Associate Vice President, Regulatory Affairs - Parsippany, NJ | Biospace
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Associate Vice President, 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:
Regulatory Affairs, Vice President,

Job Description


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:

o   Navigate and supervise regulatory representatives (Regulatory liaison roles) on project teams, assuring that regulatory strategies are written, understood, and implemented
o   Problem-solve issues that may happen on projects, to preserve original timelines
o   Liaise with FDA during opportunities to comment and impact regulatory policies and Guidelines
o   Work closely with Government Affairs to coordinate efforts and impact programs where there is overlap of efforts.
o   Select, contract, and oversee consultants for scientific and/or policy areas of development
o   Anticipate need for resources and budget those needs in advance.

Requirements



Requirements:
o   Scientific degree.  Pharmacy or Clinical Science preferred; advanced degree or law degree preferred
o   Ex-FDA or demonstrated years of success in approval of drugs, biologics, devices and/or combination products
o   15+ years experience with FDA or US Regulatory Affairs
o   Must have deep understanding of sciences leading to approval of drugs, biologics, and devices (and combination products)
o   Experienced leading, training and developing regulatory staff
o   Flexible, dynamic, and entrepreneurial
o   Supports culture of performance and accountability
o   Ability to foster collaboration amongst team

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