Deskripsi Pekerjaan
Join our dynamic team at Genedrift Philippines OP Corporation as a Regulatory Affairs Specialist and play a crucial role in ensuring compliance with healthcare regulations and standards. In this position, you will be at the forefront of navigating the complex regulatory landscape, safeguarding our organization's adherence to local and international healthcare regulations.
As a Regulatory Affairs Specialist, you will have the opportunity to work closely with Health Authorities, manage critical regulatory dossiers, and contribute to the successful submission and approval of healthcare products. Your expertise will directly impact our ability to bring innovative healthcare solutions to market while maintaining the highest standards of safety and efficacy.
We offer a collaborative work environment where your analytical skills, attention to detail, and regulatory knowledge will be valued. If you are passionate about ensuring compliance and making a difference in the healthcare industry, we encourage you to apply for this rewarding position.
Tanggung Jawab
- Manage and prepare regulatory submissions for healthcare products to ensure compliance with local and international regulations
- Coordinate effectively with Health Authorities to address inquiries and ensure timely approvals
- Maintain and organize regulatory dossiers with accurate and up-to-date documentation
- Monitor and ensure adherence to all relevant regulatory requirements and industry standards
- Communicate with clients and stakeholders regarding regulatory requirements and compliance status
- Oversee project monitoring activities to ensure regulatory milestones are met
- Stay current with evolving regulatory landscapes and implement necessary changes to maintain compliance
Kualifikasi
- Bachelor's degree in Pharmacy, Medicine, Biology, Chemistry, or related field
- Minimum of 2 years of experience in regulatory affairs within the healthcare or pharmaceutical industry
- Strong knowledge of local and international healthcare regulations and standards
- Excellent communication skills with the ability to interact effectively with Health Authorities
- Attention to detail with strong organizational and documentation abilities
- Proficiency in regulatory submission processes and dossier management
- Ability to manage multiple projects simultaneously and meet deadlines
- Strong problem-solving skills and ability to interpret complex regulatory requirements