Associate/Sr. Associate, 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 direction of a Manager of Regulatory Affairs or higher, the Associate of Regulatory Affairs is responsible for assigned projects, while supporting Senior Regulatory Affairs staff at the firm on various cross-functional teams and client collaborations.

Essential Functions

  • Expected to develop and maintain his/her knowledge base of laws, regulations and guidelines governing the development, licensure and marketing of drugs and biologics.
  • May assist in facilitating internal staff meetings.
  • May review, provide editing support on regulatory documents, prepare cover letters for routing submissions including investigator packages.
  • Helps ensure that all elements, quality, accuracy and format of regulatory submissions and other documentation comply with applicable laws, regulations and RPI standards.
  • As assigned, performs literature searches, prepares special reports and assembles documentation to support project teams.
  • 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 of the Regulatory Affairs working practices and procedures.
  • Analyzes data, the regulatory environment and business objectives to advise clients on applicability of new or existing regulations and guidelines.
  • Independently prepares routing IND submissions (cover letters, forms, IND annual reports).
  • Supports manager or directors of regulatory affairs in preparing more complex submissions, regulatory intelligence to support regulatory strategies and other regulatory deliverables (global orphan applications, briefing document, HA meeting requests, IB).

Required Qualifications, Skills, and Experience:

  • Bachelors Degree in scientific discipline required; advanced scientific degree (PhD) preferred.
  • Some relevant experience in regulatory affairs or pharmaceutical industry strongly preferred.
  • Knowledge or aptitude to learn international regulatory guidelines as they relate to the overall regulatory strategy.
  • Strong computer skills, attention to detail and ability to multitask.
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously.

Additional Qualification of a Senior Associate include:

  • 3+ years of experience in the pharmaceutical industry, with a minimum of one year in regulatory affairs. International experience desirable.
  • Demonstrated understanding of international regulations, processes and issues in drug/biologics development. Includes sound knowledge of GxP (Good Practices for quality guidelines and practices in the pharmaceutical/biotechnology or related industry), GCP (Good Clinical Practice), ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMA, and other relevant guidelines.
  • Knowledge of the drug development process, with a focus on IND and NDA processes.
  • Results driven and team-orientated, with the ability to influence outcomes as necessary skills in the environment.
  • Must be able to innovate, analyze and solve problems with supervision and exceptionally keen skills for attention to detail.

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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