Position Overview
This position requires a very high level of autonomy to support Andaman Medical in achieving regulatory goals and objectives. The Senior Regulatory Affairs Specialist is expected to drive best practices in regulatory, office and administrative management within the organization to maximize efficiency and growth. The main responsibility is to proactively support the organization in achieving the necessary regulatory submissions needed for our clients and to develop and maintain worldwide regulatory knowledge.
Essential Job Functions
Regulatory
- Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and its route of submission.
- Preparing and submitting documents related to Initial, Renewal, Variations/Change Notification of medical devices, follow-up until approval process.
- Promptly inform manufacturer is there's any feedback from Authority to ensure successful product registration.
- Communicating with customers in respond to their regulatory concerns.
- Maintain regulatory database for the Company.
- Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
- Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to Marketing Manager.
- Assist sales team in discussion with client on regulatory related matters (when required).
- Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Liaising with external parties on matters relating to Indonesia medical device regulatory requirements.
- Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
- Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.
Inter Country Operations Support Role
- Develop content of marketing materials, e.g. writing regulatory updates, web-based learning, webinars and present
- Act as Regulatory Intelligence project coordinator and reviewer of the regulatory updates
- Facilitating training and orientation to new employees, and mentor in RA immersion projects in Indonesia
- Ongoing Regulatory Client Support
- Build and maintain active networks at regulatory institutions and industry membership organizations
- Monitor and analyze relevant regulatory developments
- Coach and support the RA specialists in the country
Office Coordinator
• Facilitates and ensure all business licenses are up to date
• Facilitates recruitment process in AMI RAs
• Facilitates resolving issues within AMI organisation
• Prepares reports (Office) for upper management as applicable
Qualifications & Experience
- Bachelor's Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent.
- Graduated as pharmacist/apotechary in Indonesia eligible to become TRP with STRA (Pharmacist Registration Number) registered in Indonesia
- Minimum of 5-8 years of regulatory affairs experience in medical devices and/or IVDs, food supplement and cosmetics
- Strong hands-on experience with Indonesia MOH / Kemenkes regulations and Regalkes system
- Proven experience handling registrations, renewals, and post market regulatory activities in Indonesia.
Skills & Competencies
- In-depth understanding of Indonesian medical device regulatory framework.
- Strong regulatory writing and documentation skills
- Excellent communication and stakeholder management abilities
- High attention to detail and ability to manage mulptiple regulatory projects.
- Proficient in Bahasa Indonesia and English (written and spoken)
- Result oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities
- Computer literate with advanced skills in Microsoft Office (Word, Power Point, etc..)
Preferred Qualifications
- Experience supporting multiple ASEAN markets in addition to Indonesia
- Experience in submission and procurement of Telecom License would be an advantage
- Able to operate in a multicultural environment
- High level of autonomy at work, yet with profound team-spirit
