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Director, Regulatory Affairs

Norwood, MA

Posted: 01/22/2019 Job Category: Clinical: Regulatory Job Number: 2247

The Director, Regulatory Affairs will be responsible for leading the overall day-to-day operations of Regulatory Affairs.  Managing up to four individuals within the Regulatory Affairs group, this person will also participate in the development and implementation of registration strategies for each of the development programs underway. Routine interaction with relevant drug development groups to ensure regulatory implications are accounted for during development is expected as well as routine interactions with senior management to provide regulatory input on drug development programs.  Additionally, this person will be responsible for ensuring timely and compliant submissions to the various Health Authorities regulating the conduct of development programs.  This is considered a strong leadership role with the ability to act with a minimum of supervision with opportunity for advancement to the right individual.

PRIMARY RESPONSIBILITIES:
  • Provide leadership in implementing registration strategy across relevant groups, including Clinical Development, Preclinical Development, Marketing and CMC.
  • Directly supervise up to four direct reports
  • Lead and work closely with relevant clinical development personnel to ensure regulatory compliance and consistency with regulatory registration strategy
  • Manage interactions and build positive relationships with all relevant Health Authorities to facilitate timely and compliant submissions and approvals
  • Work closely with consultants and contractors to coordinate publishing, and other submission activities including eCTD preparation
  • Advise senior management on regulatory pathways and options
  • Regulatory document generation, as needed, as well as review and approve relevant documents
  • Review advertising and promotional materials as well as relevant media materials for regulatory compliance
  • Manage and grow Regulatory function as needed

SKILLS & REQUIREMENTS:
  • BS degree in appropriate field with 7+ years experience in bio-pharma and/or CRO
  • Thorough understanding of U.S. and Euro regulatory requirements, and the operating characteristics of regulatory agencies and their staff.
  • Experience in developing or assisting the regulatory strategy throughout all stages of drug development from pre-IND to market approval
  • Familiarity with special status such as orphan, fast track and breakthrough designations
  • RAPS Certification a plus
  • Successful history of managing direct reports as well as indirectly through others

 

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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