PHARMACEUTICAL REGULATORY AFFAIRS MANAGER

THIS OPPORTUNITY IS IN ST. LOUIS, MO. RELOCATION IS PAID. WE ARE SEARCHING NATIONWIDE FOR THE CANDIDATE WHO HAS THE EXACT EXPERIENCE AND IS OPEN TO ST. LOUIS.

PURPOSE OF THIS JOB POSTING: I am a third party recruiter working with my client pharmaceutical company to find candidates for this excellent Regulatory Affairs opportunity. This job is based in St. Louis. The candidate we seek has the required experience as outlined below AND is open to relocating to St. Louis at company expense. This is a detailed job description so that you can make a better decision as to whether this opportunity matches you and your families’ goals.

THE CANDIDATE WE SEEK COULD BE ANYWHERE IN THE USA: They are now with another pharma company in RA but would be open to move for a number of reasons such as a return home, or perhaps a wish to get away from the heavy congestion, traffic, or high cost of living where they are now, or are seeking a better opportunity and quality of life.

WHAT DOES THIS COMPANY HAVE TO OFFER YOU? This is a fast paced, fast growing pharmaceutical company with many new products in the development pipeline. This division is involved in new product development. Your job will be heavily writing new programs and in new product submission rather than just maintenance, compliance and fixing old problems. You will be involved with branded and generic submissions with the mix shifting to heavy branded as new products become available.

BASE SALARY RANGE: This company offers a range up to $86,300 plus bonus opportunity. They will cover relocation. St. Louis is a beautiful, growing city with a very favorable cost of living comparison.

BRIEF OF REQUIRED EXPERIENCE: The person we seek has experience with another Pharmaceutical Company and understands the strategy and process of submitting new drugs to the FDA for the approval process. This person has already been involved in running a new product project from beginning to application. They know how to develop a Regulatory strategy and put together a good application for both branded and generic pharmaceutical products.

EXPERIENCE DETAILS: BS or BA in Chemistry, Pharmacy, or other Life Science, or equivalent experience. Should have at least 6 years experience in a Pharmaceutical Regulatory Affairs environment, with at least the last 4 in regulatory affairs in new drug submissions with FDA experience. Experience with pharmaceutical manufacturing and equipment, marketing, and quality assurance is desired to understand how pharmaceutical products are produced and marketed. Ability to interpret data and information, review the work of others for technical adequacy, drafting an application, and interacting with the reviewers at the FDA is important.

JOB DESCRIPTION DETAIL: Provide administrative and technical support to Regulatory Affairs management in order to remain in compliance with all FDA and other U.S. and international regulatory requirements. Prepare portions of 510(k), IDE, PMA original submissions and subsequent revisions/supplements. Conduct presentations to FDA reviewers and/or inspectors as needed. Interpret existing or new regulatory requirements as they relate to company products and procedures, clinical studies, testing, or records keeping. Provide input to development teams to assure that FDA requirements are incorporated as part of development process. Review and advise on labeling, product claims, or marketing programs to ensure compliance with regulations. Review and advise on international product registration and licensing requirements. Maintain information in various compliance databases and produce reports as needed.