Your (new) Opportunity:
- Authoring of product risk assessments for synthetic- or biological products (finished and API) in commercial lifecycle and in development to meet local/global Health Authority guidelines.
- Review product risk assessments (technical- and quality-aspects).
- Partner with various functions in- and outside of Takeda to gather the information needed for authoring product risk assessments.
- Independently define CMC content (data and documentation) requirements for regulatory submissions and reviews this content for conformance with established requirement.
- Interact indirectly with international Health Authorities, as required.
- Ensure 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.
- Foster constructive working relationships when interacting with internal and/or external colleagues.
Your Skills and Qualifications:
- Min. BS/BA Degree in a Scientific discipline, advanced degree preferred.
- +5 years pharmaceutical experience, including experience in GRA CMC, Pharmaceutical Development, Analytical Development, Production, or Quality Assurance.
- Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
- Self-motivated and self-organized in execution of work.
- Ability to efficiently communicate with persons from various functions in- and outside of Takeda.
- Experience in working in global teams (= remote collaboration across time zones and geographies) preferred.
- Able to deal with issues of critical importance with minimal supervision.
- Demonstrates emerging leadership, problem-solving ability, flexibility and values teamwork.
- Exercises good judgement in elevating and communicating actual or potential risks/issues to line management.
- Excellent English written and oral communication skills.
- Experience with active participation in Industry groups/forums is a plus.
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 € 3.323,20 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.