Manager Global Regulatory Affairs Device, PDT

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TAKEDA’S PLASMA-DERIVED THERAPIES BUSINESS UNIT:

Our ambition is to transform the lives of patients through innovation and sustainability from plasma donation to delivery of holistic Plasma-Derived Therapeutic solutions.

Takeda’s Plasma-Derived Therapies (PDT) Business Unit (BU) is fully dedicated to serving the needs of communities around the world who rely on plasma-derived therapies based on the therapeutic proteins in plasma.

One of the top three plasma organizations in the world, Takeda’s PDT BU is rethinking the entire plasma value chain to help ensure a more sustainable supply of these therapies today and for the future.

OBJECTIVES/PURPOSE

We are seeking a highly motivated and qualified medical device regulatory professional for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda. The Global Regulatory Affairs CMC & Device organization is responsible for global device regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch and product lifecycle management.

The Strategist works in a highly highly matrixed, global product team-oriented environment and ensures close collaboration within the Global Regulatory Affairs CMC & Device organization and with other PDT BU functions and relevant Takeda R&D functions to provide an effective and aligned regulatory device strategy and submission approach globally, regionally and locally.

Job Description / Role Profile

• The role liaises directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for device-related matters. Negotiates with regulatory authorities during the development process to ensure submission acceptance and approval.
• Manages the device regulatory strategy of high quality and compliant regulatory device documentation (e.g., BLAs, DHFs, Q-Submissions, PMAs, De Novo filings, 510(k)s, MAFs, EU Technical Files, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives.
• Advises on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with the business need and goals.
• Facilitates the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders.
• Identifies and recommends the most effective device regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations. o Proactively contributes to the development and implementation of innovative device regulatory strategies in close collaboration with relevant stakeholders or functions in line with Takeda’s operating model with the purpose to obtain, maintain and extend Takeda PDT BU product registrations in global markets. Provides proactive guidance and regulatory strategies to support PDT product teams.
• Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of regulatory device submissions as assigned to product and programs. o In collaboration with the network strategist, develops and manages timelines supporting regulatory submissions, proactively identifies risks and develops adequate risk management solutions in consultation with cross-functional teams.
• In collaboration with regional and local regulatory colleagues, critically evaluates device change controls to ensure all regulatory requirements to implement the change have been fully document in the respective quality management system.
• Provides tactical and strategic regulatory input and guidance, including active participation in problem solving analysis by assessing and proposing alternative solutions to issues and prepare contingency plans while still meeting regulations.
• Maintains an ongoing and interactive relationship with regional and local regulatory teamsto assure that all aspects of the company’s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
• Creates high quality, compliant regulatory device documents within defined timelines as per Takeda's PDT BU objectives.
• Participates in discussions and negotiations with regulatory authorities, agents, business partners, proactively and as required.
• Assists in the conduct of regulatory agency inspections and compliance audits.

EDUCATION AND EXPERIENCE REQUIREMENTS

• 5+ years of biotechnology, pharmaceutical or medical device industry experience
• 3+ years of regulatory device experience
• Demonstrated ability to collaborate within teams and with key cross functional areas
• Demonstrated experience in authoring and managing components of regulatory submissions
• FDA CDRH experience with 510K Submission
• Experience with stand Alone Devices Submission
• European CTA (Clinical Trial Applications) experience
• European Device CE Mark Technical Files/Technical Documentation experience
• Combination Product Experience a plus
• Bachelor’s degree in a scientific or engineering discipline

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.