Senior Director, Head of Global Labeling, Global Regulatory Affairs
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 Senior Director, Head of Global Labeling in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Senior Director, Head of Global Labeling working on the Research and Development team, you will be empowered to take responsibility for Takeda s Global Labeling function, combining knowledge of scientific, regulatory and business issues to ensure compliance with regulatory requirements and Takeda standards. A typical will include:
- Responsible for Takeda s Global Labeling function, combining knowledge of scientific, regulatory and business issues to ensure compliance with regulatory requirements and Takeda standards
- Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- Is a leader both internally and externally, contributing to cross-functional initiatives and influencing the field as applicable.
- Provides leadership and development for direct reports, including those that are responsible for the oversight of global regulatory labeling strategies in collaboration with vendors and regional counterparts.
- Responsible for oversight of the creation and maintenance of product labeling worldwide through CCDS processes
- Leads Global Labeling team to ensure CCDS/labeling documents are prepared and executed in accordance with applicable regulations and company position.
- Oversees regulatory guidance provided to ensure compliance with labeling regulations.
- Accountable for establishing and maintaining a process for ensuring compliance from a labeling perspective, based on internal and external standards.
- Manages personnel within group to ensure coverage for all therapeutic areas and products.
- Understands and interprets complex scientific issues as related to regulatory requirements and labeling strategy. Partners with key internal and external stakeholders to resolve issues.
- Understands broad concepts within regulatory affairs and implications across organization. Proactively identifies labeling issues. Offers creative solutions and strategies, including risk mitigation strategies.
- Responsible for ensuring that key stakeholders and line management are informed of key labeling issues/risks with mitigation plans.
- Develops strategy for efficient and appropriate Global Labeling review and plays a key role in life cycle management strategy and implementation.
- Identifies trends in labeling-related regulatory authority compliance enforcement, policies and procedures; incorporates into regulatory decisions and strategy;
- The Sr. Director will be responsible for overseeing an assigned portfolio of projects or highly complex projects. 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.
- Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
- Oversee vendor activities related to projects within scope.
- Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within Therapeutic Area, across GRA and across R&D.
EDUCATION, EXPERIENCE AND SKILLS:
- BSc Degree, preferred. BA accepted. Advanced scientific degree (MSc, PhD, or PharmD) preferred
- 12+ years of pharmaceutical industry experience. This is inclusive of 10 years of regulatory experience or combination of 8+ years regulatory and/or related experience.
- Knowledge of global standards and regulations related to CCDS and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
- Understand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Demonstrates acceptable skills with increasing independence in 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.
- Responsible for demonstrating Takeda leadership behaviors.
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% 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.