Senior Regional Regulatory Executive (PHARMA MNC/WEST)
Recruit Express Pte Ltd| Date Posted: 22-Jul-2020
EA Licence No: 99C4599|EA Personal Registration No: R1440070
Bachelor's / Honours
- Regional Lead in new registration submissions and life cycle management projects of medical devices, food/health supplements, 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.
- Build a keen understanding of dynamic regulatory frameworks within the region, awareness of legislation changes, in order to assess the impact on licenses and business.
- 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 of bringing EU-approved products 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
- Min Bachelor's Degree in Biological Sciences
- At least 3-4 years of regional regulatory affairs experience, preferably in medical devices, cosmetics and/ or food/health supplement.
- Good project management skills (competent in analytical, written, presentation and communication skills).
For interested candidates, please send your most recent and updated resume to [Click Here to Email Your Resume]
Subject heading: RA Exec
Michelle Lee Ser Min
Recruit Express Pte Ltd
EA License No. 99C4599
Recruit Express Pte Ltd