Senior Associate, Regulatory Affairs
Job Summary - a concise overview of the job
The Senior Associate, Regulatory is responsible for performing all regulatory functions and supporting all efforts pertaining to the submission of ANDAs and subsequent amendments, supplemental ANDA’s, ANDA Annual Reports, Drug Listing and all related regulatory compliance issues to support the company’s internal and external approved product portfolio.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Par Pharmaceutical – Irvine, CA or Chestnut Ridge, NY
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Compile, review and submit assigned ANDAs and subsequent amendments, supplemental applications, Annual Reports, Drug Listing, SPL/PLR (labeling) and all other required regulatory/electronic submissions to FDA.
§ Prepare all submissions in accordance with current FDA requirements.
§ Provide regulatory support for pre- and post-approval submission issues to other internal departments.
§ Act as regulatory liaison with all departments within the Company.
§ Interact/communicate with Project Management on applicable submission and project time lines.
Communication & Collaboration
§ Interact with R&D Formulations, Technical Operations, Analytical R&D, Quality Control, Quality Assurance, Manufacturing and other pertinent functional areas throughout the submission process to ensure all submission related documents are reviewed, all problems identified and addressed concurrently, and assembled in accordance with established time lines.
§ Monitor internal communications (R&D meeting minutes) and department project reports for upcoming changes to approved applications to effectively assist with the coordination of projects.
§ Prioritize work flow to maximize efficiency.
§ Attend various seminars and workshops pertaining to job function.
Regulatory databases and FDA Guidance
§ Monitor FDA CDERNEWS, applicable web sites and other FDA communications concerning required labeling changes for pending and approved/marketed products; disseminate/prepare appropriate documentation to implement changes.
§ Interface with Par contract manufacturers to assess requirements and compile documents for third party submissions.
§ Perform other miscellaneous duties and job responsibilities to support area’s regulatory activities.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Bachelor’s degree in a scientific or other related discipline or an equivalent overall level of knowledge based upon previous work experience.
§ 3 – 5 years’ experience in regulatory affairs plus 2-3 years of other relevant experience.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Knowledge of government regulations, policies and procedures and current Good Manufacturing Practices.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
§ Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
§ 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.
§ Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
§ 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.
§ 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.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Office required due to confidential nature of work.
§ Limited overnight travel may be required
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.