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Global Regulatory Team Lead

Waltham MA, Bridgewater NJ
Job Order: GD-702

Global Regulatory Team Lead, Rare Blood Disorders

 

Job Descriptions:

  • This position is responsible for directing multiple innovative global regulatory strategies for product development and approval and commercial support. Responsible for defining strategies for meeting and while post approval compliance.
  • Responsible for regulatory documents, submissions, and compliance issues.
  • Represent the company with domestic and international regulatory authorities, contractors and corporate partners. Provide regulatory guidance for various corporate wide teams/committees.
  • Develops the global regulatory strategy for assigned programs through collaboration with a cross functional team
  • Advises project teams regarding the development and implementation of regulatory strategy. Maintains awareness of the changing regulatory landscape and advises team on changes that could impact future development.
  • Develops innovative life cycle management plans to achieve business objectives
  • Direct the organization and preparation of clear and effective submissions.
  • Establishes and maintains relationships with regulatory agency personnel.  Negotiates directly with regulatory authorities regarding company's filings.
  • Serves as regulatory affairs executive to provide input on trials and filing activities and to ensure that report systems are maintained and compliant.
  • Collaborates with other departments as well as corporate or marketing partners and outsourcing partners to achieve project goals.
  • Monitors regulatory publications to keep apprised of new or changing regulatory developments and potential strategic impact.
  • Reviews all external materials for regulatory compliance.
  • Represent Regulatory Affairs on cross-functional project teams
  • Effectively communicate the regulatory strategy, risks, mitigations and overall plans to the internal management teams as well as the executive management team.
  • Prepare and deliver effective presentations for external and internal audiences.
  • May be responsible for line management and development of direct reports.
  • Identify areas in need of improvement and lead the development and implementation of process improvements.
  • Create an environment conducive to a global view as part of the whole regulatory team.
  • Take steps to actively improve interdepartmental communications and efficiency.
  • Actively participate in and contribute to outside relevant conferences, including organizing and delivering presentations.
  • May have presence on external regulatory committees/trade associations.
  • Interacts with multiple departments at all levels.
  • Interact with a wide variety of outside contacts, including contractors, corporate partners and regulatory agency personnel.

 

Job Requirements:

  • 10 plus years pharmaceutical/biotechnology industry including extensive hands on global biologics strategy experience.
  • Minimum of 5-7 years in RA.
  • Comprehensive knowledge of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Extensive experience working on products in development specifically relating to clinical and pre-clinical regulatory aspects of the project.
  • Comprehensive knowledge of GCPs and GLPs.
  • Extensive experience in interfacing with regulatory authorities.
  • Ability to lead and influence project teams, committees, etc. to attain group goals.
  • Demonstrated leadership and communication skills.
  • Ability to represent the department in project teams, committees and external meetings.
  • Demonstrate strong organizational skills, including the ability to prioritize personal workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Well organized, detail oriented, effective written and oral communication skills.
  • Ability to guide, train, supervise and prioritize workload of direct reports, as required.
  • International regulatory experience preferred.
  • Experience in the development of therapies for rare (orphan) and/or extremely rare (ultra-orphan) diseases desirable.
  • BA/BS/University degree required, Life/Health Sciences preferred.
  • Doctoral degree in the sciences, Pharmacy or Regulatory Science preferred
DATE POSTED 2019-10-31

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