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Regulatory Affairs Associate/Manager
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Pharmaceutical industry today.
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Regulatory Affairs Associate/Manager : GlaxoSmithKline
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| Job Number |
61145 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Parsippany
New-Jersey
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| Salary (year) |
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| Experience |
2 to 5 Years |
| Start Date |
7/16/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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| Description |
Basic Qualification
BS/BA degree in a scientific discipline
• 6+ years experience within Global Regulatory Affairs.
• Working knowledge of current Global Regulatory Affairs,
• Ability to interpret and understand government regulations.
• Awareness and ability to work within areas of cultural difference.
• Ability to prioritize team activities and issues.
• Excellent interpersonal, verbal and written communication skills.
• Experience with electronic regulatory submissions and document management systems.
• Experience with CTD submissions for IND/CTA/NDA/MAA/CTAs a plus.
• Strong PC skills
Details
• Serve as the primary regulatory contact for specific projects and/or program related activities
• Serve as regulatory partner for category team
• Contribute to the assessment of new innovation projects and exploratory product development briefs
• Assist in the formulation of regulatory strategies designed to minimize time for development and regulatory approval and optimize competitive positioning and global opportunities
• Compile and submit quality core regulatory dossiers in line with business plans and timing needs
• Interact with GSK country regulatory managers and other regulatory agencies as necessary in relation to the development and marketing of products
• Collaborate with key cross-functional team members to meet or beat all project goals
• Review and approve all labeling, promotion, advertising, change controls, etc. for category products
• Monitor, analyze and advise the GSK business on existing and emerging global regulatory trends and requirements. Balance ideas and practices against regulatory risks
• Participate in trade association and professional society activities, such as RAPS, CHPA, etc., where appropriate
• Participate in Departmental Senior Management team activities, as appropriate. |
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| Requirements |
Preferred Qualification
Experience with medical device regulations for US; experience with EU regulations and Medical Device Technical Files
• Detailed knowledge of US Regulatory Affairs.
• Graduate degree preferred.
• Background in consumer products is preferred.
• Ability to summarize key issues for extended team and management.
• Demonstrated strength in facilitating projects and multiple tasks.
• Ability to negotiate and influence positively at multiple levels, internal and external. |
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| Contact Info |
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