Regulatory Affairs SG And MY

Regulatory Affairs SG & MY (Based in Singapore)

Main responsibilities

Develop implement and manage strategies & tactics regarding product registration and variation. Develop implement and monitor regional Quality management systems. Collaborate with local Partners/Distributors to accomplish RA .

REGULATORY STRATEGY

• Establish and implement regional and country level regulatory strategic planning according to Corporate Regulatory Affairs policy and South Asia business objectives.
• Identify and contribute regulatory/business opportunities towards the region and globally.
• Manage a comprehensive and efficient regulatory activity database.
• Develop regulatory responses appeals justifications supplements and any other applications in compliance with MOH requirements.
• Stay current on official legislation and orientate team members to understand implication and impact to overall business.
• Develop coordinate and provide technical and legal documentation as required/requested by the importing markets including hospital tender listing.
• Assist Partners to set up local inspections/joint inspections with local health authorities for Good Manufacturing Practices certification.
• Develop effective working relationship with Global RA Affiliate Regulatory Managers and Partner Regulatory managers.
• Where needed lead MA transfer to a designated third party by engaging all necessary stakeholders.

PRODUCT REGISTRATION & VARIATION

• Develop coordinate file and monitor new registration & variation submissions for existing and new products in collaboration with Partners inline with business strategies and local regulations.
• Revise finished artwork of packaging material according to legal requirements and manage alterations with departments involved.
• Implement strategies and tactics with Partners to expedite approvals.
• Collaborate with Partners to develop and maintain a professional relationship with government officials at the various Ministry of Health in the region.

Your profile

• At least 8 years of experience in Regulatory Affairs and Quality Assurance
• Bachelors Degree in Pharmacy
• Understand local regulatory framework regulation and impact on the lifecycle management of our brands.
• Effective interpersonal skills speakup culture and demonstrate abilities to build and maintain relationship with various parties such as HQ Affiliates Partners Government agencies.
• Selfleader organized plans clear long/shortterm goals proactivemindset problemsolver.
• Strategic thinking and business savvy linking to regulatory processes and opportunities.
• Excellent skills in using Microsoft Office especially Excel Power Point.

Remote Work :

No