Manager - Scientific & Regulatory Affairs Pharmacist (Pharmaceutical)

Mega Lifesciences Public Company Limited

Mega Lifesciences Public Company Limited (Bang Na)

Bang Na

Bangkok, Thailand

Established in 1982, Mega Lifesciences public company limited is actively involved in helping millions of people have access to safe, effective, world class quality nutritional & herbal supplements, OTC and pharmaceutical products. From Thailand to the world, Mega is engaged in manufacturing, marketing, selling and distributing quality pharmaceutical, nutraceutical products and Fast Moving Consumer Goods (FMCG). Headquartered in Bangkok, we have our presence in more than 30 countries across the globe. At MEGA, We care for the customer – the doctor, the retailer & you. We care for “Human Wellness”; our first objective is to help people stay healthy. Our values are based on Truth, Trust, Respect and Freedom. Our way of life provides a learning environment wherein you change before you are forced to and help to build a Company that will live beyond each of us. We create value by marketing and selling medicines in developing countries. With two world class manufacturing facilities in Thailand and one in Australia, Mega operates over 30 countries employing 5,000 colleagues. At Mega you will drive your future and the future of this company.

Detail posisi

Mega Lifesciences is looking for a Manager – Scientific & Regulatory Affairs to work closely with the Director – Scientific & Regulatory Affairs in a fast-paced environment that will offer ample opportunity to learn and expand your experience and expertise.

Kewajiban

As a Manager - Scientific & Regulatory Affairs, your key tasks are as follows:
• Manage all activities related to product registration for Pharmaceutical products, OTC, Ethical, Biological products and other categories.
• Review and evaluate the product documentation along with coordination for any additional documents, clarifications, samples, etc. as required for product registration.
• Make sure that all submissions/approvals comply with the laws, guidelines, regulations and practices in Thailand.
• Communicate the approved information &/or any changes to the concerned departments within/outside the company.
• Take initiative in local government affairs activities by cultivating close relationships with government agencies in order to influence and respond proactively to the development of laws and regulations governing product registrations.
• Provide input and advance notification on potential regulatory & quality risks and propose/develop preventive and corrective strategies by exploring ways for registrations.
• Maintain a high level of regulatory intelligence by staying abreast on existing and developing regulations, guidelines, laws and overall competitive landscape in the regulatory domain.
• Manage and coordinate all Pharmacovigilance activities for the products according to Thai FDA regulations.
• Ensure documentation of the registered products.
• Develop and coach team members to meet goals and objectives set.
• Lead the team to ensure prioritized objectives that focus on the critical activities are successfully delivered on time and on quality.

Kualifikasi

Applications are invited from the potential talents who meet the following criteria:
• Bachelor’s Degree or Master’s Degree in Pharmacy.
• At least 5 years experiences management in pharmaceutical industry or in Drug Regulatory affairs.
• Pharmaceutical products, OTC, Ethical, Biological products and other categories is an advantage.
• A pharmacist license is necessary.
• Good networking skills and result-oriented.
• Professional use of MS Office.
• Proficiency in English language – speak, read, write.
• Ability to multitask and deliver on multiple projects.
• Excellent working relationship with Thai FDA and demonstrated success in key negotiations.