Senior Regulatory Affairs Associate – Langhorne, PA
To offer regulatory guidance and advise to project teams and preparation and review of content for regulatory submissions.
- Prepare and submit eCTD submissions for generic and new drug development projects and marketed products to ensure timely submissions to the FDA (Original Applications, Amendments, Supplements, and Annual Reports).
- Interpret FDA Guidances and advise stakeholders such as R&D, Operations, and Business Development.
- Prepare and assist submitting Drug Listing and SPL/PLR submissions
- Manage electronic submissions to FDA in eCTD format.
- Review change control documents, batch records, and other technical documents
- Coordinate and work with Regulatory/R&D colleagues for the preparation of regulatory submissions
- Keep current with existing/pending regulations and FDA Guidances for generic drugs and new drugs to ensure compliance with Regulatory Agency requirements.
- Participate in the development and maintenance of Regulatory Operations systems, processes, checklists and procedures to facilitate consistency.
- Organize and maintain Regulatory application records and indices in the Regulatory Operation Center
- Prepare and review labeling and promotional materials for submission to the Regulatory Agency
- Maintain GDUFA Self-Identification status and update annually
- Assist in annual GDUFA User Fee payments
- Maintain/update Facility Establishment Registration status
- Maintain and renew other permits and licenses
- Assist in authoring and finalizing departmental SOPs
ESSENTIAL JOB REQUIREMENTS AND QUALIFICATIONS:
- Must have experience with the ANDA submission process from start to completion
- SPL labeling experience is a plus
- Proficiency in eCTD publishing software is a must
- Excellent attention to details
- Excellent verbal and written communication skill
- Good understanding of regulatory requirements for ANDAs and 505b(2) applications
- Good knowledge of FDA guidelines, ICH and related guidelines
- Demonstrates a basic understanding of pharmaceutical drug development.
- Proficiency in Microsoft office and XML programs
- Ability to manage timelines and priorities
- Ability to work independently with some guidance
- Ability to multi-task
- Ability to establish and maintain good working relationship
- Pre- and post-approval experience is highly desired
- Knowledge in Pharmacovigilance
EDUCATION AND EXPERIENCE:
- Bachelor's Degree in Scientific discipline
- Minimum 5 years' experience in the Generic Pharma industry
- Previous R&D (analytical or formulation) experience is a plus
- 505b(2) experience is a plus
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