Manager, Regulatory Affairs

Regulatory Professionals is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world. With a presence in the US, EU, Canada and Japan we are growing and looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.

Under the supervision of a Director/Associate Director, Regulatory Affairs, the Manager of Regulatory Affairs will be responsible for serving as the Regulatory Affairs representative on project teams, providing regulatory support for clinical trial applications and marketing applications, including ongoing trials and post approval activities. In addition, this position will manage the preparation, review and assembly of regulatory submissions to U.S. and international health agencies.

Essential Functions

  • Prepare submissions and oversee the maintenance of regulatory filings to support multinational trials (i.e., INDs, CTAs, amendments, safety updates, and Annual Reports).
  • Review clinical trial documents including clinical protocols/reports, investigator brochures, nonclinical reports, CMC protocols/test methods; review and approve clinical manufacturing plans and labeling, and authorize drug shipment to clinical sites.
  • Assist in the preparation and review of regulatory filings to support U.S. and international marketing applications, applications under review by health agencies, and post-approval products (i.e., NDAs, supplements, MAAs, variations, Annual Reports).
  • Serve as Regulatory representative on project teams, manage regulatory timelines, and provide strategic input as applicable.
  • Liaise with regulatory agency project manager in coordinating meetings, providing responses to agency questions/requests.
  • Assist with the maintenance of ClinTrials.gov. registrations, Orphan Drug applications, CTA applications and Breakthrough designations.
  • Lead the preparation of submissions, which may include INDs, briefing documents, orphan drug applications, and marketing applications.
  • Coordinate with cross-functional teams to define contributions to submissions.
  • Interface with international affiliates on regional regulatory strategy and implementation plans.
  • Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidelines.
  • Contribute to the development and maintenance the Regulatory Affairs working practices and procedures.
  • Conduct business development efforts, if assigned.

Required Qualifications, Skills, and Experience:

  • Bachelors Degree in scientific discipline required; advanced scientific degree (Ph.D.) preferred.
  • 5 years experience in pharmaceutical, biotechnology or device/diagnostics industry; 3+ years of direct Regulatory Affairs experience.
  • Knowledge of international regulatory guidelines as they relate to the overall regulatory strategy.
  • Experience in multiple phases of development in various therapeutic areas.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.
  • Ability to communicate and interact effectively within department, across departments and on project team(s).
  • Thorough knowledge of the drug development process, with a focus on IND and NDA processes.
  • Demonstrated experience in preparing new IND.
  • Results driven and team-orientated, with the ability to influence outcomes as necessary skills in the environment.
  • Maintain an understanding of the relevant regulations and guidelines governing drug development, approval and marketed products.
  • Demonstrated ability to manage a staff of up to 1-2 associates to achieve company and client goals.

RPI is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

RPI complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for RPI in the U.S.

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