Radius Health, Inc.

Director, CMC Regulatory Device

US-MA-Waltham | US-NJ-Parsippany
2 months ago
Job ID
2017-1635
# of Openings
1
Category
Pharmaceutical Sciences

Overview

The Director, CMC Regulatory Device will develop and implement Global Regulatory and from development through marketing approval for the US, EU and other markets. The incumbent will be responsible for regulatory leadership, preparation and support of US IND and NDA regulatory submissions, and ensuring compliance to all applicable regulations and standards, with focus on the device component of submissions and on specific drug/device combination product requirements. Chemistry, Manufacturing and Control (CMC) Regulatory strategies for drug/device combination products

Responsibilities

  • Prepares and manages CMC Regulatory content for submissions in all applicable regions, ensuring high quality and timely submissions.
    • Submissions may include INDs, MAAs / NDAs - Module 3 and QOS content, supplemental submissions and responses to health authority questions, in support of drug product or drug/device combination product development or commercialization.
    • Supported activities may include API development and validation, DP and/or drug/device combination product development, validation and commercialization, Design Control strategy and documentation, and Human Factors validation testing. 
  • Is a member of and serves as a CMC Regulatory and Combination Product Subject Matter Expert to Project teams and/or CMC sub-teams
  • Leads regulatory strategy for all activities with Regulatory impact for assigned projects, creating and maintaining CMC Regulatory strategy documents
  • In concert with Regulatory Operations, ensures completeness and timeliness of CMC submissions, including through creation and maintenance of associated tracking systems.
  • Assures that procedures are maintained and followed for archiving of appropriate records and regulatory documentation, including agency contact records, regulatory filing records, etc.
  • Maintains expert knowledge in US and international pharmaceutical and combination product regulations and provides proactive regulatory intelligence, particularly in quickly changing and/or highly competitive areas, in all relevant territories (e.g. US, EU, JP, ICH).
  • Develops or contributes to and maintain SOPs with an emphasis on adhering to drug and device regulations and delivering high quality solutions to our patients.

Qualifications

  • Minimum of BS in life sciences, engineering, or equivalent required.
  • RAC certification and/or other regulatory certification is a plus
  • 8+ years in the pharmaceutical industry, including both oral drug and drug/device combination product development and commercialization experience.
  • Experience in developing and submitting successful IND/NDA submissions with a thorough understanding of the drug development process, FDA regulations and ICH guidelines, with demonstrated expertise in combination products.

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