Regulatory Affairs Operations Manager

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Regulatory Affairs Operations Manager

Cambridge, Massachusetts

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Business Area Overview

As a trusted global leader and industry partner who is reimagining plasma and exploring its untapped potential, Takeda’s Plasma-Derived Therapies (PDT) 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, 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 innovatively and sustainably meet the growing and changing needs of patients, our people, and our planet, today and in the future.

Success Profile

What makes a successful team member within PDT at Takeda?

  • Bold Thinker
  • Collaborator
  • Systematic
  • Agile
  • Innovative
  • Tenacious

At the iHUB, we focus on disruptive innovation within our PDT Donor to patient ecosystem that not only focuses on the patients of today, but creates the pathway to meet the patients of tomorrow.

Nat Arlander Head of the Plasma Innovation Hub in PDT

Our dedicated and specialized PDT R&D organization is uniquely positioned to support the entire patient experience. By challenging decades of established thinking and driving patient-centric innovations, we have the opportunity to have a tremendous impact on those who rely on plasma-derived therapies today and those who can benefit from them in the future.

Kristina Allikmets Head of PDT, R&D

Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.

  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.

  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.

  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 11 companies to receive Top Global Employer® status for 2022.

  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.

  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

Regulatory Affairs Operations Manager

Job ID R0071438 Date posted Aug. 10, 2022 Location Cambridge, Massachusetts

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’sPrivacy Noticeand 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

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? 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. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. 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. Here, you will be a vital contributor to our inspiring, bold mission.

OBJECTIVES/PURPOSE

The role of Regulatory Affairs Operations Manager will play a key role in supporting data analytics in the PDT Regulatory Affairs organisation.  This will include efforts to maintain tracking mechanisms, data gathering and analysis efforts, as well as producing reports and outputs for decision making.  Some tasks are administrative in nature.  This role requires liaison and coordination within the PDT BU, the broader Takeda organization as well as with outside vendors.

  • Provide regulatory operational support to confidential business projects

  • Maintaining tracking mechanisms including conducting internal data gathering and performing analysis activities

  • Vendor support activities such as resourcing, finance and budget support i.e. processing purchase orders, monthly accruals as well as coordinating with Legal and Procurement and some minor administrative tasks.

ACCOUNTABILITIES

  • Leads and/or provides direction to cross-functional projects including developing timelines and understanding the impact on processes and impacts for other disciplines.   -

  • Work independently providing RA communications activities such as PDT Monthly Regulatory Intelligence Newsletter, SharePoint sites, Product Assignment Lists, maintaining tracking mechanisms, training matrices and internal and external communication such as conducting internal data gathering and analysis activities.

  • Within area of accountability, navigate financial and legal disciplines to manage vendor contracts with third-party and embedded vendors as well as providing support for PDT GRA and PDT Finance activities such as PDUFA, regulatory fees and R&D tax incentives, US purchase orders and process invoices.

  • Within area of accountability, may represent organisation in vendor management activities to influence existing partnerships and alliances.

  • Acts as a point of contact and interface with key PDT BU, R&D functions as well as external partners as appropriate.

  • Work independently to coordinate RA European/US Leadership Team meetings and GRA events, create agenda’s, maintain minutes of meetings.

  • Create and drive deliverables as they pertain to the PDT Business Unit including PowerPoint presentations, Excel spreadsheets, SharePoint, Power BI, InterACT reports.

  • Be an active ambassador and driver for an engaging culture; build trust and productive relationships with team members and stakeholders across organization.

  • Represent PDT in voluntary, employee-led groups such as Takeda Resource Groups etc.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

  • Demonstrated administrational and project management experience

  • Project management skill base, power BI, excel, reporting capabilities

Leadership

  • Demonstrated ability to work across functions, regions and cultures.

  • Enterprise-level leadership with the ability to inspire, motivate and drive results.

  • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing.

  • Proven skills as an effective team player who can engender credibility and confidence within and outside the company.

  • Ability to distill complex issues and ideas down to simple comprehensible terms.

  • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization.

  • Excellent interpersonal skills and ability to interact cross-functionally.

Decision-making and Autonomy

  • Able to work independently and exercise judgment, within broadly defined practices, to evaluate data.

  • Leads and/or provides direction to cross-functional projects with significant complexity. 

Interaction

  • Ability to communicate with impact in a global, culturally diverse environment.

  • Excellent written and verbal skills to lead & motivate teams, frame actions and decisions and drive clarity among stakeholders.

  • Proven skills in negotiations, influencing in a matrix environment, leading through ambiguity and working diplomatically through conflict.

Innovation

  • Solves unique and complex problems with broad impact on the business.  Requires conceptual and innovative thinking to develop, new creative solutions.

  • Embraces risk as opportunity and willingness to try new approaches.

  • Visionary and forward thinking with the ability to influence and effectively drive organizational change and continuous innovation.

  • Comfortable challenging the status quo and bringing forward innovative solutions.

Complexity

  • Ability to work on issues in which analysis of information requires an evaluation of various factors.

  • Ability to rapidly synthesise information from multiple sources, communicate ideas and data both verbally and written in a persuasive and appropriate manner in multi-cultural environment.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

  • Bachelor’s degree

  • Experience and understanding of global regulatory submissions, including eCTD lifecycling for electronic dossier management and associated project management skills.

  • 5 years of work experience

  • 3+ years related experience in Regulatory Affairs or R&D environment

  • Locations preference- Cambridge, MA (Open to hybrid or remote if the candidate is willing to work in East Standard Time Zone)

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.

WHAT TAKEDA CAN OFFER YOU:

  • 401(k) with company match and Annual Retirement Contribution Plan
  • Tuition reimbursement Company match of charitable contributions
  • 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
  • Empowering Our People to Shine
  • Discover more at takedajobs.com

No Phone Calls or Recruiters Please.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.

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

USA - MA - Cambridge

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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