Regulatory Affairs Associate
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Regulatory Affairs Associate
Ref No.: 14-09921
Location: Horsham, Pennsylvania
Position Title:Senior Regulatory Associate
Supervisor's Title Sr. Manager and/or Associate Director, Regulatory Affairs (Sterile group)
Location:Horsham, PA
Position Summary

With minimal guidance, prepares, reviews and submits high quality, regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. Submissions include supplements to ANDAs, Annual Reports and additional documents as needed. This senior level position evaluates regulatory issues and provides accurate and timely recommendations and alternatives, as needed, with the guidance of the Sr. Manager/ Associate Director. With minimal guidance this senior level associate attends and represents Regulatory Affairs at meetings and serves as a team leader on projects. This position provides guidance to more junior associates and other business units and therefore, must have a firm command of regulations, and guidelines.

Travel Requirements:


Essential Duties & Responsibilities
Coordinates, prepares, and reviews all appropriate regulatory submissions (ANDA supplements, deficiency responses, and Annual Reports) for FDA submissions within a specified time frame in conjunction with the organization
Evaluates changes to regulatory documents and formulates strategies for correct filing categories, with guidance from supervisor.
Interacts effectively with functional business units in order to coordinate and facilitate documentation required for submissions, ensuring that departmental timelines are met.
Coaches and mentors other associates. Reviews change controls and submissions prepared by more junior associates and provides guidance and feedback.
Other duties, as assigned, or as business needs require5%
Follows Client's Safety, Health, and Environmental policies and procedures5%

Primary Outcomes:
On time submission and approval of supplements and Annual Reports
Accurate and timely assessment of change control documents for determination of reporting category.
Maintain approved applications in compliance with FDA regulations.
Provide appropriate regulatory guidance to quality and manufacturing/operations departments.

Position RequirementsEducation Required:Minimum Bachelor's degree in scientific or healthcare discipline or equivalent combination of education and related experience. Education Preferred:RAPS RAC (U.S. or EU) Experience Required:Minimum of 4 years pharmaceutical industry experience with at least 3 years in regulatory affairs.
Experience with eCTD. Experience Preferred: Experience working within Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical industry, working with parenteral drug application. Specialized or Technical Knowledge Licenses, Certifications needed:RAC certification beneficial, but not required; working knowledge of CMC as needed for ANDA submissions. Prior pharmaceutical experience involving chemistry or manufacturing.

Performance CompetenciesTechnical
  • Demonstrates an understanding of ICH and FDA guidelines
  • Demonstrates proficiency with computer and familiarity with electronic document management.
Planning and Organization
  • Demonstrates ability to negotiate response to FDA deficiencies in a manner acceptable to both FDA and affected Client departments.
  • Demonstrates judgment in determining appropriate filing categories of post-approval changes.
  • Demonstrates ability to establish sound professional relationships with other Client departments and Government employees.
  • Demonstrates excellent oral and written communication skills, including editing of documents by others.
Autonomy and Independence
  • Ability to manage multiple priorities effectively and work independently with minimal supervision.

Additional information:
  • Hours will be betweeen 8:00am - 5:00pm. Hours are not negotiable.
  • CMC Experience is required, as well as strong experience authoring and reviewing regulatory documentation.
  • Prefer candidates with a BS in a Scientific field.