Posted to MedZilla on 3/25/2017


Takeda Pharmaceuticals

US-MA, Senior Manager, Global Regulatory Affairs Development 1700552-MZ


 
 

OBJECTIVES:
  • Develops/authors and leads the execution global regulatory development and registration strategies as the primary member of project team for assigned products throughout clinical development cycle gaining buy in from key stakeholders.
  • Develops and applies a comprehensive understanding of global RA regulations and guidelines to projects to enhance probability of regulatory success and regulatory compliance. Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
  • Collaborates with all RA regional leads to ensure a global regulatory strategy is created and executed upon for all projects within project of responsibility.
  • Mentor Associate level personnel

ACCOUNTABILITIES:

  • Support the filing of an sNDA and EU Variation for an indication expansion in multiple myeloma
  • Support a Phase 2 accelerated program in Immunology
  • Plans, executes and manages regulatory submissions for assigned compounds in various phases of clinical development.
  • Accountable for all submissions and approvals for project(s) of responsibility. Negotiates RA matters with regulatory agencies, directly and indirectly for all assigned projects/programs.
  • Accountable for ensuring all other regulatory submissions outside of North America are submitted on schedule by Local or Regional Regulatory Leads via collaboration with leads or collaboration with emerging markets Responsible for ensuring complete submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA). Manages the preparation of responses to regulatory agency queries / oversees completion of activity by others.
  • Fully understands regulatory requirements and their implication on assigned programs, and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
  • Generally serves as the Takeda regulatory lead on the clinical trial working group for individual studies of responsibility liaising with PRA, Takeda s partner, for operational activities.
  • Generally the primary regulatory authority contact for project(s) of responsibility. May be the lead regulatory representative at Agency meetings
  • Ensures 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.
  • Represents Regulatory Affairs on assigned teams.
  • Identifies and proposes solutions to management for any resource gaps for project responsibilities
  • Mentors and coaches Regulatory Associate level staff and facilitates their growth and development.
Qualifications

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • BSc Degree, preferred. BA accepted. Masters or PhD would be a plus.
  • Extensive pharmaceutical industry experience. This is inclusive of sizable regulatory experience or combination of broad regulatory and/or related experience.
  • Oncology and/or rare disease experience strongly preferred
  • Experience in reviewing, authoring, or managing components of regulatory submissions.
  • Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA regulations and processes mandatory.
  • Knowledge of EU, Canada, Japan regulations and processes desirable.
  • Post-marketing experience would be a plus.
  • Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.
  • Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
  • Demonstrates acceptable skills with increasing independence in the area of 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.
  • Must work well with others and within global teams.
  • Able to bring working teams together for common objectives.
PHYSICAL DEMANDS:
  • Routine demands of an office based environment.
TRAVEL REQUIREMENTS:
  • Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
  • Requires approximately 5 % travel.

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