Regulatory Affairs Manager
1 day ago
- Regulatory submissions including Original ANDAs, Amendments, Annual Reports, Supplements and PADERs to company applications.
- Preparation/Review of Original submission/Amendments/ Supplements as assigned by the Director, Regulatory Affairs or VP, Regulatory Affairs.
- Participate in project calls with minimal supervision and work very closely with internal and external project managers, contract manufacturers to ensure timely availability of documents for submission.
- Review the submission documents for accuracy and adequacy and approach the management immediately for any questions or concerns.
- Stay updated on the Agency's expectations based on guidance's/ deficiencies and apply the same logic for future submissions to avoid any similar deficiencies.
- Ensure the facilities used in company's applications commit to GDUFA requirements (site identification, facility fees).
- Degree in Science with at least 10 years of experience in the pharmaceutical industry.
- Understanding of regulations relating to generic pharmaceuticals.
- Understanding of generic drug approval process and associate regulations.
- Capable of technical review of documents submitted in applications.
- Organizational skills and multi-tasking.
- Excellent written and verbal communication skills.
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Regulatory Affairs Principal
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(Sr.) Regulatory Affairs Specialist
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(Sr.) Regulatory Affairs Specialist
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Sr. HW Regulatory Compliance Engineer
3 days ago
Sunnyvale, CA, United States Amazon Full timeAmazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of Amazon.com, Inc., originally creating the best-selling Kindle family of products. Since then, we have produced devices like Fire tablets, Fire TV, and Echo. What will you help us create? The Sr....
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Sr. HW Regulatory Compliance Engineer
5 days ago
Sunnyvale, CA, United States Amazon Full timeAmazon Lab126 is an inventive research and development company that designs and engineers high-profile consumer electronics. Lab126 began in 2004 as a subsidiary of Amazon.com, Inc., originally creating the best-selling Kindle family of products. Since then, we have produced devices like Fire tablets, Fire TV, and Echo. What will you help us create? The Sr....
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Sr. Director
1 week ago
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Sr. Director
5 days ago
Sunnyvale, CA, United States KayeBassman Full timeKaye/Bassman Internationa l is a leading executive search firm that has been filling roles for Pharma and Biotech clients for over 35 years. Our Medical Affairs search practice is led by Michael Pietrack , a leading Medical Affairs recruiter and the host of The Pharmaverse Podcast . In this short video , Michael introduces the role.Senior Director - Health...
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Concentra Physical Therapist
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Concentra Physical Therapist
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Concentra Physical Therapist
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