Your New Opportunity:
- Establish and implement corporate/global processes and procedures to drive compliance and efficiency across all regions. Ensure compliance and obtain, maintain and extend Takeda PDT BU product registrations in the United States, Japan, the European Union, Canada and Emerging Markets
- Develop and continuously improve process to ensure compliance and mitigate risk, identify supplemental procedures and training, as appropriate
- Oversee product labeling compliance, such as Company Core Data Sheet implementation; escalate and help resolve identified compliance issues, as appropriate
- Support internal audits and inspections by regulatory authorities and serve as the subject matter expert for GxP inspections by regulatory authorities. Provide support to LOC and regional regulatory affairs organizations and coordinates audit/inspection preparations as appropriate
- Coordinate responses to audit/inspection observations and findings
- Support completion and execution of CAPAs assigned up to CAPA closure
- Define regulatory reporting requirements at the regional and LOC level for risk communications (e.g. Dear Doctor Letters) and advises on reporting strategies
- Support monitoring commitments to regulatory authorities made for agreed risk communications and escalates in case commitments are delayed or cannot be fulfilled
- Support the execution of Field Corrective Actions
- Monitor overall compliance with regulatory reporting requirements, such as global annual reports, renewals, variations, safety variations, aggregate safety reports, PMC/PMR, etc. and escalates and helps resolve observed or projected delays in meeting commitments
- Member of the PDT BU Regulatory Affairs team supporting the future strategy of the Takeda PDT BU R&D and Global Regulatory Affairs organization, supporting BioLife International Regulatory Affairs activities as directed
Your Skills and Qualifications:
- Bachelor’s or Master’s degree, advanced scientific or health sciences degree or equivalent relevant experience preferred
- Minimum of 2 years in a regulatory affairs, compliance, pharmacovigilance or risk management role within a highly matrixed, GPT-oriented environment
- Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU and international markets
- Expertise in US and International regulatory affairs and global regulatory or health policy experience preferable
- Use precedent and previous experience to develop innovative and flexible approaches to ensure regulatory compliance
- Challenge self and others to overcome barriers and deliver high quality solutions to the business
- Profound knowledge of how to negotiate and influence without authority in a matrix environment
- Crisp decision-making following appropriate consultation, even in times of ambiguity
- Must be able to work in a fast paced, highly matrixed, GPT-oriented work environment with demonstrated ability to prioritize and complete multiple competing tasks and demands
- Excellent interpersonal communication (German/English) and analytical skills
- Flexibility for national and international travel anticipated
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 € 4.439,- 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.