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Jobs at Aprecia Pharmaceuticals, LLC

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Regulatory Affairs Intern

Mason, Ohio
Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Support ongoing Regulatory Affairs projects by engaging in departmental discussions and preparing regulatory documentation in accordance with applicable FDA/regulatory guidance documents.
2 Participate in cross-functional Aprecia team meetings as a Regulatory Affairs representative.
3 Perform regulatory impact assessments for chemistry, manufacturing and controls (CMC) and labeling documentation changes.
4 Prepare and review Abbreviated New Drug Applications (ANDA) Common Technical Document (CTD) sections in accordance with regulatory department guidance and FDA requirements.
5 Independently complete a review of FDA regulatory requirements for the use of artificial intelligence in GMP environments and report results to cross-functional Aprecia teams.
6 Track and update status reports for drug product registrations under preparation.
7 Support pharmacovigilance and adverse event reporting activities as assigned.
8 Collaborate with team members regarding projects and perform other duties as assigned.

Reporting to this Position:
No direct reports

Travel:
Position may require 0-5% travel

Work Shift:
This position works days

Knowledge, Skills and Abilities:
  • Good organizational skills with a collaborative approach to problem solving
  • Excellent written and verbal communication skills
  • Self-directed and motivated for completion of projects
  • Strong project management skillset preferred
  • Familiarity with manufacturing processes, automation, and/or 3D printing preferred
Education and Experience:
  • Working towards a B.S. degree in Life Sciences, Engineering, Advanced Manufacturing or a related discipline required
  • Possess previous research, co-op, internship, or work experience in a related field
  • Ability to work in a regulated environment
  • Demonstrated leadership/participation in campus programs and/or community service activities.
  • GPA of 3.0 or above
Physical Demands and Work Environment:    
  • Ability to sit at desk for extended periods of time
  • Extended viewing of computer screens and manual dexterity to operate office equipment
  • Ability to perform minimal lifting (typically less than 25 pounds), walking, and physical exertion (bending, kneeling, twisting, climbing) specific to physical inventories and related work
  • Good eyesight and critical thinking to read, create and interpret business documents and spreadsheets
GENERAL INFORMATION:
The expectation for all employees is to support the company’s mission, vision, culture and core values while adhering to all company policies.  The above information is intended to describe the general nature and level of work being performed by individuals assigned to this position.  It is not intended to be an exhaustive list of all duties, responsibilities, and skills required.  The position may require other duties as assigned and can be changed at any time by the company.

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, genetic information, sexual orientation, gender identity, national origin, disability or veteran status.

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