Full Fledged Pharma & Cosmetics Regulatory Submission Specialist (Perm)

Recruit Express Pte Ltd| Date Posted: 28-Aug-2020
EA Licence No: 99C4599|EA Personal Registration No: R1875164
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Job Nature:
Permanent
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

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


Qualifications/Skills/Experience:

 

  • 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)

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