Regulatory Affairs, Senior Manager

About the job

Morgan Philips Group has partnered with a global biopharmaceutical organization dedicated to advancing medical innovation and expanding patient access to critical therapies. We are seeking a high-caliber Regulatory Affairs, Senior Manager to serve as the leading regulatory authority for the local affiliate. You will be responsible for navigating the complex legislative landscape, steering a high-performing team to accelerate product launches and ensure the highest standards of pharmaceutical governance.

What You'll Do (Key Responsibilities)

• Architect Regulatory Strategy: Develop and lead innovative, risk-based filing strategies that expedite patient access to the product pipeline while influencing global regulatory frameworks.

• Operational Excellence: Oversee the end-to-end regulatory lifecycle, ensuring seamless integration of local registration requirements with global commercial objectives and supply continuity.

• Drive Launch & Compliance Success: Lead the launch readiness plans and maintain total oversight of affiliate compliance, ensuring the organization is perpetually prepared for Health Authority audits and inspections.

• Cultivate Human Capital: Act as a strategic mentor and coach for the regulatory team, managing resource allocation, talent acquisition, and professional development to build a future-ready workforce.

• Strengthen Stakeholder Partnerships: Serve as the primary liaison with the Ministry of Health (MOH) and industry associations, actively shaping policy and advocating for solutions to unmet medical needs.

What You'll Bring (Requirements)

• Education: A Degree in Pharmacy, accredited by the relevant Malaysian authorities, is mandatory; must be eligible to hold all necessary pharmaceutical and poison licenses.

• Experience: Minimum 5–10 years of progressive leadership within Regulatory Affairs, specifically within a multinational pharmaceutical environment.

• Business Acumen: A strategic mindset with the ability to translate complex regulatory intelligence into actionable business insights that support market access and commercial growth.

• Soft Skills: Exceptional negotiation and communication skills, with a proven ability to influence senior global stakeholders and lead cross-functional team through complex regulatory hurdles.

What's Next
If this sounds interesting, please apply soonest and we will reach out.

Morgan Philips is compliant to PDPA laws, and all applications are strictly confidential. Do note that once your profile is submitted to Morgan Philips, we may be in touch for other potential positions which fit you.