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| Job #03006 |
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| About our client |
| Our client is a pharmaceutical company that develops, manufactures and markets pharmaceutical therapeutics for medical conditions requiring specialized treatment. The company’s prescription drugs are marketed both nationally and internationally. |
| Position |
Location |
| Director of Regulatory Affairs |
Pennsylvania |
| Salary |
| Highly competitive package, commensurate with experience |
| Responsibilities |
1) Contribute to developing regulatory strategies to support registration filings and approval of new products
2) Maintain contact with regulatory authorities on issues related to the submission and approval of product dossiers
3) Interact with regulatory authorities during product development and provide support for FDA meetings
4) Contribute to the maintenance and regulatory management of all registration dossiers for all marketed products as well as any products under development
5) Identify areas of organizational weakness from a regulatory perspective
6) Contribute to the development of an effective and efficient organizational
structure organizational structure
7) Interact with FDA and outside consultants to resolve issues
8) Oversee staffing requirements at company's office in India
9) Identify appropriate personnel resources and hire to meet defined business
and project objectives
10) Evaluate change control requirements that impact products |
| Requirements |
1) BA/BS
2) 10+ years of experience in pharmaceuticals including 3 – 5 years of supervisory experience
3) Familiarity with manufacturing facilities/sites and extensive experience in auditing such facilities/sites
4) Membership and certification in application professional organizations a plus
5) Demonstrated technical leadership as well as project and group leadership skills
6) Ability to interact with diverse departments to initiate and complete projects on time
7) Previous experience managing and supervising staff in India
8) Highly motivated |
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