Senior Associate, GEM Regulatory Affairs Strategy Lead, Rare Diseases

Company: Takeda
Location: Cambridge
Posted on: December 5, 2019

Job Description:

Executes and support the development of the regulatory submission strategy of investigational applications, market applications, and general product life cycle management of assigned program. Accountabilities * Assists supervisor as necessary in the development of the Emerging Markets regulatory strategies to ensure country-specific regulations and local environments are identified and appropriately planned. * Executes and support the development of the preparation of regulatory documents required for investigational applications, market applications, variations, post approval reporting obligations and general product life cycle management of assigned program. * Manages the preparation of ancillary documents; * Develops knowledge of regulation / guidances in Emerging Markets related to drug development plans, registration and life-cycle management. * Execute regulatory activities assigned by supervisor to fulfill international product approval conditions for late stage programs. * Develops working relationships with Local Regulatory Lead, Regional and Global Regulatory Teams. * Develops a solid understanding of local regulatory requirements, with emphasis on those related to assigned program enabling flawless preparation of submission related documents. * Supports preparation activities for meetings with Health Authorities and meeting outcome for the assigned program, as required. Education,_Behavioral_Competencies_And_Skills * BS/BA degree in a scientific discipline. Advanced degree preferred. * Experience within the pharmaceutical industry and including direct experience in regulatory affairs in development and /or post-marketing phases is desirable. * 2 years of directly related regulatory experience is desirable. * Fundamental knowledge of the relationship of scientific data and regulatory requirements. * Able to demonstrate acceptable basic skill sets such as oral and written communications, managing and adhering to timelines, project management skills, integrity and adaptability. * Good working understanding of projects in assigned area of responsibility allowing for creative and innovative solutions to address potential hurdles inherent in Emerging Markets drug product registration. * Demonstrates basic understanding of regulatory strategy such as broad concepts within regulatory affairs and implications across the organization and globally. Physical_Demands * 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 Travel_Requirements * Willingness to travel to various meetings, including overnight trips. * Requires approximately up to 10-30% travel.

Keywords: Takeda, Boston , Senior Associate, GEM Regulatory Affairs Strategy Lead, Rare Diseases, Other , Cambridge, Massachusetts