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| Company: |
Sterling Life Sciences |
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| Job Title: |
Regulatory Affairs Manager |
| Job Category: |
Biotech |
| Job Location: |
San Diego - CA California - USA |
| Job Ref. Number for your records: |
2434 |
| Job Description: |
Our client is a biopharmaceutical company based in San Diego. The company focuses on in-licensing, developing and commercializing products pharmaceuticals to meet the needs of hospitalized patients and their care givers. Since their inception in 2004, they have in-licensed rights to two Phase III products, both of which have been studied in previous Phase III clinical trials conducted by their licensors.
Job Responsibilities:
1) Provide regulatory research, as well as regulatory assistance to the project team, in support of ongoing efforts towards gaining marketing authorization for company’s products
2) Review critical documents (i.e. protocols, ICFs) for submission to health authorities, in order to confirm adherence to regulatory requirements
3) Coordinate and prepare regulatory submissions to health authorities worldwide
4) Perform bookmarking, hyperlinking, tracking, and reviewing for regulatory compliance activities in the preparation of NDAs and MAAs
5) Provide guidance and direction to junior level regulatory employees
Job Requirements:
1) Bachelor’s degree
2) Minimum 5-10 years of regulatory experience in the pharmaceutical industry/equivalent
3) Experience in preparing documents for eCTD submissions
4) Technical knowledge of US regulations
5) Ability to identify documents that are not eCTD compliant
6) Knowledge of ICH and GXP Guidelines
7) Ability to coordinate regulatory submissions with minimal supervision
8) Proficiency in computer and word processing skills
9) Strong attention to detail and organizational skills
10) Strong written communication and interpersonal skills
11) Willingness to travel up to 10%
Applicants are encouraged to apply directly by going to: Sterling Life Sciences job board
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| Skills Required: |
8) Proficiency in computer and word processing skills
9) Strong attention to detail and organizational skills
10) Strong written communication and interpersonal skills
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| Language Requirements: |
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| Employment Type: |
Full Time
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| Yearly Salary: |
115 USD
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| Posting Date: |
Oct 19 2007 |
| Education level required: |
Bachelor
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| Experience (in years): |
3 to 5 Years |
| Company: |
Sterling Life Sciences |
| Contact Name: |
Sterling Life Sciences |
| Preferred Method of Contact: |
No Preference |
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