Regulatory Affairs Manager

Key Responsibilities:

Project Execution

• Accountable/responsible for project execution and/or providing training/mentoring to junior team members for different regulatory services and covered technical discipline(s) included but not limited to CTD authoring, CTD document preparation, country submission, gap analysis, consultation, regulatory project coordination, management, and strategy with less guidance.
• Responsible for consulting activities for the covered technical discipline(s) especially on issues that lack precedence or are not clearly defined, regulatory project governance, and client’s pipeline management with guidance.
• Applies the appropriate consulting methodologies and designs/improves the methodologies, tools, and intelligence to enhance the efficiency and quality, as applicable, with less guidance.

Commercial Support

• Develops business solutions specific to clients’ needs utilizing experiences and best practices with guidance.
• Supports project scoping for RAS services and proposal preparation with less guidance.
• Delivers sales presentations and participates in bid defense meetings with less guidance.

Preferred Experiences and Skills:

• Bachelor’s degree or above in life science, pharmacy, medical or industry related discipline (pharmacology, pharmaceutical analysis, biological science, cell and molecular biology, molecular engineering, chemical engineering or medical related).
• Numerous years of experience in consulting from the relevant health industry is also valuable.
• Competent in written and oral English and Mandarin.