Regulatory Affairs Leader
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Regulatory Affairs Leader
Ref No.: 18-03310
Location: Waltham, Massachusetts
Position Type:Contract
Shift:First
Job Category:Biotech/Pharmaceutical
Benefits:Medical Insurance
Regulatory Affairs Leader

This is a 1 year contract role. 

Responsibilities:
  • Regulatory strategy management opportunity to for global biological clinical programs within the complement portfolio, including INDs and BLAs for orphan indications. This position will be responsible for leading and/or supporting global strategy and submissions.
  • Responsible for developing and implementing regulatory strategies, including filing of all appropriate regulatory submissions for assigned programs.
  • Responsible for leading or supporting Agency meetings.
  • Responsible for leading and coordinating all aspects of regulatory submissions relevant to assigned projects or programs
  • Identify and assess regulatory risks associated with product development for assigned programs. Assist in defining strategies to mitigate risks
  • Guide the organization and preparation of clear and effective submissions.
  • Ensures completion of high-quality submissions, adhering to regulatory guidelines, regional specifications, and company standards.
  • Monitor and analyze appropriate regulatory agency activities in areas of interest to the company. Assess impact on specific projects.
  • Function as assigned project team member.
Qualifications:
  • A minimum of 10 years in the Pharmaceutical Industry, and a minimum 5 years regulatory management experience (Biologics)
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
  • Demonstrate excellent communication skills.
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Demonstrate effective cross-cultural awareness and capabilities.
  • Some direct experience in interfacing with relevant regulatory authorities.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Excellent knowledge and understanding of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
Education:
  • BA/BS/University degree required, Life/Health Sciences preferred.