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, GRA Development - GI in our Cambridge MA office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Manager, GRA Development - GI working on the Global Regulatory Affairsteam, you will be empowered to be strategic and innovative, and a typical day will include:
- Oversees as well as executed all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility.
- Manages director reports to support scope of project work.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- Serves as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility or delegates to staff with oversight
- Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
- Primary FDA contact for projects of responsibility or can delegate to staff with oversight.
- Leads the global regulatory subteam (GRT) and represents team at GPT ensures global regulatory strategy written and executed according to plan or oversees if delegated to staff.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
- Responsible for independently achieving all submissions levels, including major submissions (NDA/BLA/MAA); may oversee staff in achieving major submissions.
- Accountable for ensuring all other regulatory submissions within the non-US Americas territories are submitted on schedule by local Takeda affiliates or development partners (eg, PRA or co-development partners) within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- Oversee multiple projects and manager individual projects.
- For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US to ensure regional execution of the strategy as agreed within the global regulatory strategy
- Develop/author and execute global regulatory strategies for more complex strategies. May oversee execution.
- Executes day-to-day activities for projects or delegates to staff with oversight.
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
- Lead and manage Agency meetings.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Identifies and proposes solutions to management for any resource gaps for project responsibility.
- Provides oversight to ensure regulatory compliance of marketed products.
- Present to senior management as requested.
- Usually includes supervision of one or more direct reports.
EDUCATION, EXPERIENCE, BEHAVIORAL COMPETENCIES AND SKILLS:
- BS/BA degree with 5 years in Regulatory or related area, 3 years experience in labeling (or similar skill set) within the pharmaceutical industry.
- Significant knowledge of global standards and regulations related to New Drug Applications, CCDS, and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Demonstrated problem-solving ability with ability to analyze risk and make appropriate recommendations/decisions.
- Excellent oral and written communication skills.
- Demonstrated project management, negotiation, and interpersonal skills.
- Ability to work in a team environment but can function equally well independently.
- 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.
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
- Requires up to 20 % travel.
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.