Associate Director, Regulatory Affairs, Gi

2 weeks ago

Singapore Takeda Pharmaceutical Full time

OBJECTIVES:

  • Develop team members and provide direction, support, mentoring, and strategic guidance to support scope of project work, when applicable.

ACCOUNTABILITIES:

  • Responsible for demonstrating Takeda leadership behaviors.
  • Defines, develops and leads Growth-Emerging Markets strategies to maximize regulatory success towards achievement of program objectives.
  • Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs.
  • Provides regulatory expertise on Growth-Emerging Markets for multiple projects including one highly complex program, focused on nonclinical and clinical aspects of drug development, registration and / or postmarketing compliance and life cycle management.
  • Assures ongoing efforts towards fulfilment of international product approval conditions for latestage programs.
  • Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Crossfunctional Teams; company's consultants and Business Partners.
  • Evaluates new business development opportunities for Growth-Emerging Markets and / or participates on due diligence teams.
  • In coordination with local regulatory lead provides strategic guidance / advice on emerging trends, regulations and changes, with emphasis on those related to assigned program enabling proactive approach and planning to future business needs.
  • Leads or supports preparation activities for meetings with Health Authorities for the assigned program, as required. Interacts directly with HA, as required. Represents Takeda Growth-Emerging Markets in Health Authority meetings. Effectively communicates and manages meeting outcome and next steps, as required.
  • Manages, trains, provide direction, strategic guidance and solutions to projects or mentors team members, if required, to support scope of project work.
  • Partners with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and supports opportunities to drive consolidated inputs into regional product development plans.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BS degree in a scientific discipline; BA accepted based on experience. Advanced degree preferred.
  • Considerable pharmaceutical industry experience. This is inclusive of thorough regulatory experience or a solid combination of regulatory and/or related experience in both development and /or postmarketing phases.
  • 8 years of directly related regulatory experience is desirable.
  • Solid regulatory experience, including knowledge of regulations and guidance governing drugs and biologics in all phases of development for emerging markets and US and/or EU (relevant to role) as well as leading interaction with Health Authorities.
  • Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies.
  • Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy.
  • Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Generally strong and independent skills in regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.
  • Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership
  • Generally strong leader who is effective manager and can bring working teams together for common objectives. Able to mentor and develop skills of team members.
  • Experience in managing personnel preferred; experience managing relationships with CROs and/or contractors also preferred

TRAVEL REQUIREMENTS:

  • Approximately up to 1030% travel.

Locations:

Singapore, Singapore

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

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