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Biopharm CMC Regulatory Associate or Manager
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Pharmaceutical industry today.
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Biopharm CMC Regulatory Associate or Manager : GlaxoSmithKline
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| Job Number |
54227 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
King of Prussia
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
6/2/2009 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Required Degree |
Bachelors Degree |
| Relocation |
Not Required |
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| Description |
Basic Qualification
Basic qualifications:
- degree in Biology, Biochemistry, Molecular Biology, Chemistry or related field
- understanding of the fundamentals of biologics/biopharmaceuticals development, with experience gained through a manufacturing, support or a regulatory function
- an understanding of global regulatory CMC requirements and guidelines (FDA, EMEA, ICH) and track record of successful negotiations with agencies
- detail-oriented with excellent communication skills (both oral and written)
- interpersonal, negotiation and problem solving skills
- a proven track record of preparing and reviewing regulatory documentation
- the ability to work effectively in matrix teams
- computer literacy and ability to learn new systems and processes
Details
You will support global regulatory submissions for projects within an expanding CMC Regulatory team dedicated to biopharmaceutical development. This team is situated in the US (King of Prussia, PA) and UK (Harlow) and is part of a Global Regulatory Affairs organisation within R&D.
Key aspects of this role:
• Liaise closely with colleagues in development and manufacturing functions to lead and drive CMC regulatory activities
• Interpret and advise on global regulations, guidelines, procedures and policies relating to development, registration and manufacture of biopharmaceutical products
• Lead the preparation and delivery of the CMC sections of investigational and license applications
• Deliver regulatory submissions through membership on cross functional teams by effective planning, coordination and communication
• Drive the regulatory strategy for submissions and response to questions from Health Authorities worldwide
• Support process improvements and implementation of best practices
• Work closely with GSK partners in joint-development projects to achieve business objectives
• Liaise closely and effectively with colleagues across regulatory affairs
Your personal qualities will include excellent team working skills and the ability to communicate at all levels. You should have a keen eye for detail and have demonstrated innovative problem solving skills. Self-motivated, you will be able to adopt a proactive and positive approach to your work, and be proficient at organizing your workload. The ability to work innovatively, under pressure and deliver results to tight deadlines is essential. |
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| Requirements |
Preferred Qualification
Preferred qualifications:
- technical expertise in a discipline related to biologicals and/or biopharmaceuticals (e.g. monoclonal antibodies and therapeutic proteins) manufacturing or control
- ability to recognize business needs, think strategically and develop risk mitigation strategies
- effective coordination of activities on multiple projects simultaneously with the ability to work to tight deadlines |
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| Contact Info |
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