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Manager, Regulatory Affairs
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Manager, Regulatory Affairs : MedImmune, LLC.
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| Job Number |
02251 |
| Employee Type |
Full Time |
| Company Name |
MedImmune, LLC. |
| Location |
Gaithersburg
Maryland
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| Salary (year) |
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| Start Date |
3/1/2010 |
| Industry |
Biotech |
| Job Type |
Regulatory-Affairs |
| Relocation |
Not Required |
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MedImmune, LLC.
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| Description |
Description
Title: Manager, Regulatory Affairs
Location: MD, Gaithersburg - Corporate Headquarters
Req: 02251
Major Duties and Responsibilities (including supervising others):
1. Provides regulatory guidance during the review and evaluation of change controls, quality investigations, quality audits, that may impact existing or pending licenses or authorizations.
2. Provides regulatory support during inspections by regulatory agencies. Works with QA and Compliance to develop corrective action plans and formulate responses to inspectional findings.
3. Provides strategies, consistent with established regulatory policies and global regulations, to members of assigned project teams in order to facilitate approval of CMC supplements and variations.
4. Interacts with responsible departments and manages the collection, review, and assembly of administrative and CMC sections of submissions to regulatory agencies. Submissions projects may include but are not limited to IND/IMPD/BLA/Annual Reports/ Distribution Reports/MAA/NDA/DMF/Site Master Files/MA/IMP.
5. Establishes submission timelines and manages the timely and comprehensive receipt of information required to meeting submission target dates.
6. Reviews and determines the applicability, accuracy, and completeness of supporting documentation for inclusion in regulatory submissions.
7. Ensure corporate and partner adherence to and compliance with established company quality policies, practices, SOP's, and applicable US, EU and ROW regulations.
8. May manage and supervise associate level staff including defining work products and expectations, organizing and prioritizing projects, and providing mentoring to facilitate staff development and training.
9. Must have excellent oral and written communication skills.
10. Occasional travel to manufacturing sites may be required to ensure efficient communication and expedite submission development. Travel will be in range of 10 – 15% each year.
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
Special Skills/Abilities: Applied knowledge of FDA and EU regulations, GMP and post-approval CMC experience is required. Specific experience in vaccine development and commercial support highly desirable.
Job Complexity: Works on problems of diverse scope where analysis of situation or data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Detail oriented. Able to read large volumes of printed material in a short period of time and be able to identify inconsistencies, incomplete and/or inaccurate information, provide corrections, and changes.
Supervision: Manages and coordinates regulatory projects, works independently with minimum supervision.
(Supervision required, level of independence)
Educational Requirements
Requirements/Qualifications:
Education: Minimum BS/MS in a scientific discipline or equivalent experience. Advanced degree a plus.
Experience: Minimum of 5 years experience in the Pharmaceutical/Biotech Industry with 3 years of related regulatory experience.
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