- Defines, develops and leads Emerging Markets strategies to maximize regulatory success to strengthen the product development plan, to enable patient access and to achieve appropriate price and reimbursement in alignment with program objectives, including all aspects of submission and timely approval of investigational applications, market application and life-cycle management.
- Provide direction, support, mentoring, and strategic guidance to support scope of project work, when applicable.
- Responsible for demonstrating Takeda leadership behaviors.
- Defines, develops and leads Emerging Markets strategies to maximize regulatory success towards achievement of program objectives.
- Independently manages, plans and directs all aspects for the successful preparation, submission and timely approval of investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program.
- Effectively communicates the regulatory strategies, submission plans and timelines; and impact assessments of trends, regulations and changes related to assigned programs.
- Stays current with regulations / guidances in Emerging Markets for impact on drug development plans, registration and life-cycle management to maximize the positive outcomes of the regulatory applications and maintain registration compliance.
- Provides regulatory expertise on Emerging Markets for multiple projects including one highly complex program, focused on non-clinical and clinical aspects of drug development, registration and / or post-marketing compliance and life cycle management.
- Assures ongoing efforts towards fulfillment of international product approval conditions for late stage programs.
- Develops effective working relationships with Local Regulatory Lead, Regional and Global Regulatory Team, Cross-functional Teams; company s consultants and Business Partners.
- Evaluates new business development opportunities for 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 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 to and / or mentors team members, if required, to support scope of project work.
- Partner with the regional/LOC market access and LOC RA colleagues to understand market access and reimbursement topics and support opportunities to drive consolidated inputs into regional product development plans.
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
- 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 post-marketing phases.
- 8 years of directly related regulatory experience is desirable.
- Solid regulatory experience, including knowledge of regulations and guidances 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 managing relationships with CROs and/or contractors also preferred.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
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