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In-house & Third-Party OTC Products
Team Leadership Role
The company is a noted conglomerate, progressively raising and enhancing its capabilities in Asia, North America and the GCC & Africa region. Its core business activity is pharmaceutical manufacturing & distribution supported by FDA-approved facilities in the US and Asia. Following some organisational restructuring, the company wishes to a appoint an experienced Regulatory Affairs Manager in Yangon.
Reporting to an expatriate CEO whilst leading a small team, the appointed individual will be responsible for managing the end-to-end of the regulatory affairs function. This will include maintaining awareness of legislative changes, whilst building strong external relationships, and advising and appropriately amending internal processes whilst managing on-time submission of documents to the FDA and local authorities for product registration approval. The scope will necessarily include managing the RA department to ensure effective strategies and processes are developed and implemented to improve the accuracy and efficiency of the team, underpinned by appropriate training and development programmes. In addition, the role will monitor materials quality and cost to meet regulations as well as manufacturing standards whilst also scheduling product trials and associated regulatory inspections. Last, but not least, the appointed individual will ensure that FDA approvals are secured on time to ensure seamless importation and custom clearance of materials/products to optimise the sales cycle.
Interested candidates should offer a Degree and/or Masters in Pharmacy or MedTech and a minimum of 5 years’ experience within regulatory affairs management that includes deep local and international knowledge of pharmaceutical legislation and procedures supported by a demonstrable record in applying such guidelines to company processes and product registration dossiers. Aside from bi-lingual Myanmar and English language proficiency, interested candidates should be self-motivated, pro-active and offer first-class planning and organisational skills. Attention to detail is imperative whilst building and maintaining key government and FDA stakeholder relationships is equally vital.