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.
- Routine demands of an office based environment.
- 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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