Job: Manager/Senior Manager, Regulatory Affairs – Submissions

Title Manager/Senior Manager, Regulatory Affairs – Submissions
Categories Regulatory Affairs
Reporting To Vice President

The Manager/Senior Manager, Regulatory Affairs-Submissions is responsible for the coordination of regulatory efforts relating to the compilation, review and submission of ANDAs, amendments, and post approval submissions to support the company’s internal and external R&D pipeline. Additionally, the Manager/Senior Manager will be responsible for assisting with the review of department submissions, as well as assisting with complex CMC issues.

Specific Responsibilities
  • Coordinate the compilation, review and submission process for ANDA’s, subsequent amendments, including SPL/PLR (labeling), all interactions and communications with the FDA from product inception to approval, including regulatory support during Pre-Approval Inspections for assigned projects.
  • Assist with the final review of department submissions, as well as with complex CMC issues.
  • Review technical documents from support groups for acceptability from a regulatory filing perspective.
  • Coordinate the compilation, review and submission process for Post Approval submissions, including SPL/PLR (labeling), including all interactions and communications with the FDA. 
  • Communicate with R&D Formulations, Technical Operations, Analytical R&D, Manufacturing, Quality Control, Quality Assurance and Amerigens’s internal audit group throughout the development and submission process to ensure all submission related documents (batch manufacturing and control records, packaging records and analytical reports) are assembled and reviewed on an ongoing basis, with problems identified and addressed concurrently.
  • Communicate and effectively follow-up with the FDA on various regulatory issues.
  • Interact and communicate with Project Management on submission and project time lines.
  • Utilize and remain current with internal/external electronic submission initiatives.
  • Prioritize work flow to maximize efficiency. 
  • Interface with internal/external legal counsel and Business Development on patent infringement issues, paragraph IV certifications and notices to patent holders.
  • Insure that the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and USPTO databases are monitored on a regular basis for updated patent and exclusivity information that may affect potential or pending ANDA products.
  • Monitor FDA CDERNEWS and applicable web sites for new Orange Book listings, competitor Paragraph IV Certifications/Approvals and New Guidances, labeling updates that may impact pending/future ANDAs and provide impact on project/company.
  • Conduct regulatory review of innovator products, associated patent and exclusivity status, including pediatric extensions for new product submissions.
  • Conduct regulatory due diligence for internal and/or external R&D projects.
  • Review of company change requests and associated documentation to support change, as assigned.
  • Prepare and/or review of new and revised departmental Standard Operating Procedures.
  • Participate and represent department at project meetings.
Desired Skills & Experience

Supervisory Responsibilities:

  • Number of exempt employees supervised: 0 – 1
  • Number of non- exempt employees supervised: 0

Education and or Experience:

  • Bachelor’s degree in a scientific or other related discipline or an equivalent overall level of knowledge based upon previous work experience.
  • 5 – 8 years experience in regulatory affairs
  • Knowledge of government regulations, policies and procedures and current Good Manufacturing Practices

Competencies: To perform this job successfully, an individual should have

  • Quality – Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
  • Planning/Organizing – Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
  • Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
  • Quantity – Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
  • Written Communication – Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
  • Oral Communication – Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.
  • Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
  • Adaptability – Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.
  • Innovation – Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.
  • Judgment – Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
  • Motivation – Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.

Physical Demands / Work Environment:

  • The physical demands/work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Office required due to confidential nature of work.
  • Limited overnight travel may be required.
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