job description
Join MSN LABS PHILIPPINES Inc as a Regulatory Manager and take the lead in managing end-to-end Philippine FDA processes. This is a unique opportunity to work in a dynamic environment, ensuring compliance with regulatory standards while contributing to the growth of our healthcare and medical initiatives. Based in the vibrant locations of Canggu, Ubud, Denpasar, Jimbaran, Nusa Dua, Kuta, and Badung, you will play a pivotal role in our mission to deliver high-quality healthcare solutions.
As a Regulatory Manager, you will be responsible for overseeing regulatory submissions, maintaining compliance with local and international regulations, and liaising with regulatory authorities. Your expertise will be crucial in navigating the complex landscape of healthcare regulations, ensuring that our products meet the highest standards of safety and efficacy.
If you are a detail-oriented professional with a passion for regulatory affairs and a desire to make a meaningful impact in the healthcare industry, we invite you to apply for this exciting opportunity.
Responsibility
- Manage and oversee end-to-end Philippine FDA processes, ensuring compliance with regulatory requirements.
- Prepare and submit regulatory documentation for product registrations, renewals, and variations.
- Liaise with regulatory authorities to facilitate approvals and address any queries or concerns.
- Develop and implement regulatory strategies to support the company's business objectives.
- Monitor and interpret changes in regulatory guidelines and ensure company policies are updated accordingly.
- Collaborate with cross-functional teams, including R&D, Quality Assurance, and Marketing, to ensure regulatory compliance throughout the product lifecycle.
- Conduct regulatory risk assessments and provide recommendations to mitigate potential issues.
- Maintain accurate and up-to-date regulatory records and documentation.
Qualifications
- Bachelor's degree in Pharmacy, Life Sciences, or a related field. Advanced degree preferred.
- Minimum of 5 years of experience in regulatory affairs, preferably in the pharmaceutical or healthcare industry.
- In-depth knowledge of Philippine FDA regulations and international regulatory standards.
- Proven experience in preparing and submitting regulatory documentation.
- Strong analytical and problem-solving skills with the ability to interpret complex regulatory guidelines.
- Excellent communication and interpersonal skills to effectively liaise with regulatory authorities and internal teams.
- Detail-oriented with a high level of accuracy and attention to detail.
- Ability to work independently and manage multiple projects in a fast-paced environment.