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Associate Director, Regulatory Affairs
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Associate Director, Regulatory Affairs : MedImmune, LLC.
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| Job Number |
02196 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
2/9/2010 |
| Industry |
Biotech |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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| Description |
Description
Title: Associate Director, Regulatory Affairs
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02196
Position Summary:
Responsible for preparing, implementing, communicating, and coordinating regulatory projects, plans and schedules with scientific (clinical and preclinical), manufacturing, and business development project team members for biological products proposed for oncologic indications. Responsible for collecting, preparing and assembling documentation required for Investigational New Drug Applications, and Biologic License Applications.
Major Duties and Responsibilities:
1. Lead innovative regulatory strategy development for all phases of drug development for biological investigational products
2. Monitors product related corporate activities for regulatory compliance, including all manufacturing, preclinical and clinical plans and practices.
3. Represents Regulatory Affairs and provide guidance to Research, Development, Clinical and Manufacturing at Project Team meetings.
4. Interacts with responsible departments and manages collection, review, and assembling of the scientific (preclinical, clinical, and manufacturing) and administrative sections of submissions to regulatory agencies.
5. Submits regulatory information to FDA and world-wide regulatory agencies including, but not limited to, INDs, BLAs, and manufacturing, preclinical and clinical protocols and amendments, and adverse
experience reports.
6. Plan, coordinate, prepare and execute meetings and teleconferences with regulatory agencies.
7. Prepares, manages, and coordinates clinical trial applications and clinical trial labeling with world-wide Contract Research Organizations and Consultants.
8. Reviews and determines the applicability of supporting documentation for inclusion in regulatory submission.
9. Reviews all supporting documentation required in regulatory applications for accuracy and completeness.
10. Interact with Company Partners and Consultants for various regulatory matters as needed.
11. Must be action oriented, have customer focus and excellent time management and organizing skills
About the Organization
My company shares my
passion for helping to improve human health around the world."
"This is My MedImmune."
Those who join MedImmune feel a sense of ownership about their future. They thrive with a recognized leader in the biotechnology industry and the wholly-owned subsidiary of AstraZeneca plc.
Here, you will join passionate professionals who advance science, technology and medicine to develop products designed to help people live better lives. You will excel in an environment characterized by respect, integrity and growth opportunities…that encourages both individual contribution and collaborative entrepreneurial thinking. Our products and/or product candidates are designed to address areas of need in infection, oncology, respiratory disease and inflammation, cardiovascular/gastrointestinal disease and neuroscience. Explore a MedImmune career as we strive to better more lives, more often, around the world.
Company Information
MedImmune, LLC. is an Equal Opportunity Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, veteran status, or any other characteristic protected by federal, state or local law.
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| Requirements |
Position Requirements
Experience: For Associate Director a minimum of 5 years experience in Regulatory Affairs. Knowledge of FDA regulations required. Regulatory experience in biological products required. Direct liaison experience with FDA required. Knowledge of international regulatory guidelines, GCP and GMP requirements is desirable.
Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
Supervision: Manages and coordinates regulatory projects, works independently with minimum supervision. Will hire and supervise subordinate staff (e.g., managers and associates) when scope of project requires. Acts as advisor to subordinate(s) to meet schedules and/or resolve technical problems.
Educational Requirements
Education: BS/MS or Ph.D in a scientific discipline or equivalent experienc
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