Regulatory Affairs & Quality Assurance Manager (Pharmaceuticals)

EP Plus Group; Kuala Lumpur; On-site; MYR 180,000 - 240,000; Full time

Job summary

EP Plus Group is seeking a functional lead in regulatory affairs to guide cosmetics, pharmaceutical, and medical device regulatory compliance across markets and support timely product launches according to the marketing plan.

You will lead the RA team, maintain QMS, ensure GMP/GDP/ISO compliance, liaise with NPRA and MOH, and act as QPPV/ Deputy QPPV as required, shaping strategy and safeguarding product quality.

Qualifications

• Bachelor’s Degree in Pharmacy or Science related discipline.
• Knowledge of Malaysian pharmaceutical regulations, including NPRA requirements and other relevant international regulatory guideline.
• Good understanding of GMP, GDP, ISO standard.
• Familiarity with pharmacovigilance.

Responsibilities

• Develop regulatory strategies and submission plans of new products and expansion into new territories.
• Advise management on regulatory and legislative requirements and manage third-party regulatory service providers.
• Coordinate with stakeholders to address regulatory changes while ensuring minimal disruption to stock supply.
• Develop, monitor and improve SOPs related to regulatory and quality processes.
• Ensure QMS (GDPMD, GDPMDS, GDP, PV System, ISO 9001) are effective and compliant.
• Ensure Quality and Safety agreements are in place (Quality Agreements, Pharmacovigilance Agreements).
• Lead, coach and manage RA team with training and guidance.
• Establish and Maintain rapport with regulatory agencies and health authorities.
• Represent the company in external focus groups and uphold the company image in the industry.
• Act as Qualified Person Responsible for Pharmacovigilance (QPPV)/ Deputy QPPV.

Skills

Registration of cosmetics

Pharmaceutical registration

Medical devices registration

Leadership & coaching

Stakeholder management

Communication skills

Education

Bachelor’s Degree in Pharmacy or Science

Job description

Act as a functional lead in the department / an advisor for EP Plus Group of Companies (in all countries) on cosmetics, pharmaceutical and medical device regulatory matters to ensure compliance with regulatory and legislative requirements to ensure timely and smooth product launches according to the marketing plan. To also ensure products released are according to their approved specifications, with uncompromised quality.

KEY ACCOUNTABILITIES

• Develop regulatory strategies and submission plans of new products, including expansion of existing product portfolio into new territories (ensure timely and smooth product launches according to marketing plans).
• Act as an advisor to company management on regulatory and legislative requirements of new territories and if necessary, to manage third-party regulatory service providers to ensure services rendered are as agreed according to existing agreements in place.
• Keep abreast with new or changing regulations and coordinate with internal and external stakeholders to develop strategies to address changes in product/ operations/ testing requirements, while ensuring minimal or no disruption to stock supply.
• Develop, monitor, and improve Standard Operation Procedures (SOPs) related to regulatory and quality processes, ensuring adherence to latest regulatory, legislative, and quality standards set.
• Ensure established company Quality Management Systems (QMS - GDPMD/ GDPMDS/ GDP/ PV System/ ISO 9001) are effective and comply with the latest local and international standards/ requirements, including passing audits and inspections programs.
• Ensure Quality Agreements and Safety Data Exchange Agreement/ Pharmacovigilance Agreement are in-place with the right parties.
• Manage departmental operations including departmental structure review, allocation of resources and workload to ensure project/ department milestones/ goals are met while adhering to approved thoughts.
• Lead, coach and manage the RA team with the necessary training and guidance to enable them to carry out their roles and responsibilities and ensure a smooth day-to-day operation.
• Establish and maintain rapport with regulatory agencies, Health Authorities and other related stakeholders to ensure constant and strategic engagements to advance the business agenda of the company.
• Serve as the company representative or local point in external focus groups and to upload company's image and brand in the industry.
• Act as Qualified Person Responsible for Pharmacovigilance (QPPV)/ Deputy QPPV for the company.

KNOWLEDGE, SKILLS & EXPERIENCE

Knowledge:

• Possess a Bachelor’s Degree in Pharmacy or Science related discipline.
• Knowledge of Malaysian pharmaceutical regulations, including NPRA requirements and other relevant international regulatory guideline.
• Good understanding of GMP, GDP, ISO standard.
• Familiarity with pharmacovigilance

Skills:

• Registration of cosmetics/ pharmaceutical/ medical devices/ combination product.
• Renewal of relevant company licenses
• Complaint handling and change control
• Excellent communication and stakeholder management skills
• Leadership, coaching, and team development

Experience:

• Minimum 5–8 years of experience in Regulatory Affairs and Quality Assurance within the pharmaceutical/medical devices industry.
• Minimum 2–3 years in a supervisory or managerial role leading an RA/QA team.
• Experience liaising with NPRA, Ministry of Health (MOH), and other regulatory authorities.
• Experience implementing and maintaining Management Systems.
• Experience supporting new product launches and regulatory strategies.