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Regulatory Affairs Associate Manager

Department: Regulatory Affairs
Location: West Columbia, SC

SC REGULATORY AFFAIRS ASSOCIATE MANAGER

Position Summary:

  • Assumes a leadership role in managing the Regulatory Affairs Department ensuring day-to-day regulatory activities are in compliance with government mandated regulations.
  • Works closely under the direction of the Vice President of RA and includes providing leadership, and mentoring other departments on regulatory activities in both domestic and international affairs.
  • Assists with additional work duties or responsibilities as evident or required.
  • Performs other duties as assigned or apparent.

Primary Accountabilities:

  • Maintain current knowledge of relevant U.S. regulations, including proposed and final rules
  • Manage regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Manage the preparation and submission of regulatory agency applications, responses, and any correspondence
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards
  • Provide regulatory guidance to development project teams regarding design, development, evaluation, or marketing of products
  • Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
  • Oversee documentation efforts to ensure compliance with domestic and international regulations and standards
  • Monitor and review adverse event processing systems with Drug Safety Department to ensure effective and timely resolution of all adverse event complaint investigations
  • Maintain electronic publishing tools for regulatory submissions, monitor trends and changes in electronic submission requirements, and evaluate updates and/or new software publishing systems to remain compliant with current regulations and requirements
  • Train staff on regulatory policies or procedures



Knowledge, Skills & Abilities:
NOTE: The primary accountabilities and the knowledge, skills and abilities listed below, are intended to describe the general content of and requirements for this position and are not intended to be an exhaustive statement of duties. Incumbents may perform all or most of the primary accountabilities listed. Specific tasks or responsibilities will be documented in the incumbents’ performance objectives as outlined by the incumbents’ immediate supervisor or manager.

  • Bachelor’s Degree in scientific discipline (advanced degree preferred) with a minimum 3-5 years in the pharmaceutical manufacturing environment with direct regulatory experience, or an equivalent combination of education and experience 
  • Effectively demonstrates current knowledge of FDA, ICH and International regulations
  • Completes all assignments with a high level of attention to details in a fast paced environment
  • Possesses skills in written comprehension through the ability to read and understand complex information and ideas presented in writing
  • Possesses skills in strong oral comprehension through the ability to listen to and understand information and ideas presented through spoken words and sentences
  • Has the ability and willingness to change direction and focus, to meet shifting organizational and business demands which includes the ability to multi task and meet strict deadlines
  • Has the ability to create and contribute environment that values people, encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition
  • Has the ability to effectively manage one’s self, demonstrates integrity, be productive under pressure, and achieve development goals
  • Ability to effectively manage multiple projects and competing priorities
  • Strong interpersonal, communication, and organizational skills
  • Position requires bending (desk to floor), lifting (up to 15 lbs), vision (20/20), standing (5%), sitting (90%), typing and walking (50%)

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