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Global Regulatory Lead, AD
Takeda is one of the world’s leading plasma manufacturers, offering a broad and differentiated portfolio of plasma-derived products (PDTs) built from a deep understanding of rare diseases and the patient journey. Through our life-saving products, industry-leading plasma donation and manufacturing facilities, cutting-edge R&D and continuing investment in innovation and sustainability, our dedicated Plasma-Derived Therapies Business Unit (PDT BU) seeks to transform the lives of more and more patients worldwide who rely on our therapies.
The Global Regulatory Lead (GRL) in PDT R&D:
- Serves as the global regulatory lead for one or more projects and includes leadership of the Global Regulatory Team (GRT) composed of core regulatory support functions.
- Provides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of plasma-derived therapies, while ensuring compliance with applicable regulatory requirements.
- Serves as the primary liaison to the US FDA and provides support for regional and local regulatory affairs teams for interactions with international regulatory Agencies and Health Authorities in Japan, the European Union and EEA region, Canada and emerging markets.
- Accountable for the creation and execution of global regulatory strategies for assigned programs
- and ensures the global regulatory strategies for assigned programs are up-to-date.
- Collaborates with EU, Japan, China or other regional counterparts and in compiling global regulatory strategies and works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.
- Leads the global regulatory subteam (GRT) and represents the GRT at GPT, cross-functional subteams and working groups.
- Creates high-quality, compliant regulatory documents (e.g., BLAs, INDs, CTAs, MAAs, Variations/ Supplements and other relevant regulatory filings such as PIPs/PSPs, ODDs, meeting requests and briefing packages) for assigned programs within defined timelines as per R&D and business objectives.
- Accountable for all US FDA submissions and approvals for assigned programs. Works cross-functionally with RA and R&D program team members to ensure critical deliverables to countries/regions outside the US are achieved and timely execution of the strategy is met.
- Leads and manages FDA health authorityinteractions/meetingsrelated to assigned programs and supports regional and local regulatory affairs teams with health authority interactions.
- Ensures GRT, GPT, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgment and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with the assigned team and management; understands probabilities of technical success for the solutions. Brings any critical regulatory topics for assigned programs to the regulatory review forum for discussion.
- Ensures accurate, up-to-date reporting of program status and milestones globally through the Inter-ACT system and regulatory dashboard and leverages the Dragonfly visualization tool to highlight any major discrepancies for assigned programs.
- May lead regulatory review in due diligence for licensing opportunities.
DIMENSIONS AND ASPECT
- Strong knowledge of global regulatory requirements for drugs and biologics
- Ability to function as the lead interface with the US FDA and support regional and local regulatory affairs teams with health authority interactions
- Demonstrated ability to develop and implement global regulatory strategies, facilitate approvals, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities
- Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve commercial goals
- Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU, and international markets and versed in the overarching regulatory policy landscape in which biopharmaceutical companies operate
- Extensive experience in US and/or International Regulatory Affairs, including experience with INDs, BLAs/NDAs, MAAs, Pediatric Investigation Plans, Orphan Drug designations, rare disease drug development, innovative trial design and/or expedited regulatory pathways
- Ability to motivate, mentor and manage a diverse team in a matrix environment
- Global perspective with a demonstrated ability to work across functions, regions, and cultures
- Ability to identify potential challenges and opportunities and make recommendations
- Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company
- •Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization
- Invests in helping others learn and succeed
Decision-making and Autonomy
- Accountable for acting decisively and exercise sound judgment in making decisions with limited information
- Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence
- Ability to seek diverse input by balancing multiple internal and external multiple stakeholders to drive solutions and set priorities
- Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution
- Develops executable plans and meets budget and deadlines
- Builds a culture of data-driven decisions
- Ability to challenge self and others to overcome regulatory barriers and deliver high-quality solutions to the business
- Ability to negotiate and influence without authority in a matrix environment
- Crisp decision-making following appropriate consultation, even in times of ambiguity
- Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU
- Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions
- Strong communicator, able to persuasively convey ideas verbally and in writing
- Exceptional communication, negotiation, presentation, and influencing skills across internal and external stakeholders
- A disruptive thinker with the ability to influence and change how PDT used data to make decisions and set priorities
- Continuously challenging the status quo and bringing forward innovative solutions
- Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team
- Delivers solutions to abstract problems across functional areas of the business.
- Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
- Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.
- Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity
- Ability to provide data that will resolve or simplifies complexity between commercial, operations,and strategy
- Resilient and comfortable working through large-scale global change management
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BS degree preferred and advanced degree a plus.
- Minimum of 10 years of pharmaceutical industry experience. This is inclusive of 8 years of regulatory experience with at least 5 years in regulatory strategy and/or a combination of regulatory strategy and equivalent experience
- Plasma or biologics experience preferred
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions
- Strong knowledge of global regulatory requirements and prior FDAinteractions/submissionsexperience
- Ability to use precedent and previous experience to develop innovative/flexible approaches to achieve commercial goals
- Crisp decision-making following appropriate consultation, even in times of ambiguity
- Strong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability
- Must work well with others and within global teams
- Demonstrated leadership
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Job posted: 2022-09-05