Manager, Global Regulatory Affairs Development Oncology - United States
Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Manager, Global Regulatory Affairs Development in ourCambridge MAoffice.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, Global Regulatory Affairs Developmentworking on theGlobal Regulatory Affairsteam, you will be empowered toinnovative andcollaborative, and a typical day will include:
·Manages the global registrations and life cycle management of an oncology product in EU, Japan, Canada, and emerging market regions.
·Plans/manage/executes all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities for assigned marketed product of responsibility.
·Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
·Collaborates with all Takeda regions and/or business partners to ensure theglobal regulatory strategy is executed upon for all projects within project of responsibility.
·May serve as acontact for FDA or other health care angeices for project of responsibility as needed.
·Accountable for ensuring all other regulatory submissions within the non-USterritories are submitted on schedule by local Takeda affiliates and/or business partners within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
·Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
·For the project(s) of responsibility, collaborates with EU Regulatory Affairs, other regional counterparts and/or business partners ensuring critical deliverables to territories are provided outside the Americas to ensure regional execution of the strategy
·Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
·Generally serves as regulatory lead on the global cross functional team for individual project(s) of responsibility. Collaborates with all Takeda regions and/or business partners to ensure a global regulatory strategy is created and executed upon for all projects within project(s) of responsibility.
·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, India, etc. but also including other developed countries such as Australia, S. Africa). Where necessary, this individual will manage CRO/contractor support for agreed predefined standards to meet planned project needs and ad hoc advice.
·Executes day-to-day activities for projects.
·Manages individual projects.
·Assists and attend FDA and other agency meetings.
·Identifies and notifies management of resource gaps for assigned project(s), when necessar
·Ensure regulatory compliance of marketed products.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
·BSc Degree, preferred. BA accepted.
·Minimum of 4 years of pharmaceutical industry experience. This is inclusive of 3 years of regulatory experience or combination of 4 years regulatory and/or related experience.
·Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
·Basic working knowledge of drug development process and regulatory requirements.
·Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
·Demonstrates acceptable skills in 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.
·Acceptable and independent skills 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.
- Routine demands of an office based environment.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
Takeda is an EEO employer of minorities, women, disabled, protected veterans, and considers qualified applicants with criminal histories in accordance with applicable laws. For more information, visit http://www.takeda.us/careers/EEO_Policy_Statement.aspx
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