Manager Regulatory Affairs

1 week ago

Petaling Jaya, Malaysia DKSH Full time

**Location**:Petaling Jaya, MY, MY**Job Function**:Client and Customer Services**Requisition Number**:149489**Description**:
**Job Summary**
- **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 couch coaching mentoring to other Regulatory Affairs personnel.**

**General Responsibilities**

**Regulatory Affairs**
- 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 not limiting to the followings:

- Maintenance of local Pharmacovigilance System (PSMF)
- Prepare and maintain the standard operating procedures (SOPs) and other controlled quality documents
- Performing trend analyses, compliance check 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

**Functional Skills and Knowledge**
- Demonstrate strong understanding and well verse of the consumer healthcare business.
- Relevant experience in the 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 mind set and resourceful.
- Ability to understand business needs and deliver meaningful market analysis or assessment with recommendations.
- Demonstrate fluency in English, both written and spoken

**Education**
- Bachelor's Degree in Pharmacy WITH a minimum 5-6 years of relevant work experience in the Pharmaceutical industry.
- Must be a Registered Pharmacist.

**Why It’s Great to Work at DKSH**

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 everyday. Join our team where entrepreneurship meets flexible work arrangements. Take the leap and start a journey where you can grow and make a difference

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