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Senior Director Global Regulatory Affairs Oncology
Clinical Dynamix, Inc.
 
Job Location: Cambridge, MA

Job Description

The Global Regulatory Team Lead is part of the Global Regulatory Affairs (GRA) organization within the Global Business Unit (GBU). He/she is responsible for developing long and short-term regulatory strategies for the projects and products under his/her accountability. The GRTL is responsible for the development as well as life cycle management strategies for the assigned project/products.

Responsibilities

  • Represents GRA as a core member of the cross functional project team and Global Brand team and provides overall regulatory input for the project(s) globally. In this capacity, the GRTL is the single point of contact for the business on regulatory issues for the project(s).
  • The GRTL will ensure the development of robust global regulatory strategies, including Global Submission Strategy (GSS), for their assigned products and will be accountable for developing and maintaining a global regulatory product strategy document (GRPS)
  • The GRTL will work transversally to ensure a properly functional regulatory sub-team. The GRTL facilitates the development and implementation of local regulatory strategy working with the regulatory platforms, regions and/or the countries.
  • The GRTL is accountable to present the global regulatory strategy/position to senior management / governance committees as needed.
  • The GRTL will work with the labeling strategists and regional groups to ensure appropriate labeling content based on the clinical program and TPP. The GRTL will also work with the labeling strategist and regions to develop region specific labels.
  • The GRTL will ensure timely communications of relevant topics to the business and up through GRA senior Management. The communication of any HA feedback should be interpreted and the impact on the project assessed.
  • Research and analyse regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes
  • Ensure compliance with all internal and external requirements and procedures and may suggest improvement to operating policies/processes, as appropriate.
  • The GRTL may line manage, and/or coach mentor, junior staff supporting the program
  • Depending on the program assignment, the GRTL may also serve as the US Regulatory Lead.

Experience/ Professional Requirements

  • Direct interaction/negotiation with regulatory authorities (e.g. FDA, EMA)
  • Strong strategic skills including the ability to make complex decisions and willingness to defend difficult positions.
  • Solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy and guidance
  • Excellent operational skills including planning, organizing and ability to motivate and lead others.
  • Ability to work well within cross-functional teams
  • Can demonstrate solid oral communication and writing skills
  • Understanding of the Global (including US, EU in Japan in particular) and U.S. pharmaceutical market place and familiarity with medical terminology.
  • Develops collaborative relationships to facilitate the accomplishment of work goals
  • Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
  • Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
  • Can build networks to obtain cooperation without relying on authority
  • Strong sensitivity for a multicultural/multinational environment
  • Unquestionable ethics, professional integrity, and personal values consistent with the values

Education Requirements

  • Bachelor's degree and at least 5 years in Regulatory Affairs or relevant industry experience
  • Master’s, PharmD, PhD degree and at least 3 years in Regulatory Affairs or relevant industry experience
  • Education area of study in a scientific discipline/MS or Doctoral degree/Pharm D a plus.




How To Apply:
You will be directed to another website for application instructions.
 
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