Healthcare expert Plasma Products
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Project Overview
A top tier global consulting firm is seeking a healthcare expert with deep experience with Plasma Products specifically in relation to gaining regulatory approval for plasma products for a new type of indication in the Indonesia market. This would require someone with a strong network into BPJS BPOM and MOH
The focus of this consulting oppotunity is to help a healthcare client accelerate the regulatory approval process of a plasma-derived product for a new indication in Indonesia ensuring compliance with local regulatory requirements and facilitating swift market entry.
Key areas of support:
- Regulatory Strategy & Planning:
- Help develop and implement a focused regulatory strategy aligned with Indonesian health authorities (BPOM) aiming to expedite approval for the new indication through available pathways and incentives.
- Regulatory Submission & Documentation:
- Support the preparation compilation and submission of all necessary dossiers including registration applications registration dossiers and any supplemental documentation required by BPOM.
- Stakeholder Engagement & Advocacy:
- Support interaction with Indonesian regulatory authorities ensuring strong communication channels participating in meetings and advocating for accelerated review processes such as priority review or special pathways.
- Alignment with Clinical & Manufacturing Teams:
- Help assess whether clinical data manufacturing practices and quality documentation meet Indonesian regulatory standards facilitating smooth review and approval processes.
- Assessment & Mitigation of Regulatory Risks:
- Identify potential regulatory challenges specific to Indonesia and help develop mitigation strategies and respond efficiently to inquiries or additional data requests.
- Market Access & Commercial Readiness:
- Support commercial teams to prepare for rapid market access following approval including understanding reimbursement pathways registration requirements and local stakeholder needs.
Qualifications & Experience:
- In-depth knowledge of Indonesian regulatory landscape including BPOM processes regulations and approval pathways.
- Proven experience in registering biologics or plasma products within Indonesia.
- Familiarity with regulatory strategies for expedited approval for innovative or orphan indications.
- Strong communication negotiation and stakeholder engagement skills in the Indonesian regulatory environment.
- Experience working with clinical manufacturing and quality teams to facilitate smooth approval processes.
Key Skills
- Revenue Cycle Management
- HIPAA
- Healthcare Management
- PMBOK
- Microsoft Outlook
- Project Leadership
- Data Management
- Project Management
- Affiliate Marketing
- Project Management Software
- Supervising Experience
- Workday
