Manager, Regulatory 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.

Currently looking for a Manager Regulatory Logistics

The incumbent is responsible for providing regulatory input into contract negotiations, liaise with regulatory contract research organizations (CRO) and monitor/track the CRO compliance to contractual obligations. The qualified candidate will provide specific project updates for CRO activities, work with regulatory colleagues on the planning of submissions. Primary focus of responsibility will be the interaction with the CROs for clinical trial application (CTA) registrations, tracking budget changes and negotiating contract requirements. In addition, the candidate will be responsible for tracking new guidances and monitoring the regulatory environment. When new information is found, the candidate will summarize critical points and distribute to appropriate personnel.

This person must be highly organized, able to multitask, work well within the team setting, and prioritize work to meet critical timelines.

RESPONSIBILITIES:

1. Point person with Regulatory Contract Research Organizations (CRO) and internal partner organizations (ex. Finance or Legal) to develop, negotiate, and execute contracts.

2. Track progress of RCO against contractual obligations.

3. Ensure logistical & tactical activities are completed in timely manner.

4. Communicate RCO status to Regulatory Management.

5. Ensure that Company obligations are met in a timely manner (ex. financial responsibilities)

6. Work with Regulatory liaisons to facilitate planning and execution of required activities (ex. submissions, meetings, etc)

7. Monitor and analyze Health Authority and Industry public information, and guidances to keep abreast of evolving and new regulatory standards and issues. Disseminate new information with executive summary.

8. Manage other regulatory financial requirements (Ex FDA product and establishment registration fees)

9. Commitment to excellence, possess both determination and attention to detail, have the ability to produce work to a very high standard

ESSENTIAL KNOWLEDGE,
SKILLS, EXPERIENCE:

1. Must have had exposure to clinical trial applications globally.

2. Must have knowledge of relevant EMEA, ICH, and FDA guidances for both clinical and commercial products.

3. Must possess experience and understanding of IND, BLA and sBLA, CTD/eCTD requirements, and be familiar with global regulatory affairs workflow.

4. Knowledge of FDA, EMEA websites and expertise in the ability to navigate.

5. Experience in managing regulatory information databases.

6. Must have excellent communication skills and be able to establish and maintain relationships with various internal and external personnel.

7. Must have understanding of budgeting process and contract management.

8. Education requirements: Bachelor of Science with 9-14 years of relevant pharmaceutical industry experience. Minimum of 5 years regulatory experience (or equivalent) is required.

Please refer to job code CMS 410195 when responding to this ad.

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