March 28, 2023 5:30 pm CDT

Senior Manager, Global Regulatory Affairs, Marketed Products

  • Freelance
  • Anywhere

Takeda Pharmaceutical

nn 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. nn nn nn nn n Job Description n nn nnAre you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as an Senior Manager, Global Regulatory Affairs, Marketed Products in our Cambridge office.nn nn nn nnHere, everyone matters and you will be a vital contributor to our inspiring, bold mission. As Senior Manager, Global Regulatory Affairs, Marketed Products working on the Research and Development team, you will be empowered to define, develop and lead global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects. A typical will include:nn nn nn nn POSITION OBJECTIVES: nn n nnDefines, develops and leads global strategies to maximize global regulatory success towards achievement of program objectives for complex and/or multiple projects.nn n n nnProvides strategic and tactical advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.nn n n nnIs a leader within Takeda and external to Takeda, contributing to cross-functional initiatives and influencing the field as applicable.nn n nn                            nn nn POSITION ACCOUNTABILITIES: nn n nnThe Senior Manager will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Label Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure the global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible. nn n n nnEnsures project team colleagues, line management, and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner.nn n n nnProactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.nn n n nnAccountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports or junior colleagues executing these tasks. The Senior Manager will lead highly complex submission types such as original NDA/BLAs.nn n n nnDirect point of contact with FDA, leads and manages FDA meetings. Manages direct reports or junior staff as needed.nn n n nnAccountable for working with regulatory regional leads, other functions and vendors to ensure global regulatory submissions are provided to local Takeda affiliates in compliance with local regulations and to maintain compliance for products.nn n n nnOversee vendor responsibility for regulatory activities and submissions related to projects within scope.nn n n nnParticipates with influence in departmental and cross-functional task-forces and initiatives.nn n n nnLead regulatory reviewer in due diligence for licensing opportunities.nn n n nnPartner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.nn n n nnMonitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.nn n n nnResponsible for demonstrating Takeda leadership behaviorsnn n nn nn nn EDUCATION, EXPERIENCE AND SKILLS: nn n nnBSc Degree, preferred.  BA accepted.nn n n nn8+ years of pharmaceutical industry experience.  This is inclusive of 6 years of regulatory experience or combination of 5+ years regulatory and/or related experience. nn n n nnPreferred experience in reviewing, authoring, or managing components of regulatory submissions. nn n n nnSolid working knowledge of drug development process and regulatory requirements.  Knowledge of FDA, EU, Canada, ROW and post-marketing a plus. nn n n nnUnderstand and interpret complex scientific issues across multiple projects as it related to regulatory requirements and strategy.nn n n nnUnderstands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate regulatory strategy.nn n n nnStrong oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.nn n n nnDemonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.nn n n nnMust work well with others and within global teams. nn n n nnAcceptable and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.nn n nn nn nn TRAVEL REQUIREMENTS: nn n nnWillingness to travel to various meetings, including overnight trips.nn n n nnRequires approximately up to 10-30% travelnn n nn nn nn Base Salary Range: $124,000 to $178,000 based on candidate professional experience level.  Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.    nn nn nn nnAbsent 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.nn nn nn nn WHAT TAKEDA CAN OFFER YOU: nn n nn401(k) with company match and Annual Retirement Contribution Plannn n n nnTuition reimbursementnn n n nnCompany match of charitable contributionsnn n n nnHealth & Wellness programs including onsite flu shots and health screeningsnn n n nnGenerous time off for vacation and the option to purchase additional vacation daysnn n n nnCommunity Outreach Programsnn n nn nn nn Empowering Our People to Shine nn nn nn nnLearn more at .nn nn nn nn No Phone Calls or Recruiters Please. nn nn nn nn #LI-KD1 nn nn nn nIn accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.n nn nn nn EEO Statement nn nn 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. nn nn n Locations n nnBoston, MA nn nn nn n Worker Type n nnEmployee nn n Worker Sub-Type n nnRegularnn nn n Time T




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