Regulatory Manager (US)

SCOPE OF POSITION

We are looking for a regulatory professional with experience in the pharma industry ready to make that next step in their career as a Regulatory Manager.
As the Regulatory Manager, you will be responsible for the oversight of all regulatory matters ensuring the company is compliant with all governing, regulatory and agency requirements, including FDA and nuclear. You will combine your knowledge of regulatory, scientific, nuclear and business issues to enable products that are developed, manufactured and/or distributed to meet required legislation and regulations.
The position will be responsible for:
  • Writing, preparing, compiling, reviewing and managing all regulatory submissions and filings required for the FDA and all other governing authorities.
  • Evaluating changes to existing products for impact on regulatory affairs submissions.
  • Monitoring the impact of changing regulations on submission strategies and update internal stakeholders.
  • Monitoring applications under regulatory review.
  • Preparing and submitting applicable reports ensuring appropriate responses are submitted to regulatory authorities in a timely manner.
  • Developing and executing strategic initiatives relating to Regulatory.
  • Providing input on technical guidance and regulatory requirements to communicate with internal teams and personnel.
  • Supporting product development teams regarding implementation of regulatory requirements.
  • Overseeing processes involved in maintaining annual licenses, registrations and listings.
  • Ensuring compliance with product post marketing approval requirements.
  • Overseeing system(s) to ensure that product safety issues and product associated events are reported to regulatory agencies.
  • Reporting adverse events to regulatory agencies and internal stakeholders.
  • Developing, maintaining and updating regulatory affairs procedures and changes.
  • Providing validation services and activities including gap analysis and remediation, and execution for all compliance programs and processes.
  • Reviewing and assisting with continuous improvement of the submission process.
  • Performing clinical and vendor audits and investigations.
  • Maintaining site monitoring along with administering vendor qualification programs.
  • Serving as the primary contact for all regulatory and governing agencies.
The successful candidate will have:
  • A Degree in Pharma, Chemistry, Microbiology or other related field. A related advanced degree is preferred.
  • Regulatory Affairs Certificate (RAC) preferred.
  • A minimum of 10 years of relevant, solid and progressive experience in the pharmaceutical field with an emphasis on radio/nuclear pharma and/or product development.
  • Prior experience working with the FDA, nuclear, regulatory and other governing agencies.
  • Understanding of regulatory processes in both pre- and post- marketing, preferred.
  • Prior experience with Part II, 211 submissions and filings.
  • Thorough understanding of government and regulatory agencies and in-depth knowledge of the laws, regulations and guidelines that govern.
  • Excellent communication, organization, analytical, presentation, negotiation and compute/pc skills (including proficiency with Microsoft Office 365 and other related software) are required.
  • Requires knowledge of software development and software quality relating to regulatory submissions.
  • Strong attention to detail.
  • The ability to travel on a domestic and international basis, up to 50%.
  • Project management experience in R&D drug development.
  • The ability to work in a team environment as well as independently as an individual contributor.
Who are we? We are newly created international company developing and commercializing molecular imaging companion diagnostics (CDx) for targeted therapies in Oncology that will help clinicians find the right treatment for the right patient at the right time. We are ZIONEXA.
Come be a part of this exciting journey. For immediate consideration, please submit your resume/cv to: hr@zionexa.com.