Regulatory Compliance Regulatory Intelligence Manager (f/m/x)
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
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Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2019.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Regulatory Compliance Regulatory Intelligence Manager (f/m/x)Apply Now
- 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.
Job ID SR0040689