Senior Pharma Regulatory Affair Specialist **PERM**
- Regional Lead in new registration submissions of pharmaceutical products in APAC regions: ASEAN, Greater China, Hong Kong & Macau, Taiwan, India, South Korea, Australia and New Zealand and in new frontier markets eg. 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 legitimate solutions (redressing, commitment or justification letters, review and amend study protocol etc) to overcome regulatory hurdles, 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
- Propose best recourse of action to meet compliance requirements for legacy non-compliance issues
- Sit independently in cross-functional team and manages relationships with internal stakeholders: marketing, supply chain, medical affairs, quality assurance
- Manage 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-functional colleagues
KNOWLEDGE/ QUALIFICATIONS / SKILLS / EXPERIENCE:
- Candidate must possess at least a Bachelor's Degree in Science Related Course (degree in Pharmacy will be advantageous)
- At least 4 years of regulatory affairs experience on pharmaceuticals
- Proficient in both oral and written English. Knowledge of Mandarin is a plus.
- Attention to details.
- Ability to influence and collaborate with people at all levels effectively.
- Computer literate
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