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Regulatory Affairs Manager, Sr. Manager-OTC
position and advance your career in the
Pharmaceutical industry today.
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Regulatory Affairs Manager, Sr. Manager-OTC : GlaxoSmithKline
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| Job Number |
57773 |
| Employee Type |
Full Time |
| Company Name |
GlaxoSmithKline |
| Location |
Parsippany
New-Jersey
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| Salary (year) |
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| Experience |
10 to 15 Years |
| Start Date |
1/13/2010 |
| Industry |
Pharmaceutical |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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| Description |
Basic Qualification
• B.S. degree in scientific discipline
• 10+ years Pharmaceutical Industry experience, detailed knowledge of and direct experience in US Regulatory Affairs, good working knowledge of current global Regulatory environment
• Experience with various submission types (IND, NDA, CTA).
• Excellent interpersonal, verbal and written communication skills.
• Ability to effectively manage multiple projects
Details
• Serve as the primary regulatory contact for specific projects and/or program related activities;
• Contribute to the assessment of new innovation projects and exploratory product development briefs;
• Assist in the formulation of regulatory strategies; balance ideas and practices against regulatory risks.
• Compile and submit quality core regulatory dossiers in line with business plans and timing needs;
• Interact with FDA and other regulatory agencies as necessary;
• Collaborate with key cross-functional team members to meet or beat all project goals;
• Review and approve all labelling, promotion, advertising, change controls, etc. for category products;
• Monitor, analyze and advise the GSK business on existing and emerging global regulatory trends and requirements.
• Participate in trade association and professional society activities
• Participate in Departmental Senior Management team activities, as appropriate. |
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| Requirements |
Preferred Qualification
• Graduate degree
• Background in consumer products; Rx to OTC switch experience is desirable.
• Direct supervisory experience |
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| Contact Info |
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Apply online at company website |
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