Regulatory Affairs Manager
Working with a dynamic team
About Our Client
Our client is a leading manufacturing company within the ceramics business. One of the leading brand in the ceramic industry and a brand that continues to grow in the region. With multi-million tonnes milling capacity per year, they are a business with rapid growth and strong branding over the years. As part of the growth plans and the building of a strong name and reputation, they are looking for a proven Director, Manufacturing to manage total manufacturing activities in Indonesia
- Manage and provide strategy on the preparation of the Registration Dossier for registration, variation and renewal for the product category in OTC drug, Medical Devices, Cosmetics, Food supplement, quasi drug and food nutrition including export country for submission to the regulatory agencies (BPOM MOH, Halal authority, etc).
- Manage internal coordination with Multi Functional team (Brand, MKT, Supply and Demand, Quality, Sales, Supply, etc) for planning registration timeline and labeling development
- Provide strategy and manage the regulation requirements and interconnection for new product introductions (NPI) and current products in associated with site transfer, Joint Venture and third party contract manufacturing to get approval on Marketing Authorization (MA) in timely manner.
- Manage the strategy to maximize the claim approval opportunities following Claim Support and scientific innovation framework for product label and advertisement.
- Manage to Provide regulatory inputs and advices to International Regulatory Contact, Medical, Supply chain GMS team and LOC to ensure safety, Global Data Sheet, Pharmacovigilance and regulatory compliance are achieved.
- Manage and develop a good relationship with the local regulatory agencies ((Ministry of Health/MOH, NADFC/Board of Health/BOH, Key Experts - Drug committee, nutritionist and etc) for regulatory activities, discussion, issue and crisis to influence strategically the government regulatory bodies in modernizing the local regulation for streamline regulatory process.
- Manage external coordination and communication with local authorities Support process to notify the organization when regulation changes arise, acting as a reference point for different departments and contacting government agencies in attempt to clarify matters.
- Manage issue and crisis related to regulatory environment and provide risk assessment and recommendation accordingly.
The Successful Applicant
Academic/ Professional Qualifications
- University Graduate in pharmacist or science, post graduate would be an advantage
- English Language - written and spoken fluently
- Bahasa Indonesia - written and spoken fluently
- Must be able to communicate clearly and concisely in both languages
- Min 5 years of experience in regulatory position with a reputed Pharmaceutical or Consumer Health Company with working experience in managing registration for drug products and others (optional).
- Experiencing in changing regulatory environment i.e. proposing the change of regulatory system/regulation.
- Had been exposed to quality, production & R&D environment.
Specialized knowledge or skills required
- Strong logical and technical skills.
- Mastering the Indonesia registration regulation and its related regulation.
- Having a good relationship with government official and associations.
- Bridging the external and internal requirement.
- Knowledgeable in quality system and product development system.
What's on Offer
- Opportunity to be a part of a leading business for a leading brand
- The chance to grow with a global MNC