Associate Director or Director Regulatory Stragetic Research

Title: Associate Director / Director, Strategic Research (Reg Affairs)
Located in central NJ, this is a biopharmaceutical company dedicated to developing breakthrough biologic medicines in the area of oncology. The Company has utilized the many advances made in the fields of molecular biology, oncology, genomics, and antibody engineering to build a novel pipeline of product candidates designed to address specific genetic mechanisms involved in cancer growth and development.
Their goal is to become a fully-integrated biopharmaceutical company that has the capability and resources to take its novel pipeline compounds and develop them from the research and development stage through to commercial manufacture, marketing and sales.  With their first innovative cancer drug on the market and late stage clinical candidates soon to be, they have cooperative agreements with several big pharmaceutical companies to help market their drugs. This is a solid, fast growing midsized company which incorporates the best of both worlds, security with room to grow.

GENERAL SUMMARY:
Responsible for mining all available public resources concerning regulatory agency positions/actions and providing articulate and concise summaries of that information as needed within the Company for inclusion in both regulatory documents and to inform strategic decision making. Monitor health authority activities to inform the company about key changes in procedures that can effect the business.

ESSENTIAL DUTIES AND
RESPONSIBILITIES:

1.Research FDA website to gather information as needed, (and as directed by Regulatory Management) on oncology drug approval precedents and provide summaries of information
2.Research EMEA website to gather information as needed, (and as directed by Regulatory Management) on oncology drug approval precedents and provide summaries of information
3.Research other HA information through the use of proprietary software (IDRAAC) to inform about guidance standards worldwide, both procedurally and related to approval decisions.
4.Monitor HA activities to inform the organization about important new guidances that may effect the business

ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:

1.Advanced degree in biology, pharmacy or related degree.
2.At least 10 years in pharmaceutical industry with drug development/regulatory familiarity.
3.Applicable technical writing experience (preferably regulatory submissions), oncology preferred.
4.Excellent written and verbal communication skills
5.Proficiency in MS Word.
6.Experience with document management systems (i.e., Documentum) is preferred.
7.Ability to multitask.

Category:	Biotech/Pharmaceutical
	> Regulatory Affairs
Location:	Bridgewater, NJ
County:	Somerset County
ZIP Code:	08807
Pay Rate:	Competitive
Job Terms:	full time
Company:	Discovery Solutions, Inc.
Phone:	(443)402-1582
Fax:	410-510-1240