Job Overview:
Key Responsibilities:
- Stay abreast of current regulations, guidelines, and industry trends to ensure compliance and provide regulatory guidance to project teams.
- Assist in the preparation and review of labeling, promotional materials, and other product-related documents to ensure compliance with regulatory requirements.
- Participate in regulatory agency interactions, including meetings, teleconferences, and written correspondence, to address inquiries and resolve regulatory issues.
- Conduct regulatory assessments of product changes, deviations, and quality issues, and provide recommendations for resolution.
- Support the development and implementation of regulatory strategies to expedite product approvals and optimize market access.
- Maintain regulatory databases, files, and records in accordance with company policies and regulatory standards.
- Assist in the preparation and review of standard operating procedures (SOPs), work instructions, and training materials related to regulatory compliance.
- Participate in internal and external audits and inspections, as necessary, and ensure timely resolution of any findings.
Qualifications:
- Bachelor of Pharmacy (Pharm.D.) or equivalent degree from an accredited institution. Advanced degree (e.g., Master of Pharmacy, Ph.D.) preferred.
- Registered pharmacist with current licensure to practice pharmacy in the relevant jurisdiction.
- Minimum of (X) years of experience in regulatory affairs within the pharmaceutical industry, preferably in a global regulatory environment.
- In-depth knowledge of regulatory requirements for drug development, registration, and post-approval activities in key markets (e.g., FDA, EMA, Health Canada, etc.).
- Strong understanding of pharmaceutical quality systems, Good Manufacturing Practices (GMP), and Good Clinical Practices (GCP).
- Excellent analytical, organizational, and problem-solving skills, with meticulous attention to detail.
- Proven ability to collaborate effectively with cross-functional teams and communicate complex regulatory issues clearly and concisely.
- Ability to manage multiple priorities in a fast-paced environment and adapt to changing priorities and deadlines.
- Certification in Regulatory Affairs (e.g., RAC) desirable.
**Salary**: Rp8,000,000 - Rp10,000,000 per month