Job Description

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POSITION OBJECTIVES

Act as a strategic regulatory partner in the development and implementation of Growth and Emerging Markets (GEM) strategies in close collaboration with the regulatory teams (GEM, Areas, LOCs) and cross-functional teams.

Is a critical contributor to achieve operational excellence for the GEM RA team and maintain effective communication lines with various stakeholders groups across the organisation.

POSITION ACCOUNTABILITIES:

• Provide strategic and operational support to GEM RA Head in the day-to-day management of regulatory activities including but not limited to:

• Lead cross-TA initiatives aiming at increasing operational effectiveness for the regulatory teams
• Plan and Coordinate GEM RA Leadership Team meetings, GEM RA staff meetings and meetings with Area RA Heads
• Coordinate GEM RA team information exchange and meetings with Mature Product Group RA, Plasma Derived Therapy RA, Vaccine RA and GEM Area heads and LOC RA teams as needed.
• Collaborate with GRA Regional Compliance on process improvements initiatives
• Lead preparation of GEM RA articles in regional and GRA newsletters
• Managing KPI dashboard for GEM RA team

• Cooperate with key stakeholders in GEM BU on activities/initiatives to meet the organizational objectives and requirements, including but not limited to:

• Reporting of Regulatory milestones/timelines to GEM Business Operations
• Provide regulatory support to Access to Medicine Office programs
• Provide Regulatory evaluation of new business development opportunities in GEM and / or participate on due diligence teams.

• Support GEM RA TA leads to define, develop and lead GEM strategies to maximize regulatory success towards achievement of GEM BU and program objectives or to address and minimize emerging regulatory risks.
• Develop effective working models with LOC Regulatory Leads, RA Areas, Regional and Global Regulatory Teams, Cross-Functional teams; company's consultants and Business Partners.

EDUCATION, EXPERIENCE AND SKILLS:

• BS degree in a scientific discipline; degrees in other disciplines may be accepted based on experience. Postgraduate degree preferred.
• 10 years' experience within the biopharmaceutical industry with direct experience in regulatory affairs and/or medical affairs, clinical development, and market access
• Strong experience in working in and/or leading cross-functional projects is highly advantageous
• Strong in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
• Able to work well with colleagues in partner functions, with different country teams and within global teams.
• Effective manager who can bring working teams together for common objectives.

TRAVEL REQUIREMENTS:

• Willingness to travel to various meetings, including overnight trips. Requires approximately up to 10-30% travel.

Locations

Singapore, Singapore

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time