Deskripsi Pekerjaan
Are you an experienced regulatory professional looking to elevate your career on an international stage? Reeracoen Recruitment is seeking a Regional Regulatory Senior Specialist to oversee and drive regulatory compliance strategies across the Asia and Middle East markets (excluding China and Japan).
In this pivotal role, you will act as the primary liaison between local regulatory authorities and our internal product teams. You will be responsible for navigating complex regulatory landscapes, ensuring seamless product registration, and maintaining the highest standards of compliance for our healthcare and medical portfolios. This is an exceptional opportunity to join a fast-paced environment where your expertise directly influences regional growth and patient access to quality healthcare solutions.
We are looking for a proactive, detail-oriented specialist who thrives in cross-functional collaborations and possesses a deep understanding of regional healthcare regulations.
Tanggung Jawab
- Lead end-to-end regulatory product registration processes for medical and healthcare products across assigned Asia and Middle East territories.
- Interpret and implement local regulatory policies, ensuring full adherence to international healthcare standards and regional requirements.
- Prepare and manage high-quality technical dossiers for submission to various health authorities.
- Collaborate with cross-functional teams, including marketing, supply chain, and legal, to ensure timely product launches and lifecycle management.
- Maintain a current and comprehensive database of regulatory trends, legislative changes, and guidelines relevant to the healthcare sector.
- Conduct regulatory risk assessments and develop mitigation strategies to address potential compliance gaps.
- Act as the primary point of contact for external regulatory bodies and local consultants to resolve registration queries effectively.
Kualifikasi
- Bachelor’s degree in Pharmacy, Biomedical Science, Chemistry, or a related healthcare/scientific discipline.
- Minimum of 3-5 years of direct experience in regional regulatory affairs within the medical device or pharmaceutical industry.
- In-depth knowledge of regulatory submission processes and compliance frameworks in Asia and the Middle East.
- Strong project management skills with the ability to handle multiple priorities under tight deadlines.
- Excellent communication and stakeholder management skills, with fluency in English.
- Proven ability to interpret technical documentation and translate complex data into actionable regulatory submissions.
- Meticulous attention to detail and a high level of integrity in all regulatory reporting.