POSITION SUMMARY:
The Senior Regional Regulatory Executive will be a key member of the team responsible for new registration submissions and management of product life cycle of medical devices, cosmetics, or assigned product portfolio in Asia Pacific. The Senior Regional Regulatory Executive will work across different regional functions and with country regulatory contacts to ensure alignment in planning and execution of the regulatory projects.
KEY RESPONSIBILITIES:
Product Registration and Product Life Cycle management
- Regional Lead in new registration submissions and life cycle management projects of medical devices and cosmetics in APAC regions. Examples for life cycle projects include technical variations (such as change in manufacturer, formulation change, etc).
- Regional Lead in regulatory-status re-classification projects to serve commercial marketing needs.
- Timely management and execution of registration activities for assigned product portfolios, responsible to monitor and provide update of project progress to completion to stakeholders.
- Work closely with manufacturers and country regulatory teams for prompt response to submission queries, ability to analyze and identify gaps to address Authority needs.
- Review and approve artwork for Asia Pacific with base knowledge of labelling requirements in individual countries according to in-house artwork system, ability to address and resolve labeling issues when required.
- Maintain medical device dealer licenses and class A licenses (Singapore) on behalf of regional office and support cross-border E-commerce registration initiatives.
- Maintain and upkeep regional regulatory databases.
- Demonstrate the ability to identify, articulate and communicate regulatory assessments to multiple stakeholders to support in-country regulatory requirements and business needs according to business plans.
- Provide legitimate solutions (e.g. reformulation, redressing, commitment letters, bridging reports, etc) to overcome regulatory hurdles, reduce inventory risk and lessen regulatory deficiencies to achieve speed to market
- Establish good rapport and strong working relationships within internal regulatory team, relevant regional stakeholders and Corporate.
- Assist business initiatives by providing regulatory assessments for product improvements or re-classification projects
Regulatory Frameworks & Compliance
- Build a keen understanding of dynamic regulatory frameworks within the region, awareness of legislation changes, in order to assess the impact and identify relevant actions to maintain and new submissions on licenses.
- Comply with regional and corporate regulatory and quality SOPs and policies, support regulatory compliance activities such as audits, licensing due diligence checks.
- Assess regulatory viability with country regulatory affairs by reviewing data such as formulation, intended use, clinical, safety and manufacturing data and highlighting gaps and resolutions
- Sits independently in cross-functional teams, manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality affairs
- Manages relationship with external regulatory stakeholders: product owners, manufacturers, distributors, external consultants
- Other ad-hoc duties requested time from time from superior/cross-functional colleagues
KEY REQUIREMENTS:
- At least a Bachelor's Degree in Biological Sciences / Biomedical Engineering / Engineering
- At least 2 years of regional regulatory affairs experience, preferably in medical devices and cosmetics
- Knowledge in ISO13485 is an advantage.
- Details orientated, ability to multi-task, self-motivate, show persistence and resilience in overcoming challenges
- Able to assimilate complex and extensive information and condense it for management decisions
- Good project management skills (competent in analytical, written, presentation and communication skills).
- A good team player who can work independently, able to influence and collaborate effectively across different functions and at all levels
- Adaptable to changes to facilitate successful project outcomes.
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
