Director, Regulatory Affairs - Parsippany, NJ | Biospace
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Director, Regulatory Affairs

Ferring Pharmaceuticals, Inc.

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Location:
Parsippany, NJ
Posted Date:
7/26/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Director, Regulatory Affairs,

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:

•   Navigate and supervise regulatory representatives (Regulatory liaison roles) on project teams, assuring that regulatory strategies are written, understood, and implemented.
•   Problem-solve issues that may happen on projects, to preserve original timelines; track progress while being accountable for regulatory deliverables
•   Liaise with FDA before and during FDA reviews, maintaining good regulatory archives as well as good communications with the team
•   Primary US Regulatory team member on project teams, responsible for overall product/project strategy, tracking, advise, execution and approval.
•   Select, contract, and oversee consultants for scientific and/or policy areas of development
•   Anticipate need for resources and budget those needs in advance.

Requirements


Requirements:

•   Scientific degree.  Pharmacy or Clinical Science preferred; advanced degree preferred
•   10+ years’ experience with FDA or US Regulatory Affairs
•   Ex-FDA or demonstrated years of success in approval of drugs, biologics, devices and/or combination products
•   Fewer review cycles (right first time) before approvals
•   On time submissions of FDA-mandated reports, responses to queries, and patent information
•   Must have deep understanding of sciences leading to approval of drugs, biologics, and devices (and combination products)
•   Experienced leading, training and developing regulatory staff

We are proud to be an Affirmative Action/EEO Employer.  EOE Minorities/Females/Protected Veterans/Disabled

We maintain a drug-free workplace and perform pre-employment substance abuse testing.

If you need assistance during the application process due to a disability, please email careers@ferring.com