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

Senior Regional Regulatory Affairs Executive