|
Apply online for the
Director, Regulatory Affairs
position and advance your career in the
Biotech industry today.
|
Director, Regulatory Affairs : Emergent BioSolutions
|
| Employee Type |
Full Time |
| Company Name |
Emergent BioSolutions |
| Location |
Lansing
Michigan
|
| Salary (year) |
|
| Experience |
10 to 15 Years |
| Start Date |
2/1/2012 |
| Industry |
Biotech |
| Job Type |
Regulatory-Affairs |
| Required Degree |
Bachelors of Science |
| Relocation |
Not Required |
|
Emergent BioSolutions
View all jobs from Emergent Biosolutions |
|
|
|
| Apply Online |
| What Does Your Boss Say About You? |
| Description |
|
Director, Regulatory Affairs
Emergent BioSolutions Inc. is a profitable, multinational biopharmaceutical company dedicated to one simple mission -to protect life. We develop, manufacture and commercialize immune-related biologics, consisting of vaccines and therapeutics that assist the body's immune system to prevent or treat infectious and other life-threatening diseases. Our marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine licensed by the U.S. Food and Drug Administration for the prevention of anthrax infection.
We have a current opening for a Director, Regulatory Affairs in our Lansing, MI manufacturing facility. This position is responsible for overseeing regulatory activities for the Company’s Lansing manufacturing facility for the licensed BioThrax vaccine.
Qualified candidates will have a BS degree in a related biological and life sciences field (MS or PhD preferred), and minimum of 12 years of industry experience in Regulatory Affairs for licenses of biological products and biologics in advanced development.
Job Duties:
Oversee all regulatory activities required for routine lot release;
Plan and execute required regulatory filings to maintain product license and establishment registration;
Plan and execute regulatory filings in support of various manufacturing changes to enhance cGMP compliance, production capacity and product improvement
Support international licensing activities when requested;
Provide regulatory guidance to site functional groups regarding all aspects of manufacturing and operational activities;
Provide regulatory support to new product development activities at the Lansing site;
Utilize technical knowledge and effectively apply regulations and guidelines to regulatory filings, and provide authoring, review, and coordination for quality submissions;
Serve as regulatory liaison to the FDA (and other regulatory authorities as may be designated) for assigned projects;
Prepare and communicate regulatory risk assessment to the project teams and senior management;
Manage the Lansing regulatory group and departmental budget.
TO BE CONSIDERED FOR THIS POSITION, YOU MUST APPLY @
https://jobpostings.ebsi.com/prdcss/JobPostings.html
PLEASE REFER TO REQ ID # 1698 |
|
| Requirements |
|
Requirements:
BS degree in related biological and life sciences field (MS or PhD preferred)
12+ years of industry experience in Regulatory Affairs for licenses biological products and biologics in advanced development.
Management of a group including evaluation of performance.
Vaccine experience strongly preferred.
Please refer to job description for more detailed requirements.
Must be able to perform all essential job functions with or without reasonable accommodation. |
|
| Contact Info |
TO BE CONSIDERED FOR THIS POSITION, YOU MUST APPLY @
https://jobpostings.ebsi.com/prdcss/JobPostings.html
PLEASE REFER TO REQ ID # 1698 |
|
Apply online at company website |
|
Find More Biotech Jobs in the Biotech industry.
|
|