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 Global Regulatory Affairs Manager, GI in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Global Regulatory Affairs Manager, GI working on the Global Regulatory Affairs team, you will be empowered to lead global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives, and a typical day will include:
- Leads global regulatory team to develop strategies to maximize regulatory success towards achievement of program objectives.
- Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- The Manager role includes managing one or more projects with less complexity. May support GRL on more complex programs. May lead the Global Regulatory Team (GRT), and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Provides strategic and tactical guidance to teams, including regulatory review of clinical trial documents and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance.
- Ensures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.
- Accountable for all US FDA submissions and approvals for project(s) within scope; Serves as the primary FDA contact. The Manager may lead less complex multi-function submissions, such as original INDs or support GRLs for more complex submissions.
- Assists and attends FDA and other agency meetings; may lead with oversight.
- Accountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.
- Oversee vendor responsibility for regulatory activities and submissions related to projects within scope.
- May participate on departmental task-forces or initiatives.
- Partner with functions responsible for ensuring market access and regional GRA leads to understand market access topics and strategize opportunities to strengthen product development plan(s) and build into global integrated regulatory strategy.
- 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 2 year 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.
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.
No Phone Calls or Recruiters Please.