Director (f/m/x), Regulatory Affairs CMC


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Objectives/Purpose:

  • The Director Regulatory Affairs CMC: oversees the development and execution of regulatory CMC development and registration strategies RA CMC member on Regulatory, Pharmaceutical Development, and Production project teams throughout clinical development and commercial lifecycle for assigned products and staff
  • Demonstrates high level of leadership and expert understanding of global RA CMC regulations and guidelines by applying interpersonal skills and expert RA CMC knowledge to address and overcome challenges that arise during development and commercialization
  • Manages and or mentors staff members, if required
  • Successfully communicated and negotiates with international Health Authorities as necessary, directly and indirectly
  • Provides regulatory CMC expertise for new business development due diligence activities
  • Proactively recognizes and contributes to enhancing business processes

Your Opportunities:

  • Taking responsibility of demonstrating Takeda leadership behaviors
  • Independently plan, execute, and manage regulatory submissions for assigned compounds in various phases of clinical development, global marketing applications, and post-approval life cycle activities
  • As member of global cross-functional teams which require experienced interpretation of applicable EMA/FDA/ICH/WHO/Global regulations, ensure CMC compliance within the organization
  • Lead team members that defines CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements
  • Lead and/or contribute to business process development and enhancement
  • Evaluate new business development opportunities or participate on due diligence teams
  • Develop and maintain constructive relations with key internal and external colleagues, eg cross functional colleagues within Takeda, Alliance Partners and Health Authority representatives
  • Stay responsible for ensuring that 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
  • Exercise good judgement in elevating and communicating actual or potential issues to line management
  • Successfully communicate and negotiate with international Health Authorities as necessary, directly and indirectly
  • Representing Takeda RA CMC in Health Authority meetings and leading or supporting CMC preparation activities for meetings with Health Authorities on CMC related matters
  • Interacting directly with international Health Authorities, as required
  • Manage and develop staff, if required, including staff professional development and project oversight accountability
  • Evaluate change proposals for regulatory impact and filing requirements

Your Skills and Qualifications:

  • BS/BA Degree in Scientific Discipline, advanced degree preferred
  • Extensive and profound pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience, with international experience strongly preferred
  • Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions and product development meetings, international experience preferred
  • Understanding scientific principles and regulatory CMC requirements relevant to global drug development and post-market support
  • Proven ability to provide strategic regulatory guidance to drug development, registration, and post-market support teams
  • Able to deal with issues of critical importance, providing regulatory advice and making reasoned decisions on regulatory issues for which there may not be clear/specific regulatory guidance
  • Strong leadership, problem-solving ability, flexibility and teamwork
  • Sound judgement in elevating and communicating actual or potential issues to line management
  • Excellent written and oral communication skills required
  • Active participation in Agency/Industry groups/forums expected
  • Willingness to travel approximately 10-30%

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. Takeda encourages and supports its employees by trainings, job rotations and mentoring. A balanced work - life ratio (recognition for work and family, company kindergarten) and numerous benefits (fitness center, cafeteria, etc.) complete our profile as a top employer. For more insights into Takeda click here.

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. Gender, age, skin color, background or sexual orientation play no role in this as we actively promote diversity. We equally address people with disabilities. In the course of a recruitment process which is as free of barriers as possible, we encourage you to mention all relevant information in this context in your application.

Motivated employees must be remunerated appropriately. The minimum salary for this important and responsible position is € 4.369,11 gross per month (full time, collective wage agreement for the chemical industry). The actual remuneration package will be guided by your professional experience and your qualifications, so increased payment is possible.

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.


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