Director/Associate Director, Integration and Divestment Regulatory Affairs

Company: Takeda Pharmaceuticals
Location: Saint Paul
Posted on: September 22, 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 Takedas 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 DescriptionAbout the role:At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.The divestment of non-core assets, optimization of legal entities and acquisition of assets are critical parts of Takeda's overall business strategy to simplify our portfolio, invest back into our business, and innovate for patients. Join Takeda as a Director/Associate Director Integration and Divestment Regulatory Affairs where you will lead workstreams, as assigned, considering relevant non-clinical, clinical, labeling, RA-CMC and other regulatory strategies to ensure efficient and compliant execution resulting from an asset transactions. You will be responsible for comprehensive planning and submitting to regulatory authorities the appropriate documentation to transfer INDs, NDA, BLAs, MAAs, Orphan Drug Designations, PIPs, etc. As part of the R&D Divestment Office, you will report to the Senior Director, Integration and Divestment Regulatory Affairs and collaborate with regulatory team members including regulatory CROs or contractors and partner with other R&D functions (clinical operations, pharmacovigilance, program management, finance, IT) and other Takeda business units (Quality, Supply Chain, GMS, Global BD, Commercial and Legal).How you will contribute:

• Oversight lead for processes associated with divestment regulatory activities from the initiation of a deal until marketing authorization transfers complete. This includes ensuring consistent ways of working, addressing challenges that may arise across more than one transaction, and understanding and communicating the impact divested assets may have on various Takeda functions.
• Lead a workstream(s) transitioning regulatory assets or regulatory responsibilities to, from and within Takeda. This includes supporting inquiries and answering questions from our stakeholders during the exploration phase, leading RA kickoff and subsequent workstream meetings with our regulatory professionals, gaining alignment on the regulatory transfer strategy / timing, and ensuring Takeda's regulatory activities are completed to finish the transition all whilst keeping compliance with regulations and Takeda's SOPs.
• Collaborate with Takeda global, regional and LOC RA colleagues and regulatory CROs on asset transfer plans and timelines. This includes understanding planned and ongoing amendments/variations that may impact execution of regulatory asset transition(s) in impacted countries.
• Leverage existing regulatory intelligence to confirm all country-specific and region-specific requirements to support relevant regulatory transition activities.
• Review key transaction documents to ensure these documents reflect the regulatory transition services that Takeda may provide or will be provided by an external party.
• If transfer of regulatory documentation is required, engage in data transfer process examining both electronic and paper records in accordance with Takeda's record retention policies.Minimum Requirements/Qualifications:
  • Education:
  • Bachelor's Degree in science or business-related field preferred, BA will be considered
  • Advanced Degree in science or business preferred
  • Experience:
  • At least 10 years of pharmaceutical and/or biotech industry experience
  • At least 7 years of regulatory affairs experience or related experience in a multi-disciplinary, global environment
  • Experience working on multiple projects in a complex, ambiguous, fast-paced environment
  • Prior experience supporting acquisitions or divestments strongly preferred
  • Direct experience with marketed products outside the US (e.g. Europe and Growth and Emerging Markets) strongly preferred
  • Competencies and Skills:
  • Work with integrity
  • Strong negotiating and influencing skills
  • Understand and interpret complex issues across multiple projects as it relates to regulatory requirements and strategy for assigned projects. Provide knowledge and expertise to guide team in establishing and building appropriate regulatory strategies.
  • Understand broad concepts within regulatory affairs and implications across the organization and globally; proactively identify regulatory issues; offer creative solutions and strategies, including risk mitigation strategies.
  • Demonstrated ability to prepare and present clear and concise presentations for management
  • Lead teams to adapt to changing priorities, timelines, and external events
  • Inspire, motivate and collaborate within a virtual team setting across multiple time zones using various collaboration tools (MS Teams, Sharepoint, etc.) to achieve common objectives
  • Knowledge of clinical, CMC and post-marketing guidelines and regulatory requirements for key agencies including FDA, EMA, and international markets
  • Interpret regulatory documentation and information management system output
  • Oversight of the operational aspects of the project conducted by a regulatory CRO(s)
  • Ability to manage multiple projects and competing priorities to adhere to timelines
  • Drive decision-making within a cross-functional, cross-cultural global team structure
  • Resolve conflicts using creativity, flexibility and diplomacy
  • Fluent in EnglishWhat Takeda can offer you:
    • 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 Work Paths
    • Tuition reimbursementMore about us:At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.This position is currently classified as "remote" in accordance with Takeda's Hybrid and Remote Work policy.Base Salary Range: $185K to $ 215K, 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. This posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. 8-5-101 et seq#LI-LC1EEO 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.LocationsMassachusetts - VirtualWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time#LI-Remote

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