The R&D organization of the Plasma-Derived Therapies Business Unit (PDT BU) is dedicated to bringing forward new therapeutic approaches based on plasma-derived therapies for patients with rare and complex diseases. Takeda believes there is tremendous potential to do more to meet patients’ and health care providers’ expectations with plasma-derived and plasma-oriented therapies for patients with immunologic, hematologic, and other complex diseases. There will be two main drivers of innovation in the newly-formed PDT R&D group: Translational Pharmaceutical Sciences and Precision Medicine.
The Strategist is responsible for developing, coordinating and implementing global CMC regulatory strategies for assigned programs. Specifically, the Strategist is responsible for providing strategic guidance to PDT product teams by defining and optimizing global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the US, EU and international markets. The role will serve as the liaison to and oversee the regulatory affairs CMC relationship with US, EU, and International Health Authorities for CMC issues pertaining to assigned PDT programs.
- Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant Takeda R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend Takeda PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets.
- Maintains optimal Regulatory Affairs CMC effectiveness for ongoing development and lifecycle management activities for assigned programs.
- Provides proactive guidance and regulatory strategies to support PDT product teams.
- Remains knowledgeable about current CMC regulations and guidances and interprets the global CMC regulatory environment to provide proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical regulatory plans. Proactively identifies and assesses regulatory and compliance risks associated with product development and life-cycle management activities.
- Creates high quality, compliant CMC regulatory documents (eg, Core Dossiers, CTAs, MAAs, NDS, Variations and other relevant regulatory CMC filings) within defined timelines as per Takeda PDT BU objectives.
- Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of CMC regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved Plasma-Derived Therapies globally.
- Proactively develops and fosters appropriate relationships with global regulatory agencies, especially the US Food and Drug Administration and international regulatory agencies to develop effective, professional relationships and advance a positive company image.
- In partnership with other relevant functions, assists in the conduct of regulatory agency inspections and compliance audits. Ensures compliance in all GRA PDT BU activities.
- Acts as an ambassador for the Takeda PDT BU Regulatory Affairs organization to influence and shape the external regulatory and policy environment.
Your Skills and Qualifications:
- Minimum of 2-6 years of experience in global drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities
- Minimum of 2-5 years in a Regulatory Affairs CMC role
- Global regulatory CMC experience preferred
- Advanced degree preferred, such as BS, MS, or PhD
- Experience in plasma-derived therapies or biologics a plus
- Demonstrated leadership skills and ability to inspire colleagues.
Knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities
Excellent interpersonal, communication, analytical, managerial, and organizational skills.
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.
We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.
Motivated employees must be remunerated appropriately! The minimum salary for this important and responsible position is € 4 527,78 gross per month (full time, collective wage agreement for the chemical industry). This is a director-level position so the actual remuneration package will be guided by your professional experience and your qualifications. We are looking forward to your application!
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