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Manager of Regulatory Affairs

Mason, Ohio
General Purpose of Position:
Responsible for the preparation, review, and submission of regulatory filings (e.g. original NDAs/ANDAs, annual reports, supplements, CBEs (Changes Being Effected), protocols, etc.), tracking and updating status reports for drug product registrations.  Regulatory responsibilities also include post-approval drug product reporting activities such as completing regulatory impact assessments for commercial drug product changes, filing labeling and promotional material submissions, supporting adverse event reporting activities and developing appropriate regulatory strategies to support business objectives. 

Primary Duties and Responsibilities (Essential Functions):
 
  Duties/Responsibilities
1 Work with Product Development, Technical Services, Analytical, Project Management, Quality Assurance and other staff contributing to the preparation of CMC (Chemistry, Manufacturing, and Controls) and/or clinical, and regulatory submissions.
2 Develop regulatory submission timelines, eCTD (electronic Common Technical Dossier) submission content plans and table of contents, as necessary.
3 Ensure that all eCTD submissions and sections are consistent with regulatory requirements, internal submission criteria, and format standards as necessary for US and international drug product registration applications.
4 Prepare, author, and review regulatory submissions for regulatory compliance, accuracy, and quality.  Examples include IND (Investigational New Drug Application), NDA (New Drug Application), PAS (Prior Approval Supplement), AR (Annual Report), and regulatory meeting briefing packages.
5 Remain current with existing and developing FDA regulations, review new regulatory guidance documents and associated regulatory information, and inform RA and other staff regarding applicability and impact of emerging regulations.
6 Review and approve technical and scientific protocols, reports, change controls, and other GMP documents for the RA department. 
7 Complete regulatory impact assessments for commercial drug product changes and develop regulatory strategies to support business objectives.
8 Manage development and revisions to Aprecia product labeling. Ensure labeling is kept current with 505(b)(2) Listed Drugs as necessary.
9 Participate in Medical, Legal and Regulatory (MLR) team reviews for Aprecia drug product advertising and promotional materials.  Provide regulatory approval of labeling and promotional materials in the MLR process.  Prepare and file FDA labeling and promotional material submissions and communicate dissemination dates to appropriate personnel.
10 Provide support and/or oversight for outsourced pharmacovigilance activities and file safety report submissions with the FDA or other authorities as necessary. 
11 Collaborate with Scientific Affairs leadership and other team members regarding projects and perform other duties as assigned.
12 Complete and/or manage all responsibilities expected of a Regulatory Affairs Manager.

Reporting to this Position:
No direct reports

Travel:
Position may require up to 10% travel

Work Shift:
This position works days, but may include extended hours and weekend work when required

Knowledge, Skills and Abilities:
  • Excellent oral and written communication skills
  • Strong problem solving and critical thinking skills
  • Strong organizational skills and attention to detail
  • Strong familiarity with MSOffice
  • Working knowledge of cGMPs (current Good Manufacturing Practices) and FDA (Food & Drug Administration) pharmaceutical regulations
  • Strong command of internet search tools and techniques for research-related responsibilities
  • Good time management with demonstrated ability to manage multiple priorities simultaneously
  • Able to operate successfully in a team environment
  • Strong interpersonal and influencing skills to participate and/or lead (as needed) cross-functional teams, successfully challenging them to work collaboratively on solutions and meet project deadlines
Education and Experience:
  • B.S. degree in Biology, Chemistry, or Allied Health Sciences desired
  • M.S. degree in Pharmacy (or a related scientific field) or M.P.H. preferred
  • Minimum 6 years of prior experience working in the pharmaceutical industry or equivalent process-related industry.  Less experience may be acceptable with a graduate degree
Physical Demands and Work Environment:    
  • Ability to sit for extended periods at a desk
  • Occasional awkward positions (bending, kneeling, reaching, etc.) in the performance of the job
  • Ability to wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (e.g. respirators, over-gowning, gloves, steel toe shoes)
  • Good eyesight to tolerate extended viewing of computer screen.  Able to read, interpret, and create business documents and communications
  • Good manual dexterity to operate computer, keyboards, and general office equipment
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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