- Develops and leads the execution of Emerging Markets regulatory strategies for product lifecycle, including product development and pre-/post-marketing (all therapeutic areas, biologics and small molecules).
- Interfaces cross-functionally within RA, as well as with commercial, clinical development, global marketing, etc. to identify what Emerging Markets regulatory requirements are necessary and how to best move forward to meet project plans.
- Ensures execution of the strategy to ensure proper facilitation and preparation of international regulatory documents and various submissions, as well as any compliance matters;
- Develops and applies a comprehensive understanding of Emerging Markets RA regulations and guidelines by applying interpersonal skills and expert RA Emerging Markets knowledge to address and overcome challenges that arise during development and commercialization.
- Manages interactions with Emerging Markets Health Authorities as necessary, successfully negotiating international matters.
- Plans and executes the regulatory submissions to support product development and approval efforts for all products (all indications) in non-US and EU countries (e.g., primarily focusing on the emerging markets including Asia Pacific, Latin America, Russia & CIS, Middle East / Africa). Where necessary, this individual will oversee and select CROs/contractor support for agreed predefined standards to meet planned project needs and ad hoc advice.
- Evaluates country-specific regulations and local environments to assess impact and provide guidance. Helps define strategic direction in the development of the Emerging Markets component of the Regulatory Development Plan for programs in development.
- Stays current with revised regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
- Works closely with functional areas throughout the company. Advises functional areas regarding content requirements for Emerging Markets regulatory submissions; review documents from functional contributors for consistency and completeness.
- Leads or supports preparation activities for meetings with HA, as required. Interacts directly with HA as required. Represents Takeda Emerging Markets in Health Authority meetings.
- Develops in-depth knowledge of regulatory requirements and environment for development and registration of new products for all Emerging Markets region such as Asia Pacific, Latin America, etc.
- In liaison with Global Regulatory Lead (GRL), helps develop core labeling for products with considerations for Emerging Markets requirements
- Responsible for ensuring that project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS/BA Degree in a scientific discipline. Preferred advanced degree (MS/PharmD/PhD).
- A minimum of 6 years of directly related regulatory international bio/pharmaceutical experience.
- Solid knowledge of regulations, policies, procedures, drug development guidelines and compliance for all emerging and selected developed markets
- Proven ability to liaise with Regulatory Agencies having served as lead in Agency interactions and product development meetings.
- Demonstrated leadership, problem-solving ability, flexibility and teamwork.
- Experience managing relationships with CROs and/or contractors.
- Proven ability to provide strategic regulatory guidance to drug development, registration and post-market support team.
- Good working understanding of projects in assigned area of responsibility allowing for creative and innovative solutions to address potential hurdles in development.
- Strong negotiation and communication skills and the ability to work independently and function well in a team-oriented environment are essential.
- Able to deal with issues of critical importance, provides regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance.
- Excellent written and oral communication skills required.
- Active participation in Agency/Industry groups/forums preferred.
- Knowledge of eCTD
- Routine demands of an office based environment.
- 5-10%; some international travel may be required
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