Full Fledged Pharma & Cosmetics Regulatory Submission Specialist (Perm)
Product Registration and Product Life Cycle management
- 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.
Regulatory Frameworks & Compliance
- 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
- Other ad-hoc duties requested time from time from superior/cross-functional colleagues
- Candidate must possess at least a Bachelor's Degree in Biological Sciences
- At least 2 years of regional regulatory affairs experience, preferably in medical devices, cosmetics and/ or food/health supplement.
- Details orientated, ability to multi-task, self-motivate, show persistence and resilience in overcoming challenges
- 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.
Interested candidates please submit your resume to [Click Here to Email Your Resume]
Jace Choo Oi Kei
Personnel EA License No.: R1875164
Recruit Express Pte Ltd (EA Licence No.: 99C4599)
Recruit Express Pte Ltd