional stakeholders
- Exceptional ability to communicate complex ideas clearly and build strong relationships
- Demonstrated agility to lead through change and working across diverse cultural contexts
- Committed to growing talent and building future-ready teams
- Deeply attuned to customer needs and market dynamics, with a strong focus on driving sustainable business success
- Strong leadership and talent development capabilities, committed to inspiring, coaching, and recognising high-performing teams.
