POSITION SUMMARY:
The Senior Regional Regulatory Executive will be a key member of the team responsible for new registration submission and management of product life cycle of pharmaceutical products in Asia Pacific.
KEY RESPONSIBILITIES:
- Regional Lead in registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater China, Hong Kong & Macau, Taiwan, India, South Korea, Australia and New Zealand and in emerging markets e.g. Maldives, Sri Lanka, etc.
- Regional Lead in change management and compliance in APAC regions
- Regional Lead in line extension projects to serve commercial marketing needs
- Assess regulatory viability of bringing EU-approved products with local regulatory colleagues through understanding the quality, non-clinical and clinical data of the products to meet country- specific requirements
- Provide solutions to overcome regulatory hurdles, meet compliance requirements, reduce inventory risk and also shorten dossier preparation time so to achieve speed to market
- Artwork approver of APAC common-pack and specific-pack artworks with knowledge of labelling requirements in individual countries
- Able to represent regulatory affairs in cross-functional team and manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality assurance
- Develop relationships with various partners regulatory function stakeholders: product owners, manufacturers, distributors, external consultants
- Maintain relevant databases for registrations and status as required
- Other ad-hoc duties requested time from time from superior/cross-functionalcolleagues
KEY REQUIREMENTS:
- Candidate must possess at least a degree in Pharmacy/Pharmaceutical Sciences or equivalent
- At least 3 years of regional regulatory affairs experience on pharmaceuticals with track records of lifecycle and/or new registrations across multiple markets.
- Attention to details and resilient in overcoming challenges.
- Ability to collaborate and work at a fast pace in multidisciplinary matrix organisations.
- Easily adapts to IT systems to help facilitate work processes.
ABOUT MENARINI ASIA-PACIFIC
We are a global, family-owned healthcare company where our people are our priority. Present across 13 markets in Asia-Pacific, here's why you should join us:
- Local Market Expertise, Global Footprint: As a global family-owned company, we value local knowledge and expertise to invigorate the lives of patients, people and partners
- Inclusive Flexible Workplace: We are committed to foster a culture of respect and inclusive teamwork to ensure equal opportunities in a flexible workplace
- Versatile Learning and Vibrant Opportunities: Our diverse portfolio of products in varied therapeutic areas across prescription and consumer health presents opportunities for you to take ownership of your career
- Empowered to be Entrepreneurial: We operate in a dynamic, low-bureaucracy environment where swift decision-making allows us to make a real impact
- Sustainability and Care: Be part of a company that cares. Together, commit to sustainable workplaces
Join us and invigorate lives! For more information about Menarini Asia-Pacific, please visit www.menariniapac.com
