- Global leadership and primary accountability for design and sustainability of overall Regulatory Intelligence strategies and processes for Takeda
- Responsible for the establishment and day to day operations of Regulatory Intelligence for Takeda and communication of any trends or concerns to our senior leadership
- Develop and lead efforts to establish integrated and sustainable Regulatory Intelligence strategies, processes, and activities for our products (clincial and commercial) enabling a sustainable existence on the market
- Define and implement a collaborative process with GMSGQ functions and other Takeda Business functions and stakeholders to execute regulatory intelligence (RI) strategies including but not limited to integrated processes for all OpUs and Regions, R&D processes, Governance Forums, and support due diligence evaluations for RI for the integration of Takeda acquisitions
- Establishes the operational objectives and assignments for the Regulatory Intelligence team
- Drive progress on cross functional projects related to regulatory intelligence
Your Skills and Qualifications
- Scientific or engineering graduate (BSc, MSc, PhD), preferably complemented by economic education (MBA)
- At least 8 years managerial experience and responsibility combined with strong technical operations background
- Proven success in managing global change by influence - without direct resource control with a strong focus on delivering global results as well as building capability to demonstrate effective governance
- Strong scientific as well as technical expertise to ensure robust analysis of complex product data and the ability to assess that information to make scientifically sound quality risk-based recommendations
- Working knowledge of Regulations, US and EU Regulations, including cGMPs and GDPs, including knowledge of controlled substance standards accommodating for example, DEA, IMB, Med Devices, OTCs, etc.
- Solid understanding of the pharmaceutical industry - proven experience in pharmaceutical manufacturing support and governance at a site level
- Knowledge and experience in bio-pharmaceutical technology
- Profound knowledge and experiences with Quality Management and systems in a regulated industry
- Structured in communication and presentation to senior management
- Well-organized logical thinking personality with a goal-oriented, time line driven, and dynamic work attitude
- Strong leadership and effective interpersonal skills particularly motivational, negotiation, listening, judgement and conflict management skills as is demonstrated in a matrix global environment
- Excellent organization, written, and verbal skills to convey global project goals and inspire support from both subordinates and senior management
- Fluent in written and spoken English
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.
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 € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.