Deskripsi Pekerjaan
We are seeking a highly skilled and strategic Regulatory Affairs Manager to oversee our organization's regulatory standing across all key markets. In this pivotal role, you will be the primary point of contact for health authorities, ensuring that all product authorizations, labeling requirements, and compliance standards are meticulously met.
The successful candidate will demonstrate a deep understanding of the local and international regulatory landscape, providing technical guidance to cross-functional teams to ensure seamless product lifecycles. You will be responsible for interpreting complex regulations and implementing robust internal policies that mitigate risk while facilitating market access. If you are a proactive leader with a track record of excellence in regulatory strategy and submission management, we invite you to join our dynamic healthcare team in Petaling Jaya.
Tanggung Jawab
- Lead and manage regulatory submission strategies for new product registrations and renewals.
- Ensure full compliance with local health authority regulations and international quality standards.
- Coordinate with internal departments (R&D, QA, Marketing) to ensure product labeling and promotional materials meet regulatory requirements.
- Monitor and analyze changes in the regulatory environment, providing actionable insights to leadership.
- Act as the primary liaison between the organization and external regulatory agencies.
- Develop and maintain internal regulatory SOPs and documentation systems.
- Manage post-market surveillance activities and report adverse events as required by local law.
Kualifikasi
- Bachelor’s Degree in Pharmacy, Life Sciences, Chemistry, or a related healthcare discipline.
- Minimum of 5-8 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
- In-depth knowledge of NPRA (National Pharmaceutical Regulatory Agency) guidelines and ASEAN regulatory requirements.
- Proven ability to manage complex registration dossiers and effectively communicate with government officials.
- Strong analytical, organizational, and technical writing skills.
- Demonstrated leadership capabilities with the ability to influence cross-functional teams.
- High level of proficiency in English and Bahasa Malaysia for effective documentation and reporting.