Regulatory Affairs Specialist - PVG
Inspiration, imagination, and innovation. Here at Aerie Pharmaceuticals, we share this passion for finding new approaches to protecting vision. United by great science, deep clinical insight, and a singular focus on your ophthalmic needs, we see the possibilities ahead and invite you to join us in creating the future of eye care.
Aerie Pharmaceuticals seeks qualified candidates for a full-time position in our Regulatory Affairs department located in Irvine, CA
The Regulatory Affairs Specialist is supporting the creation, revision and review of various documents with emphasis in clinical research and meeting the regulatory requirements of US Food and Drug Administration (FDA) and other international and regional governing bodies and Health Agencies (HAs). The documents may be submitted to support clinical development, registration, and regulatory compliance of Aerie’s drug products, worldwide. This position supports also Aerie’s postmarketing pharmacovigilance (PVG) and promotional activities, as needed.
Essential Duties and Responsibilities:
- Utilizing a high level of independent professional judgement and discretion, assists in writing, editing and reviewing of diverse regulatory and clinical documents including study protocols, clinical data summaries, cover letters, forms, and other medical/regulatory documents in support of regulatory investigational and marketing applications (IND, CTN, NDAs, NDS, MA) and associated periodic reports, amendments, supplements and briefing documents.
- Assists in preparing HA required annual updates by scheduling and coordinating receipt of documentation/information, preparing cover pages describing changes made to the application, and tracking progress of their preparation. This duty includes the review of documents, setting up meetings and interacting across functional groups (QA, Clinical R&D, Clinical Ops, Medical Affairs, etc.).
- Support postmarketing PVG, by triaging, reviewing and archiving safety information reports obtained from Aerie’s vendors, participating in PVG-related meetings and teleconferences and preparing/reviewing periodic safety reports prior to submission to HA’s i.e., US FDA.
- Review promotional and medical/clinical information material to ensure compliance with US regulations and PhRMA Code.
- Regulatory representative on product development teams and sub-teams as needed.
- Maintain current knowledge of regulations and guidance’s by utilizing respective websites e.g., ICH, FDA, EMA and attendance of conferences and/or webinars.
- Author, review, and update standard operating procedures (SOPs), as needed and ensure SOPs are compliant with current regulatory requirements.
- Complete projects in a timely manner consistent with corporate objectives. Proactively communicate project status, regulatory issues and opportunities to Director.
- Research projects, background and competitive literature as required.
- Work in accordance with Federal Regulations, Good Clinical Practices, ICH guidelines, Aerie’s Standard Operating Procedures and departmental processes and procedures.
Education & Experience
Specialist II - B.A. or B.S. degree in a scientific field, e.g., chemistry, biology or pharmacology and 3-5 years related work experience in the pharmaceutical industry.
Specialist III - B.A. or B.S. degree in a scientific field, e.g., chemistry, biology or pharmacology and 5-8 years related work experience in the pharmaceutical industry.
Knowledge & Abilities
- Working knowledge of clinical research and related regulations and requirements to support the development, approval and postapproval life-cycle of pharmaceutical products.
- Proactive, problem solving and attention to detail.
- Ability to search, find and interpret relevant regulations, guidance documents and forms issued by health agencies (FDA, EMA, PMDA, Health Canada).
- Working knowledge of regulatory submission content in eCTD format.
- Proven ability to prepare and compile standard regulatory submissions (e.g., periodic reports, IND amendments).
- Proficient in Microsoft Office Suite and accustomed to work with templates.
- Excellent written and oral communication skills.
- Must be able to plan and meet timelines.
- Ability to understand and interpret scientific data and clinical information as it applies to the regulation of pharmaceutical products.
- Experience in review of promotional materials and/or in post-marketing Pharmacovigilance is a must
Physical Demands and Work Environment
The physical demand described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Standard office environment multiple floors with stairs and elevator.
- Standard physical demands, sitting at desk, working at computer.
Aerie Pharmaceuticals is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status, or any other protected category.