The Regulatory CMC Manager will be in charge of directing and managing Regulatory Affairs activities for developing global CMC strategies across product life cycles with a clear focus on providing collaborative support for execution of global strategies for the Plasma-Derived Therapies portfolio.
The PDT 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 and is providing significant investment into this area.
The major field of responsibilities embraces:
- Proactively contribute to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant Company R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend Company PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets
- Collaborate with regulatory colleagues in Global Regulatory Affairs (GRA) to ensure global perspective and support in the preparation of global regulatory documentation in a timely manner
- Lead the preparation and filing of CMC sections of regulatory submissions and interactions with regulatory agencies
- Develop global CMC regulatory strategy for one or more investigational and marketed products
- Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
- Participate in developing global CMC regulatory strategies
- Review and approve technical documentation including technology transfer protocols, validation protocols, technical reports, manufacturing and labeling information to assure conformance with regulations; and regulatory guidelines
- Significant coordination with cross-functional teams working mainly with internal customers, including QA, Technical Operations, other GRA Personnel, Pharmaceutical Sciences, Clinical Operations and occasionally works with CRO’s and regulatory agencies
Major requirements to cover this role:
- Bachelor´s degree in pharmacy, biochemistry, chemistry , biology or related pharmaceutical field
- Considerable experience within the pharmaceutical industry in CMC regulatory affairs, at least 3
- In-depth know-how of major market and ICH guidelines relevant to CMC aspects of product development and maintenance
- Relevant CMC regulatory experience in biologics, recombinant and/or small molecule regulatory activities
- Excellent collaboration, influencing and negotiation skills with the ability to establish and maintain collaborative working relationships internally and external with third party personnel
- Very structured working style, ensuring timely submission of appropriate regulatory documents in conjunction with regulatory operations
- Ability to set priorities and manage challenging assignments through collaboration, communication and teamwork
- Experience in directing interactions with regulatory authorities
- Ability to manage complex projects, timelines and teams in a matrix team environment
- Excellent analytical and communication skills – both verbal and written - in English; knowledge of German would be an asset
- Although there will be only limited scope for International travel for this role, the ability to undertake International travel will be preferred
Als weltweit führendes biopharmazeutisches Unternehmen mit der Mission „Better Health, Brighter Future“ stellen wir uns tagtäglich in den Dienst des Patienten. Unser Herzstück sind engagierte Kollegen – Takeda fördert uns durch Trainings, Job Rotations und Mentoring. Eine ausgeglichene Work-Life-Balance (Auszeichnung für Beruf & Familie, Betriebskindergarten) und zahlreiche Benefits (Fitness-Center, Kantine, etc) runden unser Profil als Top-Arbeitgeber ab.
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Motivierte Mitarbeiter gehören entsprechend entlohnt. Für diese wichtige und verantwortungsvolle Position beträgt das Mindestgehalt € 4.369,11 brutto/Monat (Vollzeit, KV chem. Industrie). Das tatsächliche Gehaltspaket richtet sich nach Ihrer Berufserfahrung und Qualifikation.
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