Lead, Plasma-Derived Therapies - Global Regulatory Affairs Device

Description

About the role :

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients.

By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

Join Takeda as an Associate Director, Global Reg Affairs Device, PDT in our 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.

You will work in a highly matrixed, global product team-oriented environment and ensure 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.

Previous combination and drug delivery experience required for this role. The Geographic Scope for this role is Global

How you will contribute :

You will be responsible and accountable for :

Defining, coordinating and implementing global device regulatory strategies for device specific development and life-cycle activities

Providing proactive strategic guidance to the product-specific global regulatory and device development sub-teams for defining global regulatory device strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the medical, ancillary, or combination device in the United States and international markets

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., Q-Submissions, PMAs, De Novo filings, 510(k)s, EU Technical Docs, 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.

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.

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 teams to 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.

DIMENSIONS AND ASPECTS

The role requires an extensive experience in global pharmaceutical / biotechnological drug development and proven knowledge of the global regulatory CMC environment

Extensive experience in authoring and managing components of regulatory submissions

Leadership

Demonstrates strategic enterprise thinking finding innovative ways to serve patients, and build trust, reputation and business

Creates the environment that inspires and enables people to move the organization forward

Focuses on the few priorities and delivers superior results

Proven skills as an effective collaborator who can engender credibility and confidence within and outside the organization.

Global perspective with a demonstrated ability to work across functions, regions, and cultures.

Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization

Decision-Making and Autonomy

Accountable for acting decisively and exercise sound judgment in making decisions with limited information.

Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.

Develops executable plans and meets deadlines.

Builds a culture of data driven decisions.

Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution.

Ability to negotiate and influence without authority in a matrix environment.

Interaction

Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU.

Strong communicator, able to persuasively convey ideas verbally and in writing.

Innovation

Continuously challenging the status quo and bringing forward innovative solutions.

Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity

Delivers solutions to abstract problems across functional areas of the business.

Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.

Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through exceptional influencing skills.

Minimum Requirements / Qualifications :

Bachelor’s degree in a scientific or engineering discipline (advanced degree preferred)

8+ years of biotechnology, pharmaceutical or medical device industry experience

5+ years of regulatory device experience

Demonstrated ability to collaborate within teams and with key cross functional areas

Extensive experience in authoring and managing components of regulatory submissions including EU MDR TDs.

Excellent knowledge of global regulatory device requirements and experience with interactions / negotiations with global health authorities

Strong oral and written communication and negotiation skills

Highest level of compliance integrity and business adaptability

More about us :

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.

We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location : Cambridge, MA

Cambridge, MA

U.S. Base Salary Range :

$149,100.00 - $234,300.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and / or from which they will be performing the job.

The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

U.S. based employees may be eligible for short-term and / or long-termincentives. U.S.based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others.

U.S.based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.

EEO Statement

Locations

Cambridge, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time