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 in-line 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 inter-personal skills, speak-up culture and demonstrate abilities to build and maintain relationship with various parties such as HQ, Affiliates, Partners, Government agencies.
• Self-leader, organized, plans clear long/short-term goals, proactive-mindset, problem-solver.
• Strategic thinking and business savvy, linking to regulatory processes and opportunities.
• Excellent skills in using Microsoft Office especially Excel, Power Point.