Business Development Manager (Pharma / CRO / Regulatory Affairs)

Microfield; Kuala Lumpur; On-site; MYR 100,000 - 150,000; Full time

Job summary

An international pharmaceutical-related company is seeking a Business Development Manager with experience in the Malaysian market. The role involves engaging local pharmaceutical partners, coordinating CRO projects, and supporting regulatory affairs in Malaysia. Candidates should possess a relevant degree and experience in CRO or regulatory affairs. Strong communication skills and proficiency in English and Mandarin are essential. The position offers competitive compensation and the chance to shape market entry strategies.

Benefits

Direct involvement in cross-border pharmaceutical projects

Opportunity for market entry shaping

Flat structure and high autonomy

Long-term growth in line with expansion

Competitive compensation and performance-based incentives

Qualifications

• Proven experience in CRO business development or CRO project coordination.
• Hands-on exposure to pharmaceutical regulatory affairs in Malaysia.
• Strong understanding of drug development workflows.

Responsibilities

• Build and maintain relationships with Malaysian pharmaceutical companies.
• Act as the main local liaison between Malaysian partners and international teams.
• Support drug registration activities in Malaysia.

Skills

Commercial awareness

Technical understanding

Excellent communication

Stakeholder management

Independent working

Education

Bachelor’s degree in Pharmacy, Life Sciences, Biotechnology or related field

Job description

Business Development Manager (Pharma / CRO / Regulatory Affairs)

We are an international pharmaceutical-related company focusing on API supply, drug development collaboration, and cross-border pharmaceutical projects. We are expanding our presence in Malaysia and Southeast Asia, and are seeking a locally experienced professional to support business development, CRO collaboration, and regulatory coordination with Malaysian pharmaceutical partners.

Key Responsibilities:

1. Business Development & Local Partner Engagement

• Build and maintain relationships with Malaysian pharmaceutical companies, including generic drug manufacturers, formulation plants, and CROs
• Identify and evaluate collaboration opportunities (API supply, formulation development, BE studies, clinical trials, technology transfer, etc.)
• Act as the main local liaison between Malaysian partners and China/international teams
• Support commercial negotiations, project feasibility discussions, and long-term cooperation planning

2. CRO & Project Coordination

• Assess and recommend suitable CRO partners (bioequivalence, clinical, analytical, stability studies, etc.)
• Coordinate communication between CROs, sponsors, and internal teams
• Support project timelines, milestones, and documentation flow for CRO-managed studies

3. Regulatory Affairs Support (Malaysia Focus)

• Support or coordinate drug registration activities in Malaysia (NPRA-related processes, product registration, variations, renewals)
• Assist in dossier preparation (CTD/ACTD familiarity preferred)
• Collaborate with internal teams, regulatory consultants, and local agents to ensure compliance
• Provide regulatory input during early-stage business development and project evaluation
• Monitor Malaysian pharmaceutical market trends, regulatory updates, and competitive landscape
• Provide insights on registration timelines, CRO cost structures, and local pharma expectations
• Support management in Southeast Asia expansion strategy

Qualifications & Experience:

Mandatory:

• Bachelor’s degree or above in Pharmacy, Life Sciences, Biotechnology, or related field
• Proven experience in CRO business development OR CRO project coordination
• Hands‑on exposure to pharmaceutical regulatory affairs in Malaysia
• Strong understanding of drug development workflows, CRO operations, and regulatory submission logic
• Proficient in English and Mandarin

Preferred:

• Experience with Malaysian pharmaceutical manufacturers or generic drug registration projects
• Familiarity with API-to-finished-dose collaborations and NPRA regulations
• Experience bridging China–Malaysia or international pharma collaborations
• Existing local pharma or CRO network is a strong advantage

Key Skills:

• Strong commercial awareness combined with technical understanding
• Excellent communication and stakeholder management skills
• Ability to work independently and manage multiple external partners
• Practical, execution‑oriented mindset (beyond administrative RA tasks)

Employment Type:

Full‑time / Part‑time / Consultant (negotiable)

Salary: Competitive, based on experience (to be discussed)

Benefits / Why Join Us:

• Direct involvement in cross-border pharmaceutical projects
• Opportunity to shape Malaysia & Southeast Asia market entry
• Flat structure, high autonomy, and strategic exposure
• Long‑term growth aligned with international expansion
• Competitive compensation + performance‑based incentives