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 aSenior Manager, GRA Labeling in ourDeerfield, ILoffice.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Senior Manager, GRA Labeling working on theGlobal Regulatory Affairs team, you will be empowered tobe strategic andinnovative, and a typical day will include:
- Develops/authors and leads the execution of global labeling as the primary labeling representative on project teams for assigned products throughout clinical development cycle gaining buy in from key stakeholders.
- Develops and applies a comprehensive understanding of global labeling regulations and guidelines to projects to enhance probability of obtaining optimal product labels. Provides a regulatory strategic focus on labeling aspects of drug development and associated regulations.
- Serves as Global Labeling Lead (GLL) on the Regulatory Subteam for individual project of responsibility. Can have multiple projects depending on development stage and complexity.
- Collaborates with all Takeda stakeholders to ensure a global labeling strategy is created and executed upon for all projects within project of responsibility.
- Identifies key issues associated with product labeling compliance and provides mitigation strategies for consideration by management.
- Provides labeling support and leadership (as required) in preparation of labeling documents for initial registrations for ICH countries, e.g., USPI, SmPC, Japan PI.
- May mentor or supervise Associate or Sr. Associate-level personnel
- Plans, executes and manages regulatory labeling for assigned compounds in various phases of clinical development.
- Leads the CCDS working team and represents team at labeling committee; ensures global labeling strategy is consistent with overall regulatory strategy and executed according to plan.
- Accountable for enabling regulatory labeling submissions by local Takeda affiliates within project(s) of responsibility by ensuring the regulatory labeling deliverables are provided in a timely fashion consistent with the project plan.
- For the project(s) of responsibility, collaborates with global colleagues and other regional counterparts ensuring critical deliverables to territories are provided outside of region to facilitate regional execution of the strategy as agreed within the global regulatory strategy
- Fully understands regulatory labeling requirements and their implication on assigned programs, and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Serves as global labeling lead on the Regulatory Subteam for individual project(s) of responsibility.
- Ensures project team colleagues, line management, and key stakeholders are apprised of labeling developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner.
- Manage individual projects with greater complexity
- Provides regulatory labeling expertise and guidance in the due diligence review of licensing opportunities.
- Creates and negotiates labeling agreements with partners, when required. Responsible for ensuring compliance with labeling agreements for projects within scope of responsibility.
- Identifies and proposes solutions to management for any resource gaps for project responsibilities
- Collaborate with stakeholders and LOCs to ensure regulatory labeling compliance of marketed products.
- Mentors and coaches Regulatory Associate and Sr. Associate level staff and facilitates their growth and development.
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
- BSc Degree, preferred. BA accepted.
- 6+ years of pharmaceutical industry experience inclusive of 5 years of regulatory labeling experience or equivalent.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Solid working knowledge of drug development process and regulatory requirements. Knowledge of FDA, EU, Canada, ROW and post-marketing a plus.
- Understand and interpret complex scientific issues across multiple projects as it related to labeling requirements and strategy.
- Understands and interprets scientific data as it relates to labeling 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 labeling strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies labeling 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 labeling strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory labeling issues; offers creative solutions and strategies, including risk mitigation strategies
- Willingness to travel to various meetings or client sites, including overnight trips. Some international travel may be required.
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.