Title: Director of Regulatory Affairs, Early Development Investigational Products

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

Directly responsible for the organization and preparation of IND/CTA submissions.  Coordinates the activities required to maintain the IND/CTA filings in Regulatory Compliance.  Participates in compliance activities including SOP creation/revision and departmental training exercises.

ESSENTIAL DUTIES AND

RESPONSIBILITIES

1. Direct the preparation (content ) of submissions (INDs, IND amendments, CTAs, CTA amendments, BLAs and BLA supplements and periodic reports) to the Health Agencies. Responsible for coordination with Regulatory CROs for CTA activites if appropriate.

2. Responsible for direct coordination /liaison between Health Agency representatives and function groups within ImClone.

3. Provide guidance to multifunctional development teams concerning strategic decisions and health authority interactions.

4. Responsible for liaison activities with functional groups within ImClone to ensure timely and accurate reporting of information.

5. Participates in the creation, review and revision of the department policies, work instructions and standard operating procedures.

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE

1. BS/MS/PhD in life science with minimum of 5 years experience in regulatory affairs

2. Must possess a thorough understanding of the drug development/regulatory process with stong experience in biologic oncology development.

3. Experience in GCPs and regulatory compliance preferable.

4. Demonstrate a thorough knowledge of the intent, meaning, interpretation and application of FDA and ICH regulations.  Knowledge of foreign regulations, guidelines and practices for conducting clinical investigations is desired.

To apply:

Please reply to:

Debbie Wilmer

Discovery Solutions LLC

443-402-1585

Debbie.wilmer@discoverysolutionsllc.com

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