Posted to MedZilla on 11/14/2019


Takeda Pharmaceuticals

US-MA, Senior Associate, GEM Regulatory Affairs Strategy Lead, Rare Diseases SR0039619-MZ


 
 

OBJECTIVES:

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.

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.