Job Details: Associate Director/Director, Worldwide Regulatory Liaison
| Job Title: | Associate Director/Director, Worldwide Regulatory Liaison |
| Job ID: | Worldwide Regulatory Liaison |
| Company: | FORTUNE 100 PHARMACEUTICAL FIRM |
| Position Type: | Permanent |
| Pay Rate: | - |
| Skills: | MD, 2. Relevant liaisoning experience |
| Date Posted: | May-30-08 |
Description: The incumbent will develop product regulatory strategy for the assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies.
Responsibilities:
· Independently manage projects within assigned therapeutic area and function as the single, accountable and global point of contact
· Achieve optimal results with limited day-to-day direction from the Therapeutic Area Lead
· Function as the first liaison assigned to programs where the compound is first-in-class, or is in a new therapeutic area for the company. Regulatory guidance is not available and the program is extremely accelerated. It is a Joint Venture endeavor and there are multiple indications. The filing is global and/or it is a new disease target with no official regulatory guidance
· Independently interact with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more their investigational and marketed Drugs/Vaccines/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner
· Coordinate the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions
· Ensure regulatory review and final approval of all submissions and associated documentation
· Provide expertise as worldwide regulatory representative to Product Development teams and regulatory single point-of-contact for products within GSRD and external to GSRD
Qualifications:
1. M.D degree
2. Relevant liaisoning experience
Relocation: YES
# of Reports: None
| Location: [rss] | US-PA-Upper Gwynedd |
| Telecommute: | No (Onsite Position) |
| Contact Name: | Michael Douglas |
| Contact Phone: | - |
| Contact Email: | michael.douglas@kgsearch.com |
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Contact Comments:
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ABOUT THE COMPANY: It is world's leading research-driven pharmaceutical company. Consistently ranked by Fortune as one of the "100 Best Companies to work for in America?, they discover, develop and manufacture a wide range of innovative products. Improving patient health isn't just what the company does; it's sharing a passion for life that brings out the best in a diverse workforce. ABOUT KG: A professional services consulting firm hired to directly source prospective candidates. The company?s strategy of maintaining long-term relationships has created a success paradigm that nets great benefits for candidates and clients. Your confidentiality is totally respected. Resumes and other employment-related information are not shared with the client until we have secured your permission. Likewise, we may be asked to maintain client confidentiality. KG provides confidential recruiting support for its corporate clients. Contact info@kgamerica.com to learn how your company can improve its recruiting operations. |
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