To further strengthen and extend the local team, we are looking for a Global Regulatory Affairs Compliance and Process Excellence Lead (f/m/d) for our client Takeda in Vienna´s 22 district. We are looking for a dynamic and communicative team player who is willing to take this unique challenge in a successful international company.
Global Regulatory Affairs Compliance and Process Excellence Lead (f/m/d)
Plasma-Derived Therapies Business Unit
The PDT BU R&D group 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.
- In partnership with others and under the direction of the Head, Global Regulatory Affairs Compliance and Process Excellence, PDT BU, establishes and implements processes and procedures to drive compliance and efficiency across all regions in close collaboration with relevant , PDT BU R&D, Takeda R&D, Quality Assurance, GMS, GDS, Medical Affairs, Legal and Commercial functions
- Supports monitoring of the implementation of corporate/global processes and procedures at the PDT BU GRA level and identifying supplemental procedures and training, as appropriate
- Helps develop and continuously improve process within the PTD BU to ensure compliance and mitigate risk
- Supports Takeda internal audits and inspections by regulatory authorities for PDT BU products. Together with the Head, Global Regulatory Affairs Compliance and Process Excellence, PDT BU serves as the PDT BU GRA subject matter expert for GxP inspections by regulatory authorities
- Helps coordinate responses to audit/inspection observations and findings linked to PDT BU GRA and supports completion and execution of CAPAs assigned to PDT BU GRA up to CAPA closure
- Helps define regulatory reporting requirements at the regional and LOC level for risk communications (e.g. Dear Doctor Letters) and advises on reporting strategies.
- Monitors overall compliance with regulatory reporting requirements, such as global annual reports, renewals, variations, safety variations, aggregate safety reports
- Bachelor's or Master's degree required. Advanced scientific or health sciences degree or equivalent relevant experience
- Minimum of 2 years professional experience in a regulatory affairs, compliance, pharmacovigilance or risk management role
- US and International regulatory affairs and global regulatory or health policy experience preferable
- Ability to use precedent and previous experience to develop innovative and flexible approaches to ensure regulatory compliance
- Ability to challenge self and others to overcome barriers and deliver high quality solutions to the business.
- Ability to negotiate and influence without authority in a matrix environment.
- Crisp decision-making following appropriate consultation, even in times of ambiguity.
- Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU and international markets.
- 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 and analytical skills
- Ability to embrace change, challenge the status quo and drive improvements to processes and products
- Fluency in English and German
- Team player, good business acumen
- ~10-20% national and international travel anticipated
Remuneration corresponds to the respective classification according to the collective agreement for the chemical industry. The minimum salary for this position is € 4.369,11 gross per month based on full-time employment. Possible increased payment is dependent on professional experience and/or qualifications. In the first step, the contract will be limited to one year.
In addition Takeda offers many social benefits (e.g. canteen, wellness-center) to mention just a few of them.
Please note that your complete application documents including all personal data will be forwarded to Takeda in order to perform the selection procedure.