Regulatory Affairs Director

Miami, FL

Posted: 04/17/2019 Job Number: JN -042019-10635
Regulatory Affairs Director

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to rapidly and precisely match professionals to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.

Title: Regulatory Affairs Director
Location: Miami, FL
Industry: Pharmaceutical
Hours: 1st Shift Monday-Friday, 8am-5pm
Salary: Competitive salary and compensation package. Relocation assistance offered for the right individual
Employment Type: Direct hire

Environment: This client
is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.

Overview:
One will direct the regulatory process for products requiring governmental approval by ensuring that all necessary information is included in the submission to be accepted for review in a single review cycle. The Director of Regulatory Affairs coordinates all government interactions during the review cycle and assures all government requests are addressed within the given timeframes. Assists in developing procedures to ensure regulatory compliance. This position is also responsible for the successful lifecycle management of the ANDA/NDA portfolio. This position will expand the regulatory capability by developing a team capable to prepare, review and submit eCTD ANDAs, NDA Rx-to-OTC switch submissions and 505b2 NDA submissions. This position will also work with the labeling and pharmacovigilance departments.

Responsibilities:
  • Individual will participate on Continuous Quality Improvement Teams (CQIT s), actively participate in Customer Project Teams (CPT s) and New Product Introduction (NPI) teams. Also provides regulatory strategic input to the project team on assigned project(s).
  • Designs and implements regulatory strategies to grant a speedy and optimal access of new products (Medical Foods, Medical Devices and Prescription drugs) to the market.
  • Ensures full compliance with Regulatory and Pharmacovigilance legislation and guidelines.
  • Engages with government bodies, external consultants, and functional industry associations.
  • Supports the Manufacturing Quality and Technical Groups.
  • High exposure to and involvement with industry groups, government authorities (FDA), and scientific societies such as RAPS, DIA, AAM, etc.
Qualifications:
  • Minimum Bachelors Degree (B.S.) in a Physical Science, preferable Industrial Pharmacy, Chemistry, Biochemistry, Pharmacology etc. with 10+ years of industry experience and a minimum of 5 years of management and leadership experience in Regulatory Affairs in the pharmaceutical industry
  • One must have ANDA experience
  • Strong Knowlegde of 21 CFR Part 201 Subpart C (Labeling Requirements for Over-the-Counter Drugs)
  • Adverse Drug Experience Reporting Experience
  • Working Knowledge of FDA cGMP including Stability to Support repackaging of Bulk OTC Products
  • Experience with FDA Field Alerts and other CFR requirements for NDAs/ANDAs (21 CFR 314)
  • Excellent verbal and written communication skills is required
  • Prior experience communicating and negotiating with FDA related to sponsor Information Requests, Complete Response Letter and FDA investigators.
  • Experience with OTC drug packaging and labeling (manufacturing experience a plus)
  • Work in teams to achieve results, make recommendations and improvements
  • Prepare presentations to senior management
  • Demonstrated experience with CMC regulatory review and submissions and an understanding of SPL Labeling and NDC Listing.
ADA/EOE
Search words: Regulatory Affairs, RA, ANDA, OTC, over-the-counter, labeling, 21 CFR, generics, manufacturing, RAPS, eCTD, submissions

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