Senior Regulatory Affairs

Adventa Healthcare Sdn Bhd; Petaling Jaya; On-site; MYR 180,000 - 300,000; Full time

Benefits offered by this job

Remuneration package

Training opportunities

Flexible work arrangements

Wellbeing programmes

Equal opportunity employer

Job summary

Adventa Healthcare Sdn Bhd in Malaysia invites an experienced Senior Regulatory Affairs professional to lead regulatory initiatives for pharmaceuticals and medical devices. Based at our Petaling Jaya office, you will coordinate submissions, liaise with regulators, and guide cross-functional teams to maintain compliance across product lifecycles.

Your scope includes preparing registration dossiers, ensuring GMP/GRP compliance, managing post-market surveillance, and mentoring junior staff while

Qualifications

• 8+ years of professional experience in regulatory affairs within pharma/medical devices.
• In-depth knowledge of Malaysian regulatory requirements (MDA, NPRA).
• Experience preparing and managing regulatory submissions and dossiers.
• Strong understanding of GMP, GRP, and QMS concepts.

Responsibilities

• Coordinate regulatory processes including registrations, renewals, and audits.
• Prepare and submit regulatory documentation to MDA, NPRA, and overseas authorities.
• Ensure compliance with ISO 13485, ISO 14971, GDP, MDD/MDR where applicable.
• Lead regulatory strategies for product submissions and lifecycle management.
• Mentor junior regulatory staff and maintain regulatory intelligence.

Skills

Regulatory affairs

Regulatory submissions

Quality systems

Leadership

Cross-functional collaboration

English communication

Education

Bachelor's in pharmaceutical sciences

Advanced regulatory affairs certification

Job description

About us

Adventa Healthcare Sdn Bhd is a leading organisation in the pharmaceuticals and medical devices sector, dedicated to delivering innovative healthcare solutions that improve patient outcomes. We are committed to maintaining the highest standards of regulatory compliance, quality, and excellence across all our operations. Our team comprises passionate professionals who are driven by a shared mission to advance healthcare and make a meaningful impact on the lives of those we serve.

About the role

We are seeking a Senior Regulatory Affairs professional to join our dynamic team at our office in Petaling Jaya, Selangor on a full-time basis. In this strategic role, you will be responsible for leading regulatory affairs initiatives and ensuring compliance with all relevant pharmaceutical and medical device regulations. You will serve as a key liaison between our internal teams and regulatory authorities, playing a vital role in bringing our products to market whilst maintaining the highest regulatory standards. This position is integral to our company's success and growth trajectory in the pharmaceuticals and medical devices sector.

Key responsibilities

• Coordinate and maintain regulatory processes, including inspections, internal audits, licence renewals and product registrations
• Prepare, compile and submit regulatory documentation to MDA, NPRA and relevant overseas regulatory authorities
• Ensure compliance with applicable regulations and standards, including ISO 13485, ISO 14971, GDPMD, GDP and MDD/MDR
• Review procedures and reports to identify non-conformities and regulatory risks
• Support and maintain an effective Quality Management System (QMS)
• Liaise with Product Development and other departments on regulatory requirements, product development, labelling and regulatory changes.
• Develop and implement comprehensive regulatory strategies for product submissions, including registration dossiers and technical documentation
• Manage and track the registration status of marketed products and regulatory activities
• Lead interactions and communications with regulatory authorities such as the Malaysian Medical Device Authority and pharmaceutical regulatory bodies
• Oversee the preparation, review, and submission of regulatory documents and applications to ensure accuracy and compliance
• Monitor changes in pharmaceutical and medical device regulations and provide guidance to internal teams on compliance requirements
• Ensure products meet all applicable quality, safety, and efficacy standards throughout their lifecycle
• Manage post-market surveillance activities and adverse event reporting procedures
• Collaborate with cross-functional teams including quality assurance, clinical affairs, and commercial teams to support product development and commercialisation
• Mentor and supervise junior regulatory staff, fostering their professional development and ensuring consistency in regulatory practices
• Maintain detailed regulatory intelligence and documentation systems for audit trail purposes
• Represent the company in regulatory meetings and inspections by competent authorities
• Participate as a member of the internal audit team and support relevant training and meetings.
• Liaise with regulatory authorities, suppliers and relevant stakeholders
• Perform other duties as assigned by management

What we’re looking for

• 8+ years of professional experience in regulatory affairs within the pharmaceuticals and/or medical devices industry
• In-depth knowledge of Malaysian regulatory requirements for pharmaceutical and medical device products, including those set by the Malaysian Medical Device Authority
• Proven expertise in preparing and managing regulatory submissions, including product registrations and technical dossiers
• Strong understanding of quality management systems, good manufacturing practices (GMP), and good regulatory practices (GRP)
• Experience with post-market surveillance, pharmacovigilance, and adverse event reporting
• Excellent written and verbal communication skills in English; proficiency in Malay is advantageous
• Advanced knowledge of relevant regional and international regulatory frameworks
• Demonstrated ability to manage multiple projects simultaneously whilst maintaining attention to detail
• Strong leadership and interpersonal skills with the ability to work effectively across departments
• Bachelor's degree in pharmaceutical sciences, life sciences, healthcare, or a related discipline; an advanced qualification or certification in regulatory affairs is preferred

What we offer

At Adventa Healthcare Sdn Bhd, we are committed to creating a supportive and rewarding work environment where our employees can thrive. We offer competitive remuneration packages commensurate with experience and qualifications. We provide opportunities for continuous professional development, including training in regulatory updates and industry certifications. Our workplace culture fosters collaboration, innovation, and mutual respect. We believe in maintaining a healthy work-life balance and offer flexible working arrangements where possible. Employees benefit from a comprehensive range of benefits and wellness programmes designed to support their physical and mental wellbeing. We are an equal opportunities employer and welcome applications from all qualified candidates.