EvanstonRecruiter Since 2001
the smart solution for Evanston jobs

Regulatory Affairs Associate II

Company: Biolife Plasma Services
Location: Evanston
Posted on: September 15, 2022

Job Description:

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 DescriptionOBJECTIVESPURPOSEPrepare, submit, track and maintain new and existing facility licenseregistration applications to relevant authorities.Prepare and submit additional regulatory submissions or reportsServe as direct liaison with relevant health authorities under the supervision of direct manager.Represent regulatory on relevant project teams.ACCOUNTABILITIESPrepare and submit new facility licenseregistration applications to relevant authorities in the US (e.g., FDA, CLIA, State DOH, PPTA, etc).Track licenseregistration renewals.-- - Submit renewals timely to ensure continuity in maintaining current.Prepare and submit other regulatory submissions, applications, reports and notifications in a timely manner according to regulatory and company requirements.Document Control AdministrationReview, evaluate, and communicate new and revised regulations.Respond to regulatory agency (including BPD reports), field locations and corporate department requests when required.Administrative SupportDevelop and manage regulatory project plans.Maintain department metrics.Prepare, review, and approve procedures as requiredCollaborative Support (15%)Represent Regulatory Affairs in project teams; provide regulatory advice.Provide support, guidance, and coaching to other Regulatory Affairs team members.Provide classroom and virtual training on Regulatory topics as requiredDIMENSIONS AND ASPECTS TechnicalFunctional (Line) ExpertiseWorking knowledge of applicable US federal, state, and local laws and how those laws impact the facilities that are being supported.LeadershipAccountable and results-oriented.Ability to identify potential challenges and opportunities and make recommendations.Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization.Decision-making and AutonomyAccountable for acting decisively and exercise sound judgment in making decisions .Ability to incorporate feedback and ensure decisions are made swiftly to enable flawless teractionCustomer focus - willing to help, respectful, prompt, and accountable.Strong communication skills (written and oral).Team member with other departmentsfunctions as novationWorking knowledge of applicable US federal, state, and local laws and how those laws impact the facilities that are being supported.Ability to identify compliance risk and escalate when plexityDisciplined action and execution, ability to drive operational excellence, promote teamwork, and communicate effectively.Ability to provide data that will resolve or simplifies complexity between functional groups.EDUCATION AND EXPERIENCE REQUIREMENTSBachelor's degree requiredEEO 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.EEO StatementTakeda 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.LocationsBannockburn, ILWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time

Keywords: Biolife Plasma Services, Evanston , Regulatory Affairs Associate II, Other , Evanston, Illinois

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest Illinois jobs by following @recnetIL on Twitter!

Evanston RSS job feeds