Regulatory CMC Biotech Liaison Manager Job

Employer Name: BiotechCrossing	SpiderID: 2339122
Location: Somerville, New Jersey	Date Posted: 7/4/2008
Wage:	Category: Biotech
Job Code: 5889763

Job Description:
Manager will establish and maintain sound working relationships with partners and customers, initiate and lead regional Health Authority interactions and negotiations as appropriate; setting objectives, preparing briefing books, coordinating and planning rehearsals, lead cross-functional Health Authority Response Teams (HARTs) for assigned development projects and/or marketed products, as appropriate, lead preparation of CMC dossier risk analyses, contingency plans and Lessons Learned documentation on major submissions for communication and action planning with subteams, represent Reg CMC, and therefore provide input to licensing decisions, on due diligence and divestment teams, represent Reg CMC on teams for continuous improvement within and outside the department, provide leadership within the department through specialized matrix functions and by utilizing CMC regulatory expertise to drive improvements, act as mentor/coach to all Reg CMC members, provide training on critical regulatory points of CMC documentation and lessons learned within and outside the department and deputize and support the group head as necessary, including review and approval of CMC documentation. Responsible for own regional strategic and operational project work, including that for complex and/or heavyweight/key or complex projects/products.

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Job Criteria:
Start Date:
Position Type: Full-Time Permanent
Years of Experience Required:
Education Required:
Overnight Travel:
Vacation Time:

Contact Information:

Contact Name: -	Company Type: Employer
Company: BiotechCrossing

City: Pasadena
State: California
Zip:

Web Site: http://www.biotechcrossing.com