Regulatory Affairs Associate II

Regulatory Affairs Philadelphia, Pennsylvania


Description

The candidate will be expected to prepare and review many types of documents for submission to the FDA, including the following (not an all-inclusive list), in a format compliant with FDA standards. In addition, the candidate will be expected to communicate with FDA and represent the Regulatory Affairs department in cross functional team meetings and must possess a strong understanding of regulations and guidances. The applicant will assist in determining regulatory strategy for new submissions and post-approval changes. The applicant will also be required to review controlled documents for conformance to regulatory requirements. Additional types of assignments may be given, as needed.

 

  • Abbreviated New Drug Applications
  • Supplemental Applications
  • Amendments
  • Annual Reports
  • Adverse Experience Reports

 

The ideal candidate must have experience with thoroughly reviewing documentation for accuracy and completeness, and successfully communicating with FDA and other stakeholders (internal and external). The candidate must have the ability to work independently and manage/prioritize projects to ensure targeted timelines are met. Background requirements:

  • A minimum of 2 years’ experience in Regulatory Affairs with a generics company is preferred
  • A minimum of a Bachelor’s degree, preferably in Chemistry or a related, scientific discipline
  • Experience with Adobe Acrobat and Windows-based programs such as Microsoft Word, Excel, and SharePoint is required

 

 

Scope of Job – size of organization, P&L responsibility, budget responsibility

N/A

 

 

 

 

 

Key Accountabilities – essential duties/responsibilities

Accountability

Responsibilities

% of Time

 

 

 

 

FDA Submissions

Independently prepare:

·        Original ANDAs

·        Amendments

·        Supplements

·        Annual Reports

·        PADER Reports

 

 

 

60%

 

 

Documentation

·        Determine Filing Strategy

·        Assess Change Controls

·        Author and Review of Submission Ready Documentation

 

 

20%

 

Departmental Procedures

 

 

 

·        Train on SOPs

·        Author and Train on Best Practices/Work Instructions

 

 

 

10%

 

 

Regulatory Guidance

 

 

·        Represent Regulatory Affairs in Meetings

·        Act as an informal resource for Associate I employees

 

 

 

10%

Total Accountabilities

 

 

100%

 

 

Qualifications

Education and Experience:

 

Required

Preferred

¨   High School Diploma / GED

¨    High School Diploma / GED

¨    Associate’s Degree

¨   Associate’s Degree

X    Bachelor’s Degree (Chemistry, Biology, Pharmacy, or related science)

¨    Bachelor’s Degree

¨    Master’s Degree or      ¨ Ph.D.

X    Master’s Degree or      ¨ Ph.D.

¨    Other

¨    Other

 

 

 

Experience

(Industry and Years)

Work experience (type of industry and years of experience) and certifications required for the job.

Minimum 2 years regulatory experience or relevant knowledge base in the pharmaceutical industry

 

 

Specific Skills

List any additional specific skills and knowledge necessary to meet the objectives of the position; including any specialized software or equipment regularly utilized in the performance of the job, analytical skills, management or leadership skills, etc.

·        Strong communications/negotiation skills

·        Strong Analytical skills, problem solving

·        A high level of integrity

·        Ability to work independently and in a team environment

 

 

 

 

 

Physical Requirements

List the details of the environment within/under which work is performed and physical requirements for this position, e.g., lift 50 pounds, and walk across plant/warehouse, business travel (% of time).

·        Business travel may be required (25% of time)