Positions Available

DIRECTOR, REGULATORY AFFAIRS
Ferring Pharmaceuticals Inc
4 Gatehall Drive
Parsippany, NJ 07054

Director, Regulatory Affairs: Ferring Pharmaceuticals
Ferring Pharmaceuticals is a research-driven biopharmaceutical company devoted to identifying, developing and marketing innovative products in the fields of infertility, obstetrics, urology, gastroenterology, endocrinology and osteoarthritis. We develop, manufacture and market medicines which work on the body's own terms. Thanks to Ferring thousands of patients every year have their lives enhanced. This makes us proud and constantly pushes us to improve and innovate.

We are currently seeking a Director of Regulatory Affairs in support of development and marketed products within FPI. This individual works closely with management, operations, sales and marketing, outside contractors, and other divisions of Ferring and the FDA. Essential duties and responsibilities include acting as liaison with FDA, as necessary, including arranging and attending face-to-face meetings; advising on regulatory strategy and tactics and follow through to implementation, submission, and approval; preparation of periodic reports to FDA (Annual reports, safety reports); labeling review and submission to FDA; investigational new drug applications, new drug applications; assurance of compliance with CGMPs and CGLPs; advertising and promotional review for compliance with FDA regulations and guidelines. This position also requires an understanding of the process of development and marketing of a drug or drug/device combination including formulation development, stability, transfer of technology to manufacturing/operations for supplies and commercial production, clinical and preclinical development, assisting contractors on compliance with CGMP, CGLP and Pre-approval inspections.

Education Requirements:
M.S. or Ph.D. in relevant science or Pharm.D.

Experience:
M.S.: At least 8-15 years experience in regulatory affairs (including FDA liaison), product development , and project management. Experience on regulation of devices would be an advantage.

Ph.D. or Pharm. D.: At least 5-8 years experience in regulatory affairs (including FDA liaison), product development, and project management. Experience in regulation of devices would be an advantage.

Other Skills
Must have excellent written and communication skills with the ability to interface well with management, marketing and sales, outside contractors and FDA. Required computer skills include Word, Excel, PowerPoint, Microsoft Project, graphics and graphing programs. Must be able to multitask effectively and handle pressure.

Contact:
Karen Gehrig: Tel. 973-796-1644 or Karen.Gehrig@Ferring.com