Regulatory Affairs Lead - Healthcare MNC

Michael Page

Kuala Lumpur
RM 84,000-108,000 per year
Permanent
Full-time

29 days ago
Apply easily

The team lead will be ensuring compliance with regulatory requirements governing renal healthcare services. Responsibilities include developing and implementing regulatory strategies, policies and procedures to maintain adherence to local and international standards. This person will also oversee the preparation and submission of documents and applications including licenses and certifications while collaborating with cross functional departments.

Develop and implement regulatory strategies and policies to ensure compliance with local (MOH and CKAPS) standards.
Oversee the preparation and submission of regulatory documents and applications, including licensing and certifications for the centres.
Ensure the medical centres are accredited in accordance to MSQH.
Stay informed about regulatory updates and changes, providing guidance to internal stakeholders on compliance requirements.
Collaborate cross-functionally with various departments to support business objectives while upholding regulatory integrity.
Lead regulatory affairs team, providing direction, mentorship, and support to team members.
Provides coaching and leadership to teammates.
Participates in operations reviews, reports and resource allocation.
Develops a collaborative team environment.

Leadership management opportunity in the country |Strong exposure to collaborate closely multiple stakeholders

Study background: Bachelor's degree or professional qualification, preferably with major in Life Science, Pharmacy, Biotechnology or a related technical field.
An established candidate with a minimum of 5 years' experience in the healthcare regulatory affairs sector with strong track records, registrations and life cycle management.
Have people management and good leadership skills.
Outstanding strategic planning with the ability to develop actionable solutions and recommend strategies.
Exceptional effective interpersonal relationship & communication skills with both internal and external stakeholders
Have fluent oral and written communication skills in English.
Ability to travel within Malaysia, with a focus on Central region.

Our client is a healthcare MNC which specialises in healthcare services, offering comprehensive treatments like hemodialysis and peritoneal dialysis. They prioritise patient-centric care with personalised treatment plans. The organization's multidisciplinary team of healthcare professionals is committed to delivering high-quality renal care services and emphasising ongoing support for patients. With a focus on innovation, education, and community engagement, it aims to significantly impact kidney health in Malaysia's healthcare landscape.

Patient-Centric Approach: Prioritises patient care and well-being, offering an opportunity to work in a company dedicated to providing high-quality renal care services.
Professional Growth and Development: Emphasises continuous learning and skill enhancement, with access to training programs, development opportunities, and a supportive environment.
Innovation and Impact: Committed to innovation and making a difference in the healthcare landscape.

Michael Page