Manager Regulatory Affairs

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Responsibilities

• Responsible for providing regulatory expertise to Business Unit Healthcare, DKSH Malaysia Sdn Bhd, and for ensuring the company’s Pharmaceutical and Medical Device operations are in compliance with the requirements of the local Regulatory Authorities.
• Leading a subunit providing coaching and mentoring to other Regulatory Affairs personnel.
• Supporting the Regulatory Affairs team in submitting regulatory applications (submission, renewal, and variation) and obtaining timely approvals from the Regulatory Authorities.
• Liaise with local Regulatory Authorities to expedite early regulatory approvals while developing and pursuing excellent working relationships.
• Identify, develop, and establish contact with new/potential/existing business partners in line with Company business development strategy and prioritizing business opportunities. Manage profit and loss by planning resources versus income.
• Ensure services rendered to clients are in accordance with Regulatory Agreements.
• Provide support, training, and advice to internal Business Unit Healthcare teams (SMOTC, SMPH, CMP, CMMD, BD, QA, Warehouses, etc.).

Pharmacovigilance (PV)

Responsible for instituting and maintaining the key aspects of Pharmacovigilance/Vigilance Management which consist of but are not limited to the following:

• Maintenance of local Pharmacovigilance System (PSMF).
• Prepare and maintain the standard operating procedures (SOPs) and other controlled quality documents.
• Perform trend analyses, compliance checks, and predictive modeling for compliance operations.
• Participate in Inspection/Audit, development of corrective action plans, and Corrective and Preventative Action (CAPA) implementation.

Registered Pharmacist

Responsible for supervising the discharge of psychotropic drugs.

• Demonstrate strong understanding and well-versed in the consumer healthcare business.
• Relevant experience in Regulatory Affairs, especially in the Pharmaceutical industry.
• Proficiencies in Microsoft Excel.
• Ability to work in a team with attention to detail and able to work under pressure.
• Entrepreneurial mindset and resourceful.
• Ability to understand business needs and deliver meaningful market analysis or assessment with recommendations.
• Demonstrate fluency in English, both written and spoken.
• Bachelor's Degree in Pharmacy WITH a minimum of 5-6 years of relevant work experience in the Pharmaceutical industry.
• Must be a Registered Pharmacist.

At DKSH, we are driven by a purpose that goes beyond the ordinary: enriching people's lives. Through the products and services we provide, DKSH positively impacts millions of lives every day. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference!