Director, Regulatory Affairs in Parsippany, NJ

$200K - $250K(Ladders Estimates)

Ferring Pharmaceuticals, Inc.   •  

Parsippany, NJ 07054

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 56 days ago

Job Description:

Ferring Pharmaceuticals is a globally recognized, research-driven, biopharmaceutical company with more than 65 years of history. Headquartered in Switzerland, Ferring is privately owned with over 5,700 employees in nearly 60 countries. In the United States, Ferring identifies, develops and markets innovative products in the fields of reproductive health (infertility), urology, gastroenterology, endocrinology, women's health (obstetrics/gynecology) and orthopaedics. Ferring's US operations employ approximately 800 people.

People Come First At Ferring. The Ferring Philosophy places people at the heart of what we do. This guides our relations with patients, physicians, employees, and other stakeholders. We invite you to share our passion for people and the power of science.

Summary:

Purpose of role is to optimize US Regulatory strategies for therapeutic areas, supervise the execution of those strategies, and build/maintain good relationships with FDA to achieve optimal outcomes for approval of new products and maintenance of existing products.

Responsibilities:


  • Therapeutic Area lead for assigned products and projects
  • Responsible for preparing the US Regulatory Strategy, input into the Global Strategy and collaborating with local or global teams, as assigned; also accountable for implementation of the strategies
  • Serve as the regulatory liaison with the FDA, including meetings and phone calls and associated documentation of same.
  • Serve as liaison for outside contractor and partners associated with assigned projects or products
  • Serve as Regulatory Subject matter Expert for Ferring, including FDA regulations and Guidance interpretations
  • Develop and implement regulatory timelines for both pre and post approval submissions that align with company goals and adhere to those agreed timelines by effectively managing departmental and external resources
  • Responsible for adherence of technical content to regulations and Guidances or deviations agreed with FDA, as well as overall fileability of new submissions and compliance for approved products
  • Responsible for processes related to INDs, NDAs and BLAs as well as associated linking and quality check of the electronic versions
  • Problem-solve issues that may happen on projects, to preserve original timelines; track progress while being accountable for regulatory deliverables
  • Maintaining good regulatory archives as well as good communications with the project teams
  • Select, contract, and oversee consultants for scientific and/or policy areas of development
  • Anticipate need for resources and budget those needs in advance.

Requirements:


  • Bachelor's degree in biochemistry, chemistry, biology or related pharmaceutical field
  • 10 plus years experience in drug development and regulatory strategy experience
  • Must have strong content knowledge of US and global submissions
  • Experience influencing without authority and acting as a regulatory resource to internal and external clients
  • Effective communication skills both verbal and written, and strong ability to interact with other departments and external organizations
  • Ability to manage multiple projects and complex timelines in a team environment


Valid Through: 2019-10-17