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Associate Director

Location: Wayne, PA
Status: Full-time, Employee
*Local candidates preferred. Must be able to work unrestricted in US. No Agencies please.

Reporting directly to the Vice President of Regulatory Affairs, the Associate Director’s primary responsibilities will include the following:

  • Provide regulatory consulting for clients in order to assist them with the filings and approval processes for
  • IND, NDA, BLA and ANDA submissions and electronic (eCTD & eNDA/BLA) submissions of the previous mentioned
  • Conduct regulatory review of technical summaries, reports and administrative documents for regulatory filings
  • Assure submissions adhere to FDA/ICH regulations/guidelines
  • Provide internal training to Regulatory Operations group regarding Regulatory Issues including electronic submissions and CTD/eCTD
  • Serve as Regulatory Subject Matter Expert, as needed, in support of Process Consulting Group projects; includes consulting on FDA /Regulation Guidance interpretation, Electronic Submissions and Document
  • Authoring/Publishing Processes
  • Manage the schedule and quality of work of his or her direct reports, as well as provide continued
  • Serve as the regulatory liaison with the FDA, health authorities and other outside contacts

The successful candidate will have a combination of the following skills/experience:

  • Bachelors’ degree in biochemistry, chemistry, biology or related pharmaceutical field
  • 10 plus years of experience drug development and regulatory strategy experience
  • Must have strong content knowledge of US and global submissions
  • In-depth knowledge of regulations and standards that apply to the development of medical devices a plus
  • Experience managing people and acting as a regulatory resource to internal and external clients
  • Effective communication skills both verbal and written, and strong ability to interact with other departments and external organizations
  • Ability to manage multiple projects and complex timelines in a team environment
  • Ability to act as head of Regulatory Affairs department as needed and lead company wide initiatives

Octagon Research Solutions, Inc., is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process. Based in Wayne, PA, Octagon meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution. We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle. Octagon is an Equal Opportunity Employer with an outstanding corporate culture. Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.

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