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Regulatory Affairs CMC Director for Plasma-Derived Therapies (f/m/x)

Regulatory Affairs CMC Director for Plasma-Derived Therapies (f/m/x)

Apply NowEmail Me Job ID SR0056758 Date posted 02/18/2021 Location: Baden bei Wien, Austria

The R&D organization of the Plasma-Derived Therapies Business Unit (PDT BU) 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. There will be two main drivers of innovation in this newly-formed PDT R&D group: Translational Pharmaceutical Sciences and Precision Medicine.

The Team Lead is responsible for providing proactive leadership and strategic guidance to a team of Regulatory Affairs CMC Strategists by developing and implementing global regulatory strategies pertaining to the development, registration, commercialization and lifecycle management of Plasma-Derived Therapies in the United States and international markets. The role will serve as the liaison to and oversee the regulatory affairs relationship with US and International Health Authorities for CMC issues pertaining to the Team Lead's assigned product portfolio, as well as with relevant Takeda business stakeholders.

Your Opportunity:
* Proactively contribute to the development and implementation of innovative CMC regulatory strategies
* Closely collaborate with relevant Takeda R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend Takeda PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets
* Maintain optimal Regulatory Affairs CMC effectiveness for ongoing development and lifecycle management activities
* Remain knowledgeable about current CMC regulations and guidance and interprets the global CMC regulatory environment to provide proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical regulatory plans
* Identify and assess regulatory and compliance risks associated with product development and life-cycle management activities
* In partnership with other relevant functions, assist in the conduct of regulatory agency inspections and compliance audits
* Serve as an active member of the Regulatory Affairs CMC & Device leadership team to help influence and execute the operations and future strategy of the Takeda PDT BU R&D and Global Regulatory Affairs organization
* Work in a highly matrixed, Global Product Team-oriented environment and ensures close collaboration with other PDT BU functions and relevant Takeda R&D functions to provide an effective, common approach and partnership centrally, regionally, and locally
* Achieves regulatory and operational excellence within the team
* Guide, coach and develop a highly-competent team of Regulatory Affairs CMC Strategists; recruit top talent

Your Skills and Qualifications:
* Minimum of 12 years of experience in global drug/biologics development in the biopharmaceutical or biotechnology industry, or Government Health Authorities, including at least 6 years in a Regulatory Affairs CMC role and 4 years in a leadership role
* Knowledge of the global drug discovery and development process, laws and CMC and/or device regulations affecting biopharmaceutical development in US, EU and international markets.
* Experience in plasma-derived therapies or biologics preferred
* Global regulatory CMC experience preferred
* Advanced scientific degree preferred (e.g., PhD, MD or JD)
* Extensive knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with global Regulatory Authorities.
* Ability to use precedent and previous experience to develop innovative and flexible approaches to achieving commercial goals.
* Crisp decision-making following appropriate consultation, even in times of ambiguity.
* Demonstrated leadership skills and ability to inspire colleagues.
* Crisp decision-making following appropriate consultation, even in times of ambiguity.
* Ability to motivate, mentor and manage a diverse team in a matrix environment and to influence in a matrixed environment

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 € 4.439,- gross per month (full time, collective wage agreement for the chemical industry). This is a director-level position so the actual remuneration package will be guided by your professional experience and your qualifications. We are looking forward to your application!

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.

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Regulatory Affairs CMC Director for Plasma-Derived Therapies (f/m/x)



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