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Manager - Licensing, Regulatory Affairs (remote nationwide)

Springfield, Illinois

Overview

Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.

Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.

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Success

What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.

  • Agile
  • Ambitious
  • Analytical
  • Collaborative
  • Enthusiastic
  • Entrepreneurial

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Opportunity

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

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

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

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

  • Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.

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

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Manager - Licensing, Regulatory Affairs (remote nationwide)

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Job ID SR0043058 Date posted 10/21/2019 Location Springfield, Illinois

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

A subsidiary of Takeda, BioLife is an industry leader in operating high quality plasmapheresis centers throughout the United States. At BioLife Plasma Services, we excel at caring. Caring for the quality of our lifesaving services, caring for the donors who help make it happen, and caring for the communities we call home. Improving Lives. Improving life for everyone.

BioLife’s employment opportunities are among the best, offering competitive pay, immediate benefits, paid time off, on the job training, advancement potential AND an environment full of fast-paced fun all while working to save lives.

OBJECTIVES/PURPOSE

  • Responsible for operational regulatory oversight of licensing/certification of all BioLife Plasma Services’ facilities by ensuring compliance to general standards and regulatory requirements. 

ACCOUNTABILITIES

Facility Support (50%)

  • Coordinate regulatory activities relating to licensing/certification for compliance to general standards of regulatory requirements as stated in the U.S. Code of Federal Regulations (e.g., FDA PAI) and corresponding requirements worldwide (e.g., AGES, KFDA, etc.) specific to plasma.
  • Provide support (on-sight or distance) for BioLife facilities (collection centers, labs, warehouses and headquarters) during health authority (e.g., FDA, EMA, etc.) inspections.

Administrative Support (30%)

  • Identify and Maintain a list of inspection participants.  Perform scheduling of support as needed.
  • Identify and maintain a list of subject matter experts in support of on-site regulatory inspections.
  • Prepare inspection audit schedule (e.g., AGES) and work with administrative support for travel requirements
  • Coordinate any pre-inspection meetings or phone calls with regulatory authorities (e.g., FDA PAI)
  • Work with RA team to maintain new center project plans to include licensing requirements.
  • Coordinate response to address unique regulatory requirements or inspection issues prior to inspection
  • Maintain knowledge of US and global regulatory requirements for biologics specific to plasma

Facilitating/Coaching (20%)

  • Enhance and maintain appropriate communications and support with RA, QA, Operations, Medical Affairs, and other departments to assist in responding to on-site investigators.
  • Develop and implement a training program for inspection support participants and relevant subject matter experts.
  • Build relationships with key advocates, regulators, and internal/external stakeholders to ensure compaany positions are understood and given appropriate consideration.
  • Develop and maintain inspector profiles in support of inspection readiness.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

Bachelor’s degree or country equivalent in a related scientific discipline desired.  Broad plasma industry related experience a must.

ADDITIONAL INFORMATION

  • Excellent speaking and oral presentation skills a must.  Effective oral and written communication necessary.   
  • Strong capability to engage, communicate and work effectively with individuals of varying job levels, geographic locations and dispositions
  • Aptitude in using Risk Management for decision making and recommendation process.
  • Ability to identify compliance risk and escalate when necessary.
  • Ability to build strong relationships with strong technology application and analytical skills.
  • Working knowledge of applicable state/local laws and how those laws impact the facilities that are being supported.
  • Travel 50+%
  • Relocation to Bannockburn preferred but not required.

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.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

Job ID SR0043058

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