Regulatory Affairs Consultant

Our client is dedicated to preventing blindness and they are developing and commercializing innovative ophthalmic products for the treatment of serious eye disorders.  They are seeking a Regulatory Affairs Consultant who can provide strategic regulatory direction for the company’s clinical-stage programs. Reporting into the SVP/Head of Regulatory, you will be responsible for developing Clinical Regulatory strategies and prioritizing the pipeline of development programs. You will help to facilitate the earliest possible approvals of the company’s regulatory applications for new products and line extensions.   This engagement will be approximately 3-6 months.

Responsibilities:

  • Develop and execute on clinical regulatory activities to secure approval of new ophthalmic drugs.
  • Provide regulatory risk assessment for projects based on regulatory precedence and product characteristics.
  • Prepare and review regulatory filings (IND, NDA, ANDA, etc.) including authorship of critical documents as needed.
  • Provide regulatory guidance to product development teams for programs in development.
  • Preparation of FDA meeting documents, meeting requests, meeting packages, etc.
  • Support interactions with FDA, EMA and other regulatory authorities.
  • Manage regulatory submission timelines in accordance with project plans.
  • Support transparent and proactive interactions with regulatory agencies globally.
  • Collaborate with cross-functional teams to ensure seamless integration of various components into submissions as well as high quality submissions per agreed to timelines.
  • Provide regulatory expertise and policy support for good pharmaceutical development practices (GCPs, GMPs and GLPs)
  • Conduct regulatory intelligence and monitor the impact of new government regulatory activities.
  • Serve as subject matter expert in global regulatory processes, laws, and regulations, particularly within the U.S. with FDA.

Qualifications:

  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
  • 10+ years of Drug Development and Regulatory Affairs experience. Background in Ophthalmology and Retinal disease experience highly desired.
  • Strong experience with clinical regulatory strategy for programs in development.
  • Successful track record of filing of INDs, NDAs, sNDAs, briefing packages, and various other important regulatory documents.
  • Direct experience interacting with FDA and/or other health authorities.
  • Strong working knowledge of electronic document and submission standards and requirements applicable to the US regulatory environment.
  • Experienced in eCTD publishing.
  • Detail oriented with excellent oral and written communication skills, including proficiency in scientific writing, and experience interfacing with management.
  • Strong organizational skills and ability to maintain a high level of communication, productivity, innovation, and priority‐setting to meet aggressive timelines.

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