Consultant Regulatory Affaire Job in King Of Prussia 19406, Pennsylvania Us
Responsibilities:
- Serves as the RA representative to the core project teams or represents the RA site as project teams for assigned projects providing regulatory support for investigational projects and market applications.
- Serves as FDA contact for assigned projects. Work with management and Project Team members to develop strategies and advice for addressing the issues for developmental and marketed products.
- Represent the company during interactions with regulatory agencies.
- Prepare or manage the preparation and submission of regulatory applications, reports and correspondence to regulatory agencies.
- Schedule, coordinate, prepare, and review Investigational Applications (original submissions and amendments) and Market Applications (original submissions and supplements) in cooperation with the Project Team members.
- As assigned, review advertising and promotion pieces.
- Monitor current and proposed regulatory and legal issues through external meetings, workshops, and the Internet.
- Author and maintain Standard Operating Procedures and Local Working Practices as assigned.
Experience:
- BS, BA in Life Science or advanced degrees.
- Regulatory Experience 5 to 7 years with pharmaceutical or related.
- Must have exceptional organizational skills and knowledge of FDA regulatory requirements and ICH guidance.
- Interpersonal, administrative, written, and verbal skills required.
- Requires a self-starter with the ability to work on his/her own as well as define, coordinate and direct assignments to project team members.
April 6, 2009
• Tags: Consultant Regulatory Affaire Job in King Of Prussia 19406, Pennsylvania Us • Posted in: General