Global Regulatory Affairs Lead — Submissions & Lifecycle

BIG Pharmacy Healthcare Sdn Bhd; Klang City; Vor Ort; MYR 180.000 - 300.000; Vollzeit

Zusammenfassung

BIG Pharmacy Healthcare Sdn Bhd seeks an experienced Regulatory Affairs leader to oversee product registrations from Bukit Raja Klang. You will manage submissions, liaise with national authorities, and guide cross-functional teams on GDP, GDPMD, ISO 13485 and related standards while driving portfolio expansion to new markets.

Your role requires a decade in pharma regulatory affairs, strong stakeholder skills, and a strategic mindset to ensure compliant, timely registrations across regions.

Qualifikationen

• Bachelor's Degree in Pharmacy (preferred) or degree in Science/Nutrition or related field.
• At least 10 years of experience in the pharmaceutical industry, specifically in Regulatory Affairs.
• Proven track record of successful product registrations, regulatory submissions, and lifecycle management.
• Strong knowledge of national and international regulatory guidelines and standards.
• Excellent communication and interpersonal skills, with the ability to work effectively with regulatory authorities and internal teams.
• High attention to detail, with strong analytical and problem-solving abilities.
• Ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.

Aufgaben

• Oversee and manage the entire process of product registration, ensuring compliance with regulatory requirements and timely submissions local and overseas.
• Plan, coordinate, and execute Regulatory Affairs activities within the designated region, ensuring alignment with company objectives and regulatory standards.
• Manage the full regulatory lifecycle of products, including submissions, approvals, variations, renewals, and ongoing maintenance with the national regulatory authorities.
• Conduct feasibility assessments of new products for importation, ensuring alignment with national regulations and market entry strategies.
• Gather, prepare, and review all necessary data for product registration, ensuring that submissions meet the required standards for regulatory acceptance.
• Serve as the primary point of contact with national regulatory authorities, developing and presenting strategies for new product submissions and portfolio maintenance.
• Foster and maintain strong professional relationships with regulatory bodies to ensure smooth communication and negotiation on regulatory matters.
• Stay updated on regulatory changes and trends, providing strategic input on how they may impact current and future product registrations.
• Provide cross-functional support to internal teams, including Business Development, marketing, sales, and R&D, to ensure regulatory compliance is integrated into product development and commercialization processes.
• Plan and execute departmental KPIs, regulatory project trackers, submission dashboards, issue logs, and portfolio monitoring mechanisms to ensure visibility of regulatory progress and risks.
• Participate in regulatory authority inspections, internal audits, supplier audits, principal audits, and support for GDP, GDPMD, ISO 13485 and other applicable quality management systems, according to the company's licensed activities and risk assessments, CAPA, change controls, deviation management, complaints, and recall procedures.
• Responsible for Internal Regulatory Compliance, Regulatory Affairs (MAL, MDA, NOT, Halal, KKLIU, Food, Wholesale License etc, Internal Regulatory Compliance.
• Responsible for the External Audit and compliance which involved the division policies and procedure
• Lead the Global Market Registration Expansion - Vietnam, Thailand, Indonesia, Philippines & Singapore.

Kenntnisse

Regulatory Affairs

Regulatory submissions

Communication skills

Attention to detail

Project management

Ausbildung

Bachelor's Degree in Pharmacy

Science/Nutrition related degree

Jobbeschreibung

BIG Pharmacy Healthcare Sdn Bhd seeks an experienced Regulatory Affairs leader to oversee product registrations from Bukit Raja Klang. You will manage submissions, liaise with national authorities, and guide cross-functional teams on GDP, GDPMD, ISO 13485 and related standards while driving portfolio expansion to new markets.

Your role requires a decade in pharma regulatory affairs, strong stakeholder skills, and a strategic mindset to ensure compliant, timely registrations across regions.