Sr. Manager Author, Pdt Global Regulatory Affairs

at Takeda Pharmaceuticals in Boise, Idaho, United States

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

ABOUT PLASMA-DERIVED THERAPIES

As a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda's Plasma-Derived Therapies Business Unit is dedicated to transforming the lives of patients worldwide who rely on these lifesaving and life-sustaining therapies.

With an 80-year legacy of developing treatments for rare and complex chronic diseases, we thrive on innovation, offering a broad, differentiated portfolio of more than 20 plasma medicines with integrated care solutions to patients in more than 80 countries.

Powered by 17,000+ Takeda employees primarily focused on plasma, our > 200 high-quality BioLife donation centers, a dedicated R&D team, and eight world-class plasma manufacturing facilities, we are unleashing data, digital and technology to transform our end-to-end operations and set new industry standards.

This enables us to meet innovatively and sustainably the growing and changing needs of patients, our people, and our planet, today and in the future.

THE OPPORTUNITY

The position of Sr. Manager Author, PDT Global Regulatory Affairs is a vital role within Takeda's Plasma-Derived Therapies Function. We are seeking a highly motivated and qualified regulatory CMC author/writer for the Global Regulatory Affairs CMC & Device organization in the Plasma-Derived Therapies Business Unit at Takeda.

This role is responsible for global CMC regulatory strategies and activities for the PDT BU product portfolio through clinical development, market launch, and product lifecycle management. Part of this role's scope is to oversee the day-to-day activities of a team of CMC submission authors, and work in a highly matrixed, global product team-oriented environment. This role will closely collaborate within the Global Regulatory Affairs CMC & Device organization, with other PDT BU functions, and relevant Takeda R&D functions to provide consistent and aligned regulatory CMC submission approaches globally, regionally, and locally.

Here you will help Takeda realize our ambition to transform the lives of patients through innovation and sustainability from plasma donation to delivery of medicines.

This is turn empowers Takeda's unwavering commitment to patients.

YOUR TASKS IN DETAIL

+ Oversees and manages the day-to-day activities of a team of CMC submission authors to assure the preparation of high quality and compliant Global Regulatory submission.

+ Maintains regulatory CMC dossier templates in alignment with current ICH and relevant regional regulatory requirements and standards.

+ Maintains a core source file management system to support all global plasma CMC submission activities.

+ Mentors a team of CMC submission authors on global submission requirements, standards, and formats.

+ Assures the effective collaboration between the CMC submission authors, Global Regulatory Affairs CMC Strategists, Global Manufacturing and Global Quality SMEs for the timely preparation and review of regulatory submission documentation.

+ Acts as liaison with relevant regulatory operations teams (e.g, Publishing)

+ Supports the development of efficient submission authoring and preparation procedures to assure timely completion of submission packages per business and regulatory timelines.

+ Helps maintain relevant submission-related systems and trackers and assures that global CMC regulatory submission documentation is consistent in terms of content and aligns with the global dossier templates.

+ Supports the overall department planning of CMC submission preparation and filing.

+ Identifies country-specific submission requirements.

+ Collaborates with Global Regulatory CMC Strategists to define detailed scope of submissions.

+ Coordinates document review sessions to collate comments and corrections of drafted documents and prepares the documents for final approval for timely submission.

REQUIRED QUALIFICATION, EXPERIENCE & SKILLS

+ Bachelor's degree in a scientific discipline (advanced degree preferred)

+ 5+ years of biotechnology/pharmaceutical industry experience

+ 3+ years of regulatory CMC experience (biologics or plasma preferred)

+ 2+ years of people management experience

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

+ Experience in reviewing, authoring and managing components of regulatory submissions

+ Excellent knowledge of Global Regulatory CMC requirements

+ Strong oral and written communication and negotiation skills

+ Highest level of compliance integrity and business adaptability

WHAT TAKEDA CAN OFFER YOU

For the fifth consecutive year, Takeda has been certified by the Top Employers Institute as a Global Top Employer. No investment we make pays greater dividends than taking good care of our people.

We offer you:

+ A meaningful career, grounded in our values (https://jobs.takeda.com/working-here)

+ Continuous professional growth and global careers

+ A diverse and inclusive network of colleagues

+ Comprehensive Healthcare: Medical, Dental, and Vision

+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan

+ Health & Wellness programs including onsite flu shots and health screenings

+ Generous time off for vacation and the option to purchase additional vacation days

+ Community Outreach Programs and company match of charitable contributions

+ Family Planning Support

+ Flexible Ways of Working

+ Tuition reimbursement

Diversity, Equity, and Inclusion

At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity, and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disability.

In accordance with the CO Equal Pay Act, Colorado applicants are not permitted to apply.

NEXT STEPS

Ready to apply? If you are interested in this opportunity, we look forward to receiving your application via our online tool!

Not yet? For further questions, please contact Claire Alonzo-Regis (Talent Acquisition Partner) via email: claire.alonzo@takeda.com

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.

Locations

Massachusetts - Virtual

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

\#LI-Remote